We are all just a handshake, sneeze, insect bite, or contaminated salad away from contracting an infectious disease. Fortunately, most infections are relatively benign with short-term symptoms (if any); however, others do progress to active diseases that are more debilitating or even life threatening. As a result, considerable money and effort has been invested into scientifically combatting infectious diseases for at least a century.
In 2019, the NIH estimates that it will spend over $6 billion on infectious disease–related research. The NIH’s investment includes funds for studying emerging infectious diseases like the Heartland and Bourbon viruses, so far only found in the midwest and in the southern United States, as well as re-emerging diseases like tuberculosis.
Many philanthropic organizations, like the Bill & Melinda Gates Foundation, have also invested heavily in infectious disease research and treatment. To date, the organization has committed more than $3 billion to help the almost 40 million people around the globe who have human immunodeficiency virus (HIV). Among its partners is Medicines for All (M4ALL), founded in 2014 by Frank Gupton, a former pharmaceutical process development scientist. M4ALL, which operates as a research institute within the Virginia Commonwealth University (VCU) College of Engineering, is focused on optimizing pharmaceutical manufacturing by developing cost-effective techniques to synthesize active pharmaceutical ingredients as well as designing continuous manufacturing operations.
Improving drug manufacturing processes
In February, M4ALL developed a more efficient way to synthesize 5-fluorocytosine (5FC), a major ingredient of emtricitabine, a first-line therapy used in the treatment of HIV/AIDS. The cost of 5FC, which currently requires special manufacturing facilities, has been skyrocketing. According to M4ALL, the new approach could be behind a recent 35% reduction in the cost of the drug.
Last year, VCU formed a three-year partnership with the Ivory Coast to train researchers from the West African country in pharmaceutical manufacturing as well as to help the government develop a drug research facility. The goal is for the Ivory Coast to be able to produce high-quality HIV drugs for its citizens.
Sample processing for diagnostic tests
Ceres Nanosciences is advancing the development of infectious disease diagnostics that use noninvasive sample types. The company’s Nanotrap® particle technology was developed at George Mason University and has been incorporated into many infectious disease diagnostics to improve sample processing and downstream assay sensitivity.
According to Ross Dunlap, CEO, the novel analyte-harvesting nanotechnology improves the fractionation, concentration, and preservation of low abundance proteins, peptides, nucleic acids, small molecules, whole virus, bacteria, exosomes, and other analytes from complex biofluid matrices. For example, use of Nanotrap® technology in an infectious disease test allows for a large-volume urine sample to be processed in order to capture the disease analyte at the earliest stages of infection and make it available for detection on multiple downstream assays. The analyte is present at such low levels that it is undetectable without using the Nanotrap technology, Dunlap explains.
Ceres has partnered with a number of organizations to apply its Nanotrap technology in pressing need areas. Partners include the Bill and Melinda Gates Foundation (Ebola and tuberculosis applications), DOD (infectious disease outbreaks), and DARPA (Zika and other febrile illnesses).
Pathogen detection
Although methods for detection of pathogens have improved over the years, standard testing can still miss many infections. Aperiomics, which launched in 2014 in Virginia, has set its sights on identifying every known bacterium, virus, parasite, and fungus through deep shotgun metagenomic sequencing in a quest to improve pathogen detection. The company’s bioanalytical software, called Xplore-PATHO, was created to make sense of all the data it has amassed.
While the Aperiomics technology could be used as a first line of defense, the company has positioned its services as the second line of defense when a patient exhibits chronic and recurring infections, according to CEO Dr. Crystal Icenhour.
In order to use the Aperiomics service, a patient who is suffering from a chronic or recurrent infection must have their clinician collect their sample then send it to the Aperiomics’ lab. The company offers 11 different collection kits, including for urine, fecal, CSF, and breast milk samples, and also recommendations on when to use each collection kit (fecal, for example, is recommended for primary symptoms associated with the lower GI tract).
Once collected, the patient’s doctor assumes responsibility for submitting the sample to Aperiomics, and 10 to 14 days later, the Aperiomics report will be sent to the clinician. The doctor can also request a consultation with one of the company’s infectious disease experts to walk through the report and understand what may be causing the patient’s infection.
The success stories on Aperiomics’s website include patients, young and old, who suffered months or years with undiagnosed conditions prior to the cause of their symptoms being identified with Aperiomics’s technology.
With new infectious diseases emerging regularly, old ones reemerging, and antibiotic resistance spreading rapidly, innovative approaches to diagnosis and treatment, like the ones developed by these Virginia-based organizations, are essential to combatting these pervasive diseases.