As demand for noninvasive saliva-based COVID-19 testing increases, Fluidigm has launched COVID-19 Community Connect, a network of testing partners to increase access to saliva-based SARS-CoV-2 testing.
“Since announcing our Emergency Use Authorization for saliva-based PCR testing in late August, we have seen tremendous interest in our testing technology,” said Chris Linthwaite, Fluidigm President and CEO. “We created the Community Connect program to organize a system for assessing needs, recruiting lab partners and building a service ecosystem for delivering timely results. “
“We have been building a network of partner labs for a number of weeks, and we welcome additional partners as well as general inquiries from groups seeking reliable, cost-effective and easy-to-administer tests,” Linthwaite added.
Working with Thermo Fisher Scientific, the University of Oxford has been able to ramp up its capacity to deliver COVID-19 testing data. The new rapid testing laboratory and jointly developed Thermo Scientific OmnipathTM Combi SARS-CoV-2 IgG ELISA test detects and quantifies antibodies against the coronavirus and increases the University of Oxford’s testing capacity to up to 50,000 tests per day.
Oxford researchers are already using the new fully automated testing platform to provide weekly U.K.-wide data for the Office of National Statistics as part of the national COVID-19 Infection Survey. In addition, the equipment further enhances Oxford’s capacity to quantify the response to vaccines accurately and on a large scale as part of our ongoing clinical trials of the Oxford coronavirus vaccine to assess vaccine performance.
EUROIMMUN, a PerkinElmer company, has launched the Anti-SARS-CoV-2 QuantiVacTM ELISA (IgG) to quantify IgG antibodies against the SARS-CoV-2 S1 antigen. The assay is available for countries accepting the CE mark, and the company intends to seek Emergency Use Authorization from the U.S. FDA.
This quantitative test kit applies a recombinant S1 subunit of the SARS-CoV-2 spike protein, enabling detection of IgG antibodies. These antibodies have been the focus of vaccine development programs as well as discussions about possible immunity in previously infected individuals.
“The global research and medical community is focused on having an effective SARS-CoV-2 vaccine available as soon as possible, but to do so, it’s clear that the quantitative measurement of antibodies in clinical studies will play a huge part,“ said Dr. Wolfgang Schlumberger, CEO. “The EUROIMMUN assays, especially the S1-based tests, are important tools for pharmaceutical laboratories conducting clinical trials. Our assays can help to identify individuals who have been exposed to SARS-CoV-2 and may play a critical role in accurate evaluation of antibody status before and after infection, in antibody therapies or in vaccination programs.”
eTheRNA has expanded its mRNA production services to include high-throughout research-grade mRNA in addition to its GMP capabilities. The company can develop processes and manufacture mRNA in amounts ranging from research and preclinical batches to full GMP production lots for clinical trial supplies.
“We have extended our contract manufacturing services in response to a growing number of requests from third parties from around the world. With our two purpose-built mRNA-units, we have the optimal infrastructure to support mRNA-based projects from initial plasmid DNA development and optimization, through linearization, in-vitro translation, mRNA purification and quality control to industrialized GMP production. We can support customers ranging from small academic groups with whom we can partner through to established companies looking for GMP manufacturing capacity.”
PerkinElmer received Emergency Use Authorization to allow sample pooling with its new Coronavirus Nucleic Acid Detection Kit to increase the number of individuals who can be tested without increasing resources.
CLIA labs can now use PerkinElmer’s real-time RT-PCR in vitro diagnostic assay for COVID-19 to pool multiple samples together using the resources needed for a single test. If a pooled test is negative, all the individual samples are considered negative. If the pooled test is positive, each of the individual samples in that pool should be tested again separately to determine which of the samples are positive. For sample pooling to be effective, screening using a highly sensitive test is integral.
According to PerkinElmer, its new Coronavirus Nucleic Acid Detection Kit has the lowest Limit of Detection (LoD) among the authorized COVID-19 molecular diagnostic tests reported, deeming it the most sensitive assay that can detect threefold less viral material in samples compared to the assay in second place, and over 90-fold times less viral material in samples compared to the industry average.
Mammoth Biosciences has signed agreements with MilliporeSigma and Hamilton Company targeting commercialization of a high-throughput CRISPR-based SARS CoV-2 test. The test leverages Mammoth’s DETECTR BOOST™ platform and aims to provide a sample-to-answer turnkey solution for commercial laboratories to enable a multi-fold increase in testing capacity.
Mammoth Biosciences says it is poised to help reduce the backlog created by limited capacity and testing supply shortages by working with leading manufacturing and automation vendors for its CRISPR-based SARS-CoV-2 molecular assay. The systems will be compatible with both nasal swab and saliva samples and are targeting 1500 tests per 8-hour shift with minimal user interaction. Mammoth Biosciences plans to submit the assay for FDA EUA later this year.
Mammoth reports that its DETECTR BOOST™ SARS-CoV-2 assay reagent kits, which will be contract manufactured by MilliporeSigma, rival PCR in sensitivity while being less prone to supply chain risk. The testing system will also leverage standard, automated liquid handling equipment such as those from Hamilton Company to enable rapid processing of patient samples.
Cytiva announced today the launch of Cytiva Diagnostic Services, which will help developers bring point-of-care diagnostic tests to market quicker through infrastructure, expertise, and consultation for point of care immunoassay development. A multi-million dollar investment will be used partly to expand chemistry labs in Cardiff, Wales, as well as establish design labs in Germany and China.
Cytiva has already been working with diagnostic developers during the COVID-19 pandemic. In total, over 50 million people have been PCR tested using components or services from Cytiva. Diagnostic components, such as nitrocellulose membranes, are used in 18 immunoassay-based COVID-19 tests available today. The new services will follow the same collaborative approach as Cytiva's work with Avacta. The companies are co-developing a rapid antigen test strip for COVID-19 to provide a result in minutes using patient saliva.
The new services will include training, test optimization expertise and contract development and can be hosted virtually or in person at Cytiva's new lab in Dassel, Germany. Another lab for diagnostics development work is being planned for China in 2021. These projects form part of Cytiva's 500 million USD investment over five years to expand manufacturing capacity.
Taconic Biosciences just announced the availability of the hACE2 AC70 mouse model to support COVID-19 vaccine and therapeutic evaluation as well as basic research into disease pathogenesis.
The hACE2 AC70 mouse model expresses human ACE2 cDNA under the control of the CAG promoter, making it susceptible to SARS-CoV-2 infection. ACE2 is the receptor bound by SARS-CoV-2 and SARS-CoV spike proteins during viral entry into host cells; these spike proteins have a much higher binding affinity to human ACE2 compared to mouse ACE2.
Following intranasal infection with SARS-CoV-2 above a threshold dose, the hACE2 AC70 mice display severe symptoms, including rapid weight loss and death.
The new mouse model is available for purchase under Taconic's label license, meaning no MTA to sign or license fee.
Erich Jarvis from Rockefeller University is bringing his expertise in comparative genomics to the COVID-19 Host Genome SV Consortium, which is centered around the analysis of structural variants in the human genome that predispose to or protect against COVID-19. Identifying such variants in the genome can lead to the development of novel drugs, the repurposing of existing drugs for COVID-19, the development of targeted vaccines and importantly, the identification of risk markers that allow better triaging of patients who need certain treatment or early access to vaccines.
Dr. Jarvis’ team will compare the genomes of different species with and without certain traits to help reveal the variants responsible for the traits of interest. In the case of COVID-19 response, the genomes of animals that are believed to be sensitive to SARS-CoV-2 infection will be compared to genomes of species presumed to be immune to infection or disease. The non-human animal species that were susceptible to SARS-CoV-2 infection to be included in the study are the Chinese horseshoe bat, the Chinese pangolin, the clouded leopard, and four domestic species that are believed to be vulnerable: the sheep, Arabian camel, horse and Chinese hamster.
For the human arm of the study, the Jarvis team will analyze the genomes of ten patients who were hospitalized and/or died from COVID-19. The genomes of ten individuals who did not get sick after exposure will function as controls along with those of more than one hundred vertebrate species assembled by the VGP and presumed to be resistant to infection.
Analysis by comparative genomics requires complete genome assemblies for the species to be analyzed, and those assemblies have to be as accurate and complete as possible. The genome assembly team has developed and optimized a pipeline utilizing long-read sequencing, optical maps from Bionano Genomics, and a method called Hi-C to build reference-quality genomes.
Medicago has inked an agreement to supply the Government of Canada with up to 76 million doses of its vaccine against COVID-19, produced using its plant-based platform. Medicago will also receive $173M in funding support from the Government of Canada for its vaccine research and development, and for the construction of its Quebec City manufacturing facility.
On March 12, Medicago announced the successful production of coronavirus Virus-Like Particle (VLP) in just 20 days after receiving the virus gene, thus having a viable vaccine candidate for COVID-19. Medicago initiated preclinical trials with the financial support from the Government of Quebec and began Phase 1 testing on July 14 in human volunteers. Medicago plans to initiate Phase 2 trials in early November, and Phase 3 trials shortly after, in December 2020.
DxTerity Diagnostics received Emergency Use Authorization from the U.S FDA for its SARS-CoV-2 RT-PCR test, SafeWorkDx™, which can be taken unsupervised from home, as well as in the workplace. Self-collected saliva samples are shipped for analysis and results are delivered within a short turnaround time.
DxTerity's SARS-CoV-2 test has been authorized for testing specimens collected from individuals suspected of COVID-19 by their healthcare provider and from any individual, including from individuals without symptoms or other reasons to suspect COVID-19. The testing process provides sample collection materials and a 48-hour stabilization kit for transport of samples, with instructions and shipping materials included. The kit is equipped with a SDNA-1000 Saliva Collection Device and provides secure barcoded tracking of specimen to ensure the samples can be de-identified and accurately traced for security and privacy purposes.
Thermo Fisher Scientific launched a new highly automated, real-time PCR solution designed to analyze up to 6,000 samples in a single day to meet increasing global demand for COVID-19 testing. The high-throughput system enables laboratories to double or even triple their testing capacity to support global efforts to return communities back to work and school, according to the company.
The Thermo Fisher Scientific Amplitude Solution is a molecular diagnostic testing system that leverages the company's Applied Biosystems QuantStudio 7 Flex Real-time PCR instruments along with liquid handling products from Tecan Group. The modular solution delivers test results in a four-step process requiring minimal hands-on time, laboratory space, and staffing resources.
As part of this offering, Amplitude Solution customers will enter into a supply agreement with Thermo Fisher to secure an up-front, confirmed and reliable supply of reagents and consumables.
Intravacc and Celonic Group, a contract development and manufacturing organization (CDMO), signed a research agreement to further design, develop, and produce a COVID-19 vaccine based on an immunogenic Spike (S) protein of SARS-CoV-2 combined with Intravacc’s proprietary Outer Membrane Vesicle (OMV) technology.
For this joint vaccine development, Intravacc combines its OMV delivery platform with S-proteins expressed by Celonic Group’s CHOvolution® mammalian cell expression sytem, in an attempt to generate a balanced B and T cell response against SARS-CoV-2. Swiss-based Celonic Group will construct cell lines producing the S-protein in high quantities and develop a GMP production process. Preclinical studies will start shortly to select the best candidate protein for the vaccine. The collaboration aims to accelerate development of Intravacc’s COVID-19 OMV protein vaccine, which is expected to enter clinical testing in 2021.
“Several studies have shown that OMVs have the ability to enhance the immune response and can be relatively easily formulated with target specific peptides and proteins,” says Jan Groen, Intravcc’s CEO. “This, combined with the fact they can be quickly scaled-up for manufacturing, makes it an ideal suited platform under the current circumstances where quantity and speed are critical,” they conclude.
Novavax, which recently received a $1.6 billion award from the U.S. government as part of Operation Warp Speed (OWS), reported that FUJIFILM Diosynth Biotechnologies (FDB) has begun production of the bulk drug substance for NVX-CoV2373, Novavax’ COVID-19 vaccine candidate, at its site in Morrisville, North Carolina.
Novavax is using its OWS funding to complete late-stage clinical development, including a Phase 3 clinical trial; establish large-scale manufacturing; and deliver 100 million doses of NVX CoV2373 beginning as early as late 2020. NVX-CoV2373 consists of a stable, prefusion protein made using Novavax’ nanoparticle technology and includes Novavax’ Matrix M™ adjuvant. The batches produced at the FDB site in North Carolina will be utilized in a future Phase 3 clinical trial of up to 30,000 subjects which is expected to begin in the fall of 2020.
Novavax’ Phase 1/2 clinical trial of NVX-CoV2373 in 130 healthy participants 18 to 59 years of age began in Australia in May. Novavax says it will announce the Phase 1 data during the first week of August. The Phase 2 portion to assess immunity, safety, and COVID-19 disease reduction is expected to begin shortly thereafter.
Exosome Diagnostics, a Bio-Techne brand, launched ExoCovid-19 test for the detection of SARS-CoV-2 in patient samples. The ExoCovid-19 test will be performed in its CLIA-certified, CAP-accredited laboratory.
Exosome Diagnostics has expanded its laboratory capabilities to perform qualitative multiplexing nucleic acid analysis for the sensitive detection and identification of SARS-CoV-2 virus in nasal, nasopharyngeal, and bronchoalveolar lavage patient specimens.
The company has also validated the CDC-approved assay, which has been granted Emergency Use Authorization (EUA) by the U.S. FDA. Unlike many of the earlier tests currently available on the market, the ExoCovid-19 collection kit offers a minimally invasive nasal swab (anterior nares), which enables patients to comfortably self-collect a specimen while maintaining physical distancing from a healthcare provider.
PerkinElmer has launched two online, free-access COVID-19 Data Dashboards to help the scientific community accelerate the discovery of COVID-19 antivirals and vaccines.
The dashboards are supported by PerkinElmer’s Signals™ Lead Discovery and the TIBCO Spotfire® advanced analytics platform. Together, they provide a robust, easy-to-use solution for searching, aggregating, and visualizing complex, scientific data, according to the company.
Using the PerkinElmer COVID-19 Drug Compound Dashboard, scientists can narrow down the 1.6 million drug compounds that are publicly available by querying a curated chemical substance dataset and related activity data provided by CAS. The included CAS COVID-19 Antiviral Candidate Compound Dataset is an open source data collection assembled by CAS scientists from the CAS REGISTRY®. This, combined with the dashboard’s ability to cross-reference against 15 million bioactivity data points of drug-like molecules from ChEMBL can help researchers narrow the field down to 100 or less key compounds relevant to them for further exploration.
The second resource, the PerkinElmer COVID-19 Clinical Trial Dashboard, pulls together data from sources such as clinicaltrials.gov. Here, scientists can select relevant information on trials for COVID-19 including trial status, lead organization(s), drug compounds being studied and use of live or dead virus, antibody, antiviral or DNA-based vaccine approaches.
“As global scientists work tirelessly to create or repurpose antiviral drugs and vaccines for COVID-19, there are massive amounts of existing public data that can be invaluable to these efforts. However, bringing together, combing through and harnessing that data in real time can be a real challenge,” said Kevin Willoe VP, GM of Informatics, PerkinElmer. “By collaborating with organizations like TIBCO and CAS on the new PerkinElmer COVID-19 Dashboards, we put the power of analytics at the fingertips of scientists to help drive actionable insights earlier in the discovery process.”
A Junshi Biosciences’ SARS-CoV-2 neutralizing antibody, expressed using Lonza’s GS Xceed® Gene Expression System, has entered clinical trials in China. According to the company, the first volunteer has been dosed in a Phase I clinical study of JS016 at Huashan Hospital.
At the start of the COVID-19 outbreak, Junshi Biosciences launched a research and development program focused on neutralizing antibodies using Lonza's GS Xceed expression system. Within two months, the company had completed IND-enabling preclinical studies, process development, and production for GLP toxicity studies, as well as the GMP production of clinical material. Junshi Biosciences is collaborating with Eli Lilly and Company to co-develop JS016 globally, with Junshi leading clinical development in Greater China and Lilly leading clinical development in the rest of the world.
The GS Xceed Expression System is Lonza’s expression technology platform that includes host cell lines, vectors, and access to optimized media and feeds, as well as comprehensive methods and processes. This scalable system can express a diverse range of biologic drugs and has successfully taking programs from gene through cell line construction to commercial products. This expression system is expected to provide valuable support for the JS016 program by helping to improve cell line development timelines and improving yields.
Sonora Quest Laboratories and PerkinElmer are working with the Arizona Department of Health Services to expand COVID-19 testing capacity in Arizona.
Sonora Quest expects to process 35,000 diagnostic tests per day by the end of July, and up to 60,000 tests per day by the end of August. The partners are currently in the process of installing, validating and deploying new production lines that will include chemagic™ 360 instruments, JANUS® G3 Primary Sample Reformatters, and PCR+ Workstations, to automate PerkinElmer’s RNA extraction and RT-PCR testing.
“Despite the recent resurgence of COVID-19 cases in the United States and some testing locations experiencing capacity shortfalls, PerkinElmer has complete SARS-CoV-2 testing solutions available and ready for delivery. We are teaming with Sonora Quest to meet their increased testing volume requirements and will continue to build capacity to support broad-based testing globally,” said Masoud Toloue., Ph.D., Vice President & General Manager, Diagnostics, PerkinElmer. “We will begin live streaming our turnaround time for delivery of SARS-CoV-2 tests to increase transparency, allow testing centers to maintain maximum capacity, and enable labs to rapidly respond to evolving public health needs.”
Absolute Antibody is collaborating with University of Zurich to offer synthetic nanobodies against the receptor binding domain (RBD) of SARS-CoV-2. Under the partnership, the original nanobodies and newly engineered formats are now available to the global research community for use as serological controls and in COVID-19 therapeutic development. The synthetic nanobodies possess particular promise for the development of inhalable drugs, which could offer a convenient treatment option for the COVID-19 pandemic.
Nanobodies are small antibody fragments that can reach previously inaccessible parts of the body due to their compact size. Researchers are exploring their potential as inhalable COVID-19 drugs, which would be easier to administer and reach patients' lungs faster than other treatment formulations. The laboratory of Markus Seeger at University of Zurich developed a rapid in vitro selection platform to generate synthetic nanobodies, known as sybodies, against the receptor binding domain (RBD) of SARS-CoV-2. Within a two-week timeframe, the lab had identified more than 60 unique anti-RBD sybodies from combinatorial display libraries.
Further research showed that six of the sybodies bound SARS-CoV-2 spike protein with very high affinity, while five of those also inhibited ACE2, the host cell receptor to which SARS-CoV-2 binds to initiate the COVID-19 infection. Moreover, two of the sybodies can simultaneously bind the RBD, which could enable the construction of a polyvalent antiviral drug.
Absolute Antibody recombinantly produces the SARS-CoV-2 synthetic nanobodies for ensured batch-to-batch reproducibility, high purity, and low endotoxin levels. In addition, Absolute Antibody has used antibody engineering to fuse the nanobodies to Fc domains in different species, isotypes, and subtypes. For example, the anti-RBD binders are now available with human IgG1, IgG3, IgM, and IgA domains for use as serological controls. These recombinant engineered antibodies extend the applications of the sybodies by varying effector function and permitting increased half-life in in vivo studies.
Sanford Burnham Prebys Medical Discovery Institute entered into a research agreement with Eli Lilly and Company to characterize Lilly's anti-SARS-CoV-2 antibodies. These collaborative studies aim to build on Lilly's current portfolio of neutralizing antibodies by exploring novel cocktails, half-life extension technologies, and strategies to further enhance potency. Neutralizing antibodies have the potential for both prevention and treatment of COVID-19 and may be particularly important for groups hardest hit by the disease.
"We are very excited to be working with Lilly on this important project to help identify additional potential ways to treat SARS-CoV-2," says Sumit Chanda, Ph.D., director of the Immunity and Pathogenesis Program at Sanford Burnham Prebys. "Our scientists will be testing whether these antibodies can disrupt the interaction between SARS-CoV-2 and its human cell surface receptor, which will block the ability of the virus to attach and gain entry into our cells."
The research team will evaluate antibody candidates, delivered from Lilly through their partnership with AbCellera, using the live virus in the Institute's Biosafety Level 3 laboratory. The facility was established in 2016 to support Chanda's research on viruses having pandemic potential such as influenza, HIV, West Nile virus, Dengue fever and coronaviruses.
Taconic Biosciences entered into an exclusive agreement with the University of Texas Medical Branch at Galveston (UTMB) to distribute humanized ACE2 mice for coronavirus research.
Due to differences between the mouse and human ACE2 receptors, normal laboratory mice cannot be infected with SARS-CoV2. Transgenic mice that express the human ACE2 receptor overcome this challenge and are critical for COVID-19 research and treatments.
Dr. Chien-Te Kent Tseng and colleagues at UTMB generated humanized ACE2 mice as part of SARS-CoV research in 2007 and characterized them in several scientific publications. After discovering that ACE2 was the receptor for the virus that causes COVID-19, these old mice now had new value. Taconic is combining Dr. Tseng's models and expertise with decades of successful mouse model commercialization to bring this resource to COVID-19 researchers.
Scale up colonies is now underway. Mice will be available to both for-profit and non-profit researchers, with Taconic subsidizing distribution to the latter. The agreement also includes UTMB's humanized DPP4 mouse, implicated as a possible co-receptor for SARS-CoV-2.
ProMIS Neurosciences and BC Neuroimmunology Lab say they have created a highly accurate antibody test for SARS CoV-2. In validation testing, the serology assay achieved accuracy comparable to that of the industry leaders. Incorporation of ProMIS’ proprietary peptide antigens in the next phase of development is anticipated to support determination of whether or not antibodies detected in the serology assay possess virus neutralizing activity.
The antibody test the partners have developed is based on the use of surface plasmon resonance (SPR) technology, which offers considerable advantages compared to ELISA, the current standard for assay creation, including the possibility for high-volume testing.
The current version of the ProMIS-BCNI antibody test achieves 99.90% sensitivity and 99.50% specificity for SARS CoV-2, according to the partners. But the key step in development of a ‘best in class’ test is to create an assay that not only detects the presence of antibodies specific for the SARS CoV-2 virus but importantly, also allows to determine whether or not the detected antibodies have neutralizing activity, potentially conferring protection from COVID-19. As previously announced, using its unique technology platform ProMIS has identified 18 potential antibody targets (peptide antigens) that appear to be unique to the spike protein halo of SARS CoV-2. The next phase of assay development will involve testing to determine whether the antibodies that bind to one or more of these peptide antigens, as determined by SPR, are neutralizing antibodies.
“Starting next year, and throughout 2021 and beyond, we anticipate that billions of people will receive COVID-19 vaccines,” stated ProMIS executive chairman, Eugene Williams. “This is an unprecedented effort that showcases the capability and commitment of our industry. But it also means that billions of individuals will be vaccinated with very little information about the durability and variability of response to these new vaccines. We expect that vaccine companies worldwide and top research hospitals and government agencies will be looking for high volume, accurate, next generation serology tests with the ability to deliver more nuanced data regarding neutralizing antibodies. That is the rapidly emerging unmet need we are looking to serve as we progress development of our potentially ‘best in class’ SPR-based serology assay.”
Cobra Biologics signed a supply agreement with AstraZeneca to provide GMP manufacture of the adenovirus vector-based COVID-19 vaccine candidate AZD1222, previously known as ChAdOx1 n-CoV-19. The production agreement is part of AstraZeneca’s recently announced in-licensed program with the University of Oxford to ensure broad and equitable supply of the vaccine throughout the world, at no profit during the COVID-19 pandemic.
Cobra, along with other consortium members, expects to be manufacturing the vaccine with first deliveries to begin in the U.K. in September 2020.
The agreement is a further development of Cobra’s announcement in March 2020, that the Company is working as part of a consortium with the Jenner Institute, University of Oxford, and others, to rapidly develop, scale-up, and produce the recombinant adenovirus vector ChAdOx1 nCoV-19.
Proteintech Group has completed its ISO 13485 certification for medical devices. With this certification, the company’s HumanKine® Human cell-expressed cytokines and growth factors are now available in GMP-compliant versions for use in clinical trials and commercial manufacturing.
With the rise in clinical trials, there is not only a greater demand for GMP-compliant proteins, but also a demand for safer and more active proteins. Besides being xeno-free and free of animal-derived components, Proteintech’s HumanKine® Human cell-expressed proteins are produced with native folding, glycosylation, and processing. These properties result in higher efficacy and stability than proteins produced using other systems, according to the company
“The advances in cell and gene therapy and regenerative medicine have been astounding. As these therapies scale up, the need for quality reagents is more significant than ever,” explained Deepa Shankar, CSO. “By investing in a new GMP facility and the quality systems to ensure GMP-compliance and ISO 13485 certification, we at Proteintech aim to meet this demand with our suite of GMP grade Human-expressed, well-characterized bioactive proteins.”
Intravacc, a translational research and development vaccine institutes with an extensive track record in developing viral and bacterial vaccines, and EpiVax, a biotechnology company with expertise in developing vaccines and therapeutics, entered into a collaboration agreement to further progress a novel vaccine against COVID-19, based on Intravacc’s proprietary Outer Membrane Vesicles (OMV) technology platform.
For this joint research project, Intravacc will combine its immunogenic OMV delivery platform with synthetically produced COVID-19 epitopes, designed and optimized by EpiVax using advanced immunoinformatics tools, in order to generate a safe and highly effective T-cell response against SARS-CoV-2 and related coronaviruses. Preclinical studies will start immediately. Intravacc will utilize its in-house pilot-scale facility for the GMP production of the OMV-peptide vaccine, for phase I studies expecting to start in Q4 2020.
Novavax acquired Praha Vaccines in an all cash transaction of approximately $167 million. The acquisition includes a biologics manufacturing facility and associated assets in Bohumil, Czech Republic. The facility is expected to provide an annual capacity of over 1 billion doses of antigen starting in 2021 for NVX CoV2373, Novavax’ COVID-19 vaccine candidate. NVX CoV2373 consists of a stable, prefusion protein antigen made using its proprietary nanoparticle technology and includes Novavax’ proprietary Matrix M™ adjuvant.
“Manufacturing capacity is a critical component of our strategy to deliver a vaccine for the COVID-19 pandemic,” said Stanley C. Erck, President and CEO. “This acquisition provides the vital assets required to produce more than 1 billion doses per year. In parallel with ramping up production at Bohumil, we will continue efforts to expand antigen capacity in the U.S. and Asia, and increase production of Matrix-M to match antigen capacity at multiple sites globally.”
The acquisition includes a 150,000-square foot state of the art vaccine and biologics manufacturing facility and other support buildings, along with the existing employees and all related and required infrastructure. The facility is completing a renovation that includes Biosafety Level-3 (BSL-3) capabilities. As part of the transaction, approximately 150 employees with significant experience in vaccine manufacturing and support have joined Novavax.
The COVID Digital Pathology Repository (COVID-DPR), a virtual collection of high-resolution microscopic human tissue images from patients infected with COVID19, has been launched. Hosted at the National Institutes of Health, COVID-DPR provides a centralized, cloud-based reference data set for education, research, and future clinical trials. It contains digital whole slide images of lung, liver, kidney, and heart tissues from patients infected with COVID19, as well as the closely related coronaviruses associated with SARs and MERs.
COVID-DPR is underpinned by Indica Labs’ HALO Link™ software. The HALO Link instance associated with COVID-DPR will be deployed in a web portal developed and managed by Octo and Axle Informatics to provide a secure, globally accessible central repository. Biomedical scientists can securely add, view, annotate, analyze, and share whole slide images using HALO Link. Indica Labs’ image analysis, machine learning and artificial intelligence tools can also be integrated and accessed within the HALO Link interface.
The current initiative involves multiple institutes within NIH, and COVID-DPR will be available immediately as a shared resource for researchers at institutes around the world with initial data sets being provided by infectious disease labs across North America, Europe, and Australia. The repository is available at https://covid19pathology.nih.gov for those interested in accessing the whole slide images as well as those clinicians who have access to samples and data.
Color has received an emergency use authorization from the U.S. FDA to use LAMP technology for COVID-19 testing. The company is publishing its protocol for LAMP, or Loop-mediated isothermal amplification, for other labs to replicate.
LAMP is a molecular testing technology that delivers COVID-19 test results with accuracy equivalent to reverse transcription polymerase chain reaction (RT-PCR), but lends itself more readily to high-throughput automation and rapid lab scaleup.
Unlike RT-PCR, which amplifies viral genome segments through a method that requires multiple cycles of heating and cooling, LAMP takes place at a consistent temperature. Because of this, many of the steps in LAMP can be automated, cutting down the time it takes to process samples, according to Color. LAMP testing can happen 50 percent faster than RT-PCR testing for COVID-19 and requires a different set of chemical reagents, meaning that Color can avoid supply chain issues that have created backlogs for other test providers.
The Medicines for All Institute, based in the Virginia Commonwealth University College of Engineering, has joined forces with pharmaceutical industry leaders to ramp up manufacturing of vulnerable pharmaceuticals and their ingredients in the United States.
The U.S. Department of Health and Human Services has announced a $354 million, four-year contract with Phlow Corp. to accelerate this initiative.
Phlow Corp., a public benefit corporation focused on the research, development and manufacturing of essential pharmaceuticals, leads the partnership and will incorporate Medicines for All’s advanced manufacturing processes to produce active pharmaceutical ingredients for critical and short-supply medications. Civica Rx, a nonprofit pharmaceutical company and national supplier of affordable, generic medications, and AMPAC Fine Chemicals, with a Virginia-based pharmaceutical ingredient manufacturing operation, complete this new end-to-end pharmaceutical supply chain consortium.
Oxford Immunotec has released its T-SPOT Discovery SARS-CoV-2 test kit. This kit is for research use only and launched under the T-SPOT Discovery brand.
T-SPOT Discovery SARS-CoV-2 builds on Oxford Immunotec’s experience with TB diagnosis and the assessment of immune response to CMV in transplant patients to the fight against COVID-19. While serology is able to detect antibodies to SARS-CoV-2 in the blood of some individuals after infection, little is currently known about how this confers immunity to COVID-19. T-SPOT technology goes further than simple serology by interrogating the immune system’s T cell response and will enable research into the measurement of the strength of that response to SARS-CoV-2. The strength of this response may be linked to protection from reinfection.
According to Phill Keefe, SVP Product Design, Development and Delivery at Oxford Immunotec, “Not everyone with COVID-19 infection has detectable antibodies in serology tests, and this may be a bigger problem in the majority who experience only mild or no symptoms. Also, it is not yet clear whether the presence of antibodies confers immunity. T cell responses develop before antibody generation and can independently provide protection, so studying T cells could give us new insights into immunity to COVID-19.”
Thermo Fisher Scientific received a contract from the U.S. government to provide viral transport media (VTM) for COVID-19 sample collection. The VTM is used during collection of patient samples for proper transport to laboratories that can test for the presence of the virus.
To ensure accuracy of COVID-19 test results, VTM must be manufactured and dispensed into tubes in an aseptic environment. Thermo Fisher currently produces VTM at its site in Lenexa, Kansas, which meets this requirement, and has ramped production from 50,000 to more than one million VTM-filled tubes per week.
Thermo Fisher will expand capacity in Lenexa with a new $40 million facility dedicated to VTM production and quality control. The added capacity and increased efficiencies will allow the company to scale production to more than eight million VTM-filled tubes per week.
DefiniGEN says it has identified iPSC-derived intestinal organoids that could be used to help structure in vitro studies of the biology of SARS-CoV2 infection across cohorts of multiple patients. While SARS-CoV-2 primarily targets the respiratory system, studies have shown that it also infects and multiplies within the intestinal epithelium. IPSC-derived organoids exhibit characteristics that closely mimic the in vivo intestinal epithelium, making them a valuable surrogate model for studying the virus.
DefiniGEN iPSC-derived intestinal organoids display a polarized epithelium and harbor a mixture of cell types normally present in the primary intestinal epithelium barrier in vivo, including goblet cells, Paneth cells, enterocytes, LRG5+ stem cells, and enteroendocrine cells. The organoids polarise, form crypt structures, and grow villi at the apical surface, and are shown to secrete mucus in a similar manner to primary human gut tissue.
DefiniGEN’s differentiation platform is optimized to enable successful generation of intestinal organoids from a diverse range of patients. Patient skin fibroblasts or PBMCs can first be reprogrammed to iPSC, and then differentiated to produce mature intestinal organoids which carry the original patient genetics, and so manifest a gut model specific to that donor.
Zymo Research’s Quick SARS-CoV-2 rRT-PCR Kit has received Emergency Use Authorization (EUA) from the FDA. The kit is a qualitative test for the detection of nucleic acid from SARS-CoV-2 in upper and lower respiratory specimens taken from patients who are suspected of having COVID-19.
The EUA covers Zymo Research’s SARS-CoV-2 testing workflow, from specimen collection to purification, and virus detection. Specimen collection using Zymo Research’s DNA/RNA Shield™ allows biological samples to be transported and stored in a medium that preserves the genetic integrity of the sample. The Quick-DNA/RNA™ Viral MagBead Kit is designed for high-throughput purification of viral DNA and features a buffer system that facilitates complete viral particle lysis. High-complexity labs can use this inclusive workflow with manual or automated solutions.
Working in collaboration with WuXi Diagnostics and Mayo Clinic, Thermo Fisher Scientific is developing a total antibodies test. Thermo Fisher will seek U.S. FDA Emergency Use Authorization and international regulatory authorizations for the test over the next few weeks.
Once approved for use, the Thermo Scientific OmniPath COVID-19 Total Antibody ELISA test will detect Immunoglobulin M (IgM) and Immunoglobulin G (IgG) to help clinicians determine if a patient has been exposed to SARS-CoV-2. The test is designed to run on an open instrument platform, and the determination of antibody status will aid in the diagnosis of the disease during the acute and recovery stages of infection.
Thermo Fisher will begin manufacturing the Thermo Scientific OmniPath COVID-19 Total Antibody ELISA test at its sites in the U.S. and Europe in the next few weeks as it prepares to submit for EUA.
Brigham and Women’s Hospital researchers have developed a sensitive and specific serology test using Quanterix’ ultra-sensitive Simoa platform for the detection and measurement of anti-SARS-CoV-2 IgG, IgM, and IgA antibodies against four immunogenic viral proteins. Results from a recent study indicate that Simoa assays can detect seroconversion as soon as one day after symptom onset using less than a microliter of plasma.
The multiplex serological assay, which was licensed by Brigham and Women’s Hospital to Quanterix, has demonstrated the ability to detect antibodies against SARS-CoV-2 and identify individuals who have been infected with the virus but were asymptomatic or had mild symptoms. According to Quanterix, the Simoa assay has the potential to become a new standard by which researchers can conduct COVID-19 serological profiling and will be a valuable tool for answering important questions about the heterogeneity of clinical presentation seen in the ongoing pandemic. As such, Quanterix plans to explore the potential of transitioning the assay from its current laboratory research phase of development to a commercially available product.
Using a combination of IgG, IgM and IgA responses to spike protein, the research team used the serological assay to test 81 plasma samples from Massachusetts General Hospital to achieve a sensitivity of 86% and a specificity of 100% during the first week of infection when comparing COVID-19 positive patients to pre-pandemic controls. This sensitivity increased to 100% and the specificity remained at 100% for COVID-19 positive patients tested one week after symptom onset.
Mologic and BioSure have joined forces to produce a COVID-19 antibody self-test. According to the partners, their self test is easy to use, requires only a fraction of a drop of blood, and gives the user their result in just 10 minutes.
The BioSURE COVID-19 Antibody Self-Test will be ready for mass production at the beginning of June. It will be available to the UK and global markets and will also be available to be directly purchased by end-consumers. In addition, materials for all of Mologic’s COVID-19 diagnostics are being supplied to the Institut Pasteur de Dakar in Senegal which will manufacture tests for the African continent at their facility in Dakar.
The Chan Zuckerberg Initiative (CZI) has committed $750,000 in funding to support five projects studying how COVID-19 progresses in patients at the single-cell level. This work will generate single-cell biology datasets from donors infected by SARS-CoV2 and provide insights into how the virus infects humans, which cell types are involved, and how the disease progresses.
“Single-cell technologies provide a powerful platform for researchers to understand the cellular basis of any disease—including COVID-19,” said CZI Head of Science Cori Bargmann. “CZI’s support of the Human Cell Atlas has already enabled valuable insights into COVID-19—including identifying cells in the nose that may be entry points for the virus—and we’re proud to continue supporting this fundamental resource and increase our collective ability to address the coronavirus pandemic.”
The new grants will support projects led by investigators at Harvard Medical School, Massachusetts General Hospital, MIT’s Ragon Institute, the Broad Institute of MIT & Harvard, Columbia University, VIB-UGent, the Wellcome Sanger Institute, and the Josep Carreras Research Institute. All data generated by these grants will be made available to the scientific community via open access datasets and portals, including CZI’s cellxgene tool, which allows scientists to explore and visualize high dimensional single-cell transcriptomics datasets.
Eurofins Technologies reported the launch of its CE-IVD marked multiplex Real-Time RT-PCR assay for the direct qualitative pathogen detection of SARS-CoV-2.
The development of the assay has been spearheaded by affiliate companies Gold Standard Diagnostics, VIROTECH Diagnostics, and NovaTec Immundiagnostica. These diagnostic technologies companies have a strong focus on infectious diseases testing and have been collaborating closely with Eurofins scientists in the design and validation of the new product.
GSD NovaPrime® SARS-CoV-2 (COVID-19) simultaneously detects two target sequences inside the N gene. The multiplex PCR allows a streamlined workflow in one reaction and provides results in approximately two hours. An extraction/inhibition control and a positive control are included in the reagents.
According to the company, the PCR assay demonstrates excellent performance with a 100% negative and positive percent agreement for all tested samples and no cross-reactivity with other common widely spread coronaviruses. The analytic sensitivity shows a limit of detection of 3.75 copies/reaction.
As countries begin to ease restrictions and allow some businesses to reopen, contact tracing and epidemiological studies will be critical to understand resurgence of potential COVID-19 outbreaks. To expedite such analysis, Thermo Fisher Scientific has now optimized its Ion AmpliSeq SARS-CoV-2 Research Panel for the Ion Torrent Genexus System.
"The desire to get the global economy moving again responsibly is driving the need for advanced NGS technology that can quickly track the virus and enable health agencies to determine next steps," said Peter Silvester, senior vice president and president of Life Sciences Solutions at Thermo Fisher Scientific. "Access to rapid, simple and automated sequencing with the Genexus System can accelerate development of critical data to help stay ahead of COVID-19."
Thermo Fisher introduced the Genexus System in November. The platform's ease of use has been developed to provide all researchers access to the power of NGS technology. Its speed to results and automation is designed to accelerate a broad range of applications, including oncology, infectious disease and reproductive health, among others.
ZeptoMetrix® has launched a ready-to-use SARS-CoV-2 molecular quality control called NATtrol SARS-CoV-2 Positive Control. It is formulated with purified intact viral particles that have been chemically modified to render them non-infectious and refrigerator stable.
Complementing the release of the positive control is a negative control formulated with human A549 cells—NATtrol SARS-CoV-2 Negative Control.
"[W]e were tasked to develop and deploy reliable, user-friendly commercial solutions for ready-to-use, non-infectious SARS-CoV-2 full process molecular quality controls under accelerated timelines. Today, I am extremely proud to announce that ZeptoMetrix has launched such controls—containing purified intact viral particles of actual SARS-CoV-2 that provide laboratories, hospitals, and research facilities with essential external run controls to help ensure the reliability of COVID-19 testing", explains Shawn R. Smith, President & CEO.
ZeptoMetrix has also enhanced its coronavirus product line and has made it a priority to ensure product availability to diagnostic companies developing new and improved tests as well as those laboratories in hospitals and clinics seeking to ensure the reliability of the tests they perform.
Bio-Rad Laboratories’ SARS-CoV-2 Droplet Digital PCR (ddPCR) test kit has been granted Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration. The SARS-CoV-2 Droplet Digital PCR (ddPCR) test runs on Bio-Rad’s QX200 and QXDx ddPCR systems.
The company reports that the high sensitivity of the test makes it well suited to screening upper respiratory samples in patients with a low viral load, including individuals in the early stages of infection as compared to classical quantitative PCR tests. The test can also play an important role in surveillance by detecting minimal residual disease in people recovering from COVID-19 informing them if they are negative for the virus.
Thousands of hospitals and molecular testing labs in the U.S. and around the world have Bio-Rad’s QX200 and QXDx ddPCR systems installed and have the capacity to perform SARS-CoV-2 ddPCR testing. This is the second EUA Bio-Rad has been granted for COVID-19. Last week, the company received an EUA for a serology test to detect antibodies to the virus.
Arcturus Therapeutics, a clinical-stage mRNA medicines and vaccines company, and Catalent will work together to support the expected manufacture of Arcturus’ COVID-19 mRNA vaccine candidate (LUNAR-COV19), intended to protect against the SARS-CoV-2 coronavirus.
LUNAR-COV19 utilizes Arcturus’ self-transcribing and replicating mRNA (STARR™) technology and the Company’s LUNAR® lipid-mediated delivery to produce a low dose, potential single shot COVID-19 vaccine.
The manufacture of LUNAR-COV19 at Catalent’s drug substance biomanufacturing facility in Madison, Wisconsin, will support human clinical studies and, if successful, commercialization of the vaccine. The COVID-19 vaccine program will take advantage of the facility’s flex-suite, a cGMP manufacturing suite that can produce batches at multiple scales and support Arcturus’ proprietary mRNA manufacturing process.
The partners believe they can produce millions of doses of LUNAR-COV19 mRNA in 2020 and potentially 100s of millions of doses annually for worldwide use.
Bio-Rad Laboratories has been granted U.S. FDA Emergency Use Authorization (EUA) for its SARS-CoV-2 Total Ab test. The company reports that this is the first total antibody test receiving EUA from the FDA. Bio-Rad’s blood-based immunoassay test can help clinicians identify if an individual has developed antibodies against SARS-CoV-2. The test has also met the CE mark requirements for Europe.
Clinical evaluation of the SARS-CoV-2 Total Ab test has demonstrated diagnostic specificity of more than 99 percent and diagnostic sensitivity of 98 percent. Cross-reactivity testing demonstrated specificity of 100 percent with no reactivity against other interfering specimens including non-CoV-2 coronaviruses.
The SARS-CoV-2 Total Ab test can be used manually or on an automated immunoassay platform, such as Bio-Rad’s EVOLIS System, which offers high throughput processing and sample traceability.
Avacta Group, the developer of Affimer® biotherapeutics and reagents, and Adeptrix will work together to develop a high-throughput COVID-19 antigen test using Adeptrix’s bead-assisted mass spectrometry (BAMS™) platform.
According to the partners, Adeptrix’s BAMS platform combines enrichment of the sample to improve sensitivity with the power of mass-spectrometry to improve specificity. Hundreds of samples per day can be analyzed by a single technician using BAMS, exceeding the capacity of single PCR machine.
In addition to the BAMS platform, Avacta’s recently developed Affimer reagents that bind the SARS-COV-2 spike protein will be used to provide the capture and enrichment of the virus particle from the sample which could be saliva, nasopharyngeal swabs or serum.
The companies are aiming to have a BAMS test ready for clinical validation, regulatory approval and manufacturing in June. Adeptrix and Avacta are already in discussion with large-scale manufacturing partners to rapidly deploy this new high-throughput test.
Catalent announced a collaboration with the Janssen Pharmaceutical Companies of Johnson & Johnson, whereby Catalent’s Biologics business unit will prepare for large-scale commercial manufacturing of Johnson & Johnson’s lead vaccine candidate for COVID-19 at its facility in Bloomington, Indiana.
The collaboration commits joint investment to accelerate rapid scale-up of manufacturing capacity over the coming months to support production of the vaccine candidate. Catalent plans to hire approximately 300 additional employees at the site for this program starting in July 2020.
Catalent’s 875,000 square-foot facility in Bloomington has deep expertise in sterile formulation, with drug substance development and manufacturing and drug product fill/finish capacity across liquid and lyophilized vials, prefilled syringes, and cartridges as well as primary and secondary packaging. Scale-up in production will include the use of two new high-speed machines, including an Optima vial filling line and a Dividella NeoTOP® 1604 top-load cartoner.
ProteoGenix announced what it says is the first Human Immune COVID-19 library for the fast discovery of potent antibodies against SARS-CoV-2.
The library, created using blood samples from dozens of recovered COVID-19 patients, is adapted for screening with phage display and strives to meet the rising demands for effective antibodies for a broad range of applications.
The library’s diversity (1.2 x 1010 different clones) allied to the fast turnaround time and sensitivity of the screening technology, are intended to fast-track the discovery of antibodies with the strongest affinity, specificity, and viral blocking activity.
"Compared to the hybridoma technology, phage display saves time by allowing us to directly screen highly diverse and human antibody libraries. In addition, when developing therapeutic antibodies, this technique also helps us reduce the time-to-market by avoiding complex antibody humanization processes," says Raphaël Hopfner, Co-founder and CSO of ProteoGenix.
LabVantage Solutions reported the availability of its new purpose-built COVID-19 LIMS solution. The LIMS is designed to jump-start the ability of laboratories to enter biospecimens into a biobank and rapidly begin conducting COVID-19-related testing and research.
“At LabVantage, we mobilized our decades of expertise to rapidly deliver a new purpose-built Biobanking LIMS to support COVID-19 testing and research," CEO John Heiser explains. "It incorporates our deep knowledge of biobanking along with numerous features designed to make it easy for laboratories to acquire, implement, and use the most powerful LIMS on the market for their COVID-19 testing.”
The LabVantage COVID-19 Biobanking Accelerator is delivered as a SaaS solution, and the company says a go-live start is possible in less than four weeks. The LIMS Accelerator includes full biobanking capabilities and COVID-19 extraction and testing workflows with related master data for rapid use. It incorporates multiple protocols defined by the CDC for COVID-19 testing, and it can accommodate the addition of standard and customer-determined protocols for testing using a variety of approaches, such as RT-PCR, isothermal nucleic acid amplification, and serology.
Leinco Technologies inked an agreement with Vanderbilt University Medical Center (VUMC) to scale up production of its most promising antibodies for development of a rapid, point of care COVID-19 diagnostic test.
Under the agreement, Leinco Technologies will co-develop a rapid, point of care, immunodiagnostic test for the detection of the SARS-CoV-2 virus.
According to Pat Leinert Sr., President and CEO of Leinco Technologies, "It’s almost the perfect team to screen, develop and scale up manufacturing to provide our country with another badly needed weapon in the war against COVID-19. Leinco is in a unique position using its protein expression technology platform to rapidly scale up manufacturing of these antibodies from a DNA sequence to key components for a rapid, point of care COVID-19 diagnostic test kit. Finally, we will have a rapid point of care COVID-19 test kit that can be mass manufactured and sent to the front lines to track and trace this virus.
"We have been working non-stop since January to identify and characterize large panels of antibodies specific to SARS-CoV-2 virus. Obviously, one of the key utilities of these antibodies is for use in diagnostic screening. These type of screening approaches will be a critical piece of returning our society back to normalcy through tracking and understanding prior exposures to this specific virus," added Robert Carnahan, Ph.D., Associate Director of the Vanderbilt Vaccine Center.
MicroGenDX Laboratories, an established provider of PCR and NGS-based testing for microbial identification, has received FDA Emergency Use Authorization for its validated real-time Reverse Transcriptase PCR (rRT-PCR) assay for detecting the SARS- CoV-2 virus.
The test allows patients to self-collect sputum, but the EUA is also granted for the lab’s testing with NP swabs. However, because the lab sees greater potential for increased sputum and saliva testing, it is currently performing the requested paired sample analysis for its saliva-only test and anticipates FDA support on it in the near future.
MicroGenDX says it was one of the first national laboratories to validate and compare the testing of a variety of sample sources: sputum, saliva, and nasopharyngeal.
Three Oklahoma institutions, OU Medicine, the University of Oklahoma, and the Oklahoma Medical Research Foundation (OMRF), intend to use Fluidigm’s microfluidics technology and certain reagents to test individuals for the SARS CoV-2 virus. The test, developed by OMRF and OU Health Sciences Center scientists and utilizing the FluidigmBiomark™ HD system, is intended for large-scale testing of patients across the OU Medicine health care system. OU Medicine has applied for Emergency Use Authorization.
“Since the beginning of the COVID-19 outbreak, adequate resources for testing have been a serious challenge for health care systems around the world,” said Chris Linthwaite, President and CEO of Fluidigm. “Speed, scale and automation are critical components for delivering timely results. The Biomark HD platform can generate more than 6,000 individual test results per day with just one hour of hands-on time. A single system supports more than 2 million annual tests, and we are partnering with labs around the world to build out critically needed testing infrastructure.”
In a separate program, the Icahn School of Medicine at Mount Sinai and a group of other U.S. medical schools are developing a new epigenetic test for early COVID-19 detection designed for the Biomark HD, with the intent to seek EUA from the FDA.
Pharnext, a clinical-stage biopharmaceutical company developing drug combinations based on big genomic data and artificial intelligence (AI), and the University Hospital Institute (UHI) Méditérranée Infection forged a new joint effort dedicated to researching potential drug candidates for fighting COVID-19.
The joint activities will focus on rapidly testing in vitro a number of already approved drugs that were previously identified by Pharnext as potential candidates for fighting COVID-19 using its PLEOTHERAPYTM AI platform. The testing will also include several high priority drug combination candidates against the COVID-19 virus, also identified by Pharnext using its AI platform. The testing will be performed by the UHI Méditérranée Infection.
CytoSMART Technologies plans to donate 100 mini live-cell imaging systems to researchers in high containment labs worldwide. The company believes this initiative will help reduce the huge workload currently facing researchers on projects vital to combat COVID-19.
"We aim to do our part to assist researchers in minimizing the time they have to spend in high-contamination labs, by providing them with remote video access to evaluate the status of their cell cultures. The video data is used to remotely monitor the cytopathic effect, this way researchers know when it’s the right time to harvest the virus," CytoSMART CEO Joffry Maltha explains.
CytoSMART’s compact live-cell microscope films living cell cultures without disturbing their growth or behavior. The device operates from inside cell culture incubators and is accessible from an online environment. This enables researchers to analyze their cell cultures remotely and assess e.g. the cytopathic effect, which is caused by virus replication.
Laboratories can apply for a Lux2 live-cell imager here.
The FDA has permitted the use of LabCorp’s self-collection kits for COVID-19 testing under an emergency use authorization. Initially offered to healthcare workers and first responders, the Pixel by LabCorp kits will allow these front-line workers to collect nasal samples at home and send to LabCorp for analysis.
“LabCorp continues to develop new ways to help patients and healthcare providers fight the COVID-19 crisis through our leading testing capabilities and deep scientific and research expertise,” said Adam Schechter, president and CEO of LabCorp. “Our at-home collection kits are designed to make it easier and safer to test healthcare workers and first responders during this important time.”
LabCorp says it intends to make the COVID-19 self-collection kits available to consumers in the coming weeks.
Gnomegen has received Emergency Use Authorization from the US Food & Drug Administration for its real-time digital polymerase chain reaction (RT-Digital PCR Detection) diagnostic test for COVID-19.
Through an agreement with Gibraltar Brothers & Associates, Todos Medical now has access to the Gnomegen PCR Test Kits for its CLIA laboratory services business, as well as for distribution through Todos’ network.
Todos is currently validating Gnomegen’s PCR Test Kits in its partner CLIA lab (Provista) where it is also in validation for automated extraction machines to achieve High Throughput status with Centers for Medicare and Medicaid Services (CMS). Last week, CMS increased its payment rates for High-Throughput SARS-CoV-2 diagnostic tests that use high-throughput technologies allowing for increased capacity and faster results to $100 per test. A High-Throughput testing lab can process at least 200 specimens per day using “highly-sophisticated equipment that requires specially trained technicians and more more-intensive processes to assure quality,” according to CMS. Provista expects that it can scale up to a capacity of up to 2,000 PCR diagnostic tests per day in May 2020.
“We are very pleased to see Gnomegen’s PCR Test Kits achieve EUA status with the US FDA,” said Gerald Commissiong, President & CEO of Todos. “Gnomegen’s highly sensitive RT Digital PCR test kits are especially promising given the high sensitivity for RT digital PCR. This will be a great addition to our partner 3D Med’s automated extraction machine, which allows for significantly increased throughput over traditional lab workflows. We expect to begin offering PCR services in May to qualified customers with a view towards being a lab partner of choice for our antibody test kit customers who need confirmatory results.”
KorvaLabs and Curative partnered to develop the Curative-Korva SARS-CoV-2-Assay, which received FDA EUA late last week. The PCR-based test is designed to detect SARS-CoV-2 in respiratory specimens like nasal or oral swabs or oral fluid.
KorvaLabs, which was previously focused on anti-doping testing, says it can currently process 10,000 samples a day and is gearing up for more. It is providing testing to the City and County of Los Angeles as well as Long Beach, CA.
The Illumina SARS-CoV-2 Data Toolkit, a new suite of data analysis tools and workflow functionality for researchers working with the virus using next-generation sequencing, is now available at no cost to help combat COVID-19.
The toolkit integrates with Illumina’s installed base of 15,000 sequencing systems and is designed to help scientists track the path of the epidemic, understand transmission routes, determine the rate of viral evolution, and understand if the virus is changing in ways that impact therapeutic effectiveness.
“NGS is on the front lines in the fight against COVID-19 and Illumina is proud to provide technology and support to track transmission, conduct surveillance, develop therapies and vaccines, and ensure long-term global safety and security,” said Senior Vice President and Chief Medical Officer, Dr. Phil Febbo. “By design, these tools are applicable beyond COVID-19 to begin to build global capabilities for proactive surveillance of future outbreaks.”
The toolkit includes a new DRAGEN RNA Pathogen Detection Pipeline to enable detection of infectious diseases, as well as a DRAGEN Metagenomics Pipeline for outbreak surveillance, an SRA Import App, as well as a GISAID Sharing App.
Once analysis is complete, researchers can submit their data to public databases directly from BaseSpace Sequence Hub. Illumina is offering the new toolkit to the community on BaseSpace Sequence Hub, free of charge, until October 2020.
Scientists at UC San Francisco and Mammoth Biosciences have developed a CRISPR-based test that can rapidly diagnose COVID-19 infections. UCSF researchers are now working to clinically validate the SARS-CoV-2 DETECTR, which is described in a paper published today in Nature Biotechnology, in order to obtain Emergency Use Authorization from the FDA.
The SARS-CoV-2 DETECTR assay is among the first to use CRISPR gene-targeting technology to test for the presence of the novel coronavirus. Since CRISPR can be modified to target any genetic sequence, the test kit’s developers “programmed” it to home in on two target regions in the genome of the novel coronavirus. One of these sequences is common to all SARS-like coronaviruses, while the other is unique to SARS-CoV-2. Testing for the presence of both sequences allows the DETECTR tool to distinguish between SARS-CoV-2 and closely related viruses.
According to the developers, advantages of the DETECTR test include fast turnaround of results and use of off-the-shelf reagents and common equipment. The test is also highly sensitive; it can detect the presence of as few as 10 coronaviruses in a microliter of fluid taken from a patient. Though slightly less sensitive than existing PCR-based tests, which can detect as few as 3.2 copies of the virus per microliter, the difference is unlikely to have a noticeable impact in diagnosis, as infected patients typically have much higher viral loads.
On Wednesday, Chembio Diagnostics received Emergency Use Authorization (EUA) for its DPP COVID-19 System. The DPP COVID-19 System is a serological point-of-care test and analyzer that provides numerical readings for both IgM and IgG levels within 15 minutes from a finger stick drop of blood.
“We are very pleased with the continued progress our teams are making to address the market demands with our DPP COVID-19 serological system,” stated Rick Eberly, Chembio’s CEO. “The flexibility of having two analyzers and a system that provides high sensitivity and specificity that is generally consistent with the performance of Chembio’s other DPP platform tests as part of our offering places us in a unique position to serve a variety of markets. Additionally, we are pleased to announce that our manufacturing team has produced and shipped our first lots of the COVID-19 Systems, and we look forward to providing further product within the US and abroad.”
HALIX has joined a consortium to provide GMP manufacturing services to support the large-scale production of a COVID-19 vaccine (ChAdOx1 nCoV-19) being developed by the University of Oxford’s Jenner Institute.
The nCoV-19 vaccine is based on the Jenner Institute’s adenovirus vaccine vector (ChAdOx1) technology, which was chosen as the most suitable candidate for a SARS-CoV-2 vaccine as it can generate a strong single dose immune response, and is not a replicating virus, so it cannot cause infection in the vaccinated individual.
Under the collaboration, HALIX will utilize its state-of-the-art GMP facilities with capacity up to 1,000 L SUB scale, applying its viral vector bioprocessing expertise to transfer an industrial-scale drug substance process from Pall in the UK, supporting the manufacture of ChAdOx1 nCoV-19 clinical trial material. Based on this transfer, HALIX and the consortium will be in a position to manufacture at a larger scale.
HALIX has an established track record for the development and GMP manufacture of viral vectors used against infectious diseases, such as HIV, ZIKA, chikungunya and the flu. Its 6,700 m2 BSL2 GMP facility, located in Leiden, provides both clinical and commercial scale manufacturing capabilities in fully independent, self-contained Grade B and C cleanrooms for virus products.
In order to facilitate rapid access to its cGMP-compliant CHOSOURCE™ platform for the development or production of therapeutic proteins, diagnostic assay components, or vaccines relating to COVID-19, Horizon Discovery Group today announced special commercial licensing terms.
The CHOSOURCE platform includes a gene-edited Glutamine Synthetase (GS) knockout Chinese Hamster Ovary (CHO) K1 cell line, a well-established GS expression system suitable for high yield biomanufacturing. The platform is already offered as a royalty-free alternative for the production of complex proteins and is used by early stage start-ups to large pharmaceutical companies to drive efficiencies throughout development and production.
“The current coronavirus crisis is highlighting existing shortcomings in the development of much-needed therapeutics,” Jesús Zurdo, Global Head Bioprocessing, explained. “Horizon Discovery is fully committed to help innovators in their efforts to develop new solutions to tackle the COVID-19 pandemic. We are providing immediate access to our state-of-the-art bioproduction platform under very favorable terms to facilitate such efforts.”
Rutgers’ RUCDR Infinite Biologics obtained emergency use authorization from the U.S. FDA for its new collection approach that utilizes saliva as the primary test biomaterial for the SARS-CoV-2 coronavirus.
The new saliva collection method, which RUCDR developed in partnership with Spectrum Solutions and Accurate Diagnostic Labs, will allow for broader population screening than the current method of nose and throat swabs, according to the collaborators.
“The impact of this approval is significant,” said Andrew Brooks, COO and director of technology development at RUCDR. “It means we no longer have to put health care professionals at risk for infection by performing nasopharyngeal or oropharyngeal collections. We can preserve precious personal protective equipment for use in patient care instead of testing. We can significantly increase the number of people tested each and every day as self-collection of saliva is more quick and scalable than swab collections.”
The FDA’s approval of the new saliva testing approach is the second major announcement in recent days from RUCDR, which launched a genetic testing service for the coronavirus that can test thousands of samples daily. With the new saliva test, that number may increase to tens of thousands of samples daily.
Bruker has partnered with the Australian National Phenome Centre (ANPC) at Murdoch University to support the work of their researchers into COVID-19. The ANPC team, led by Professor Jeremy Nicholson, has launched a major research and diagnostics project to better understand and predict variation in COVID-19 severity and determine the complex genetic, environmental and lifestyle interactions that influence its pathogenicity in individuals.
The initiative will focus on the metabolic biomarker patterns of diseases, prognosis and treatment response. In addition, the risk of severity of infected patients needs to be assessed rapidly to help guide and optimize the clinical patient pathway. Researchers at the ANPC will use instrumentation from Bruker, as well as data modeling approaches, to perform broad and deep metabolic analysis of the molecular, physical and biochemical characteristics of blood plasma and urine samples to create informative translational models. These models will predict variation in the severity of the disease and help understand differential responses to therapeutic interventions.
“At the ANPC, we are dedicating 100% of our resources to the COVID-19 fight for at least a year,” Professor Nicholson said. “This is the greatest emergent healthcare challenge on the planet and there is no better equipped metabolic lab in Australia, or possibly anywhere in the world, to undertake this type of investigative work in an excellent clinical and hospital framework.”
BillionToOne reported earlier this week that it has developed a highly accurate and cost-effective Sanger sequencing based COVID-19 test protocol that could help enable a testing capacity of one million tests per day. Test reagents will be available in two weeks, pending manufacturing of kits and EUA from the FDA.
According to Oguzhan Atay, CEO of BillionToOne, current quantitative PCR (qPCR) methods do not support the testing volume needed for rapid COVID-19 response. Additionally, the extreme surge in demand for the same reagents and instruments have caused multiple bottlenecks in the supply chain.
Using the patent-pending qSanger™ spike-in and proprietary machine learning algorithms, BillionToOne’s COVID-19 assay takes advantage of the 30X higher throughput Sanger sequencing capacity (1,536 samples on qSanger at a time vs 48 samples on qPCR at a time). qSanger technology unlocks each Sanger instrument to automatically perform 3,840 tests per day.
The BillionToOne COVID-19 test uses different sets of instruments and chemicals from existing COVID-19 tests, enabling labs to unlock a new set of unused capacity. BillionToOne sequences the virus' genome, making the test extremely sensitive and specific, Atay explains. Additionally, the test is easily adoptable at any labs with Sanger Sequencers, with minimum training, he says.
Yesterday, PHASE Scientific announced the launch of its PHASIFY VIRAL RNA Extraction Kit. PHASIFY VIRAL purifies and concentrates viral RNA in patient samples.
According to the company, its technology outperforms conventional solid phase extraction methods in RNA yield and concentration. Conventional solid phase extraction technologies have performance limitations that result in poor sample quality. The concentration of SARS-CoV-2 RNA in patients' (especially early stage) samples is relatively low, inducing low PCR detection sensitivity, high false negatives occurrences, and necessity for repeated confirmation testing. PHASIFY concentrates target molecules by 10–100x, making them easier to detect.
PHASIFY VIRAL kit, which incorporates the PHASIFY liquid phase extraction technology, produces greater viral RNA yields. This is enabled by an increased sample input volume up to 1 mL per extraction, and enhanced final viral RNA concentration with flexible elution volume down to 10 µL. Its easy-to-use design requires no additional specialized equipment such as magnetic racks and vacuum pumps for operation.
Cytel has launched an open-access global COVID-19 Clinical Trial Tracker.
Funded in part by The Bill and Melinda Gates Foundation, this live dashboard offers an overview of all the trials taking place in the international effort to tackle the pandemic. One of the most difficult challenges facing those seeking a COVID-19 treatment is how little data exists about this disease. Early investigators are relying on guesswork to determine which therapies to investigate. Collating information in one place on the growing numbers of trials, will enable decision-makers to compare treatments more easily as they determine which to investigate further.
In addition, without a dashboard, scientists and other stakeholders would have to examine hundreds of different trial registries for updates, to determine which are most promising. The dashboard collates these in one place making it easy to see all the relevant trials and to compare the effectiveness of treatments. Such comparisons will also help foster more transparent debates about reasonable cost-benefit analysis during times when tough calls are required about where to direct resources.
By creating this dashboard to facilitate the sharing of crucial information, Cytel aims to encourage further collaboration between scientific, philanthropic and policy-making stakeholders around the world while also informing journalists, policy makers and local government about options for testing in their area.
Dolomite Microfluidics and Mologic are collaborating to accelerate the development and launch of rapid and reliable point-of-need COVID-19 diagnostic tests.
Mologic is already a leading developer of rapid response diagnostic tests for diseases such as malaria and Ebola virus disease, areas in which it has been leveraging its core technology to develop ultra-sensitive point-of-care diagnostics that are easy to use and inexpensive to manufacture.
Precisely manufactured nanoparticles are integral to Mologic’s diagnostics, which is where Dolomite comes in. The company specializes in equipment that allows the development and scale-up of precision nanoparticles by using microfluidic technology to retain advanced control of production conditions.
Working together, the companies aim to speed the validation and release of Mologic’s COVID-19 diagnostic test.
Avacta Group, the developer of Affimer® biotherapeutics and reagents, has joined forces with Cytiva, formerly known as GE Healthcare Life Sciences, to develop and manufacture an Affimer-based point-of-care rapid test to diagnose COVID-19 infection.
The WHO recently highlighted the need for the development of rapid tests to quickly diagnose COVID-19 at point-of-care as existing tests are not suitable for screening large numbers of people rapidly.
Avacta is already generating Affimer reagents that detect the COVID-19 virus and together with Cytiva will develop and manufacture a test capable of diagnosing the infection in minutes using a respiratory sample such as saliva. Cytiva will transfer this diagnostic assay onto its proprietary point-of-care test strip platform and both companies will work together to complete analytical and clinical validation of the test as quickly as possible.
Avacta will own the intellectual property relating to the COVID-19 Affimer-reagents and will retain all the commercial rights to future products.
According to Dr Alastair Smith, CEO of Avacta Group, “We have demonstrated before in the case of the Zika virus that the Affimer platform can very quickly provide highly specific reagents in response to an outbreak of an infectious disease. Our partnership with Cytiva means that we now have a global technology partner for a COVID-19 diagnostic, which is essential if a practical and commercial solution is to be provided to governments and healthcare providers around the world promptly.”
MicroGenDX Laboratories has validated a real-time Reverse Transcriptase PCR (rRT-PCR) assay for the detection of the SARS- CoV-2 virus. The company says it is the first national laboratory to offer validated COVID-19 testing using saliva and sputum samples.
“We looked at the data regarding viral detection rates with various sample types,” explains MicroGenDX CEO, Rick Martin. “A saliva or sputum sample has a higher detection rate than nasal swabs, and we are confident our test is sensitive enough to detect COV19 in sputum, even if the patient does not have a productive cough.”
MicroGenDX runs its COVID-19 Rapid PCR Test at its diagnostic laboratory in Lubbock Texas with a 24-hour turnaround from time of sample receipt. The laboratory has begun running tests at a capacity of 5,000 COVID-19 samples a day and plans to increase that number to 10,000 per day in the near future.
BGI and Etopia have designed a mobile, inflatable P2 level biosafety laboratory called the Huo-Yan Air Lab. The first was installed at the Shenzhen National GeneBank last week.
The Huo-Yan Air Lab’s design uses a modular air dome structure. It can be transported by air on a commercial passenger plane and quickly constructed and deployed to support screening and detection capabilities. Huo-Yan is based on BGI’s previous experience constructing a P3 level biosafety laboratory using an inflatable structure during the Ebola outbreak in 2014 in West Africa.
The Huo-Yan Air Lab consists of five major areas for sample collection, sample reception, sample preparation, reagent preparation, and amplification. It is equipped with auxiliary conversion space including air lock conversion, medical waste exhaust system and integrated bathroom, and is installed with Class II biological safety cabinets, automatic nucleic acid preparation instruments, qPCR instruments, antibody detection equipment, gene sequencers, high-performance servers, and other COVID-19 virus nucleic acid detection equipment.
Cytiva, formerly known as GE Healthcare Life Sciences, is developing an affinity resin and providing technology and services to support University of Queensland scientists who have a COVID-19 vaccine in preclinical testing and are gearing up for clinical trials.
Cytiva’s role will include supporting the manufacture of the vaccine at CSIRO, creating an affinity resin prototype for vaccine purification, and supporting scale up with planning underway for phase II material manufacturing.
UQ’s molecular clamp technology forms the basis of the vaccine platform. Their COVID-19 vaccine candidate targets the virus’ spike protein and is designed to lock this protein in its native shape, allowing the human immune system to be able to recognize and then neutralize the virus. Developing a specific protoype affinity resin for a vaccine candidate is an important step in developing the material for clinical trials as well as preparing scale up equipment for future mass production.
Luminex received Emergency Use Authorization for its ARIES® SARS-CoV-2 Assay for rapid detection of the virus. The assay runs on the ARIES® System, an FDA-cleared, sample-to-answer, automated, on-demand molecular diagnostic platform. The system is capable of running up to 144 tests per day, requiring no specialty training and minimal human interaction.
"The ARIES® SARS-CoV-2 Assay will allow hospital professionals to determine the appropriate course of treatment for patients suspected of having COVID-19 within approximately two hours," said Nachum "Homi" Shamir, President and CEO of Luminex.
The company is scaling up production of this assay over the next three weeks to support hundreds of labs across the U.S. and the rest of the globe. These labs are already operating the ARIES® System and "should be able to get up and running very quickly as we make this test broadly available," according to Shamir.
BioData has introduced new video conferencing service in its Labguru ELN platform and offered it free of charge for all customers to support remote working. The new LabRoom tool facilitates live global collaboration, experiment planning and tracking, as well as data collation and analysis, all within the Labguru electronic web notebook.
“As a software provider to the world’s science community, we are well placed to support remote working and global scientific collaboration. We hope that launching this new service at this time for all our customers, completely free of charge, goes some way towards supporting researchers working across the globe to combat this crisis,” Jonathan Gross, founder and CTO of BioData, explained.
A key feature of LabRoom is its ability to work within the Labguru ELN platform, capturing all the data tracking, management and analysis capabilities within the application. Its features include one-click video chat, video data encryption, real time delegate availability indication, screen sharing via Google Chrome, a session recording option, and instant access, with no need to download, verify or install new software.
In a first for the U.S., Cellex received FDA approval for its blood test to detect coronavirus antibodies.
The qSARS-CoV-2-IgG/IgM Rapid Test detects IgM and IgG antibodies against SARS-CoV-2 in serum, plasma, or venipuncture whole blood. It is not intended to be used as the sole basis for diagnosis, according to the FDA.
Positive results for both IgG and IgM could occur after infection and be indicative of recent infection. The test reportedly provides results in about 15 minutes.