FDA Clears Test Developed In Partnership With VCU Researcher

Source : Virginia Commonwealth University

The Food and Drug Administration has approved a new test to help physicians diagnose a group of rare cell disorders. The test, or assay, was developed by an expert at Virginia Commonwealth University in the field of mast cells.

Lawrence Schwartz, M.D., Ph.D., chair of the Division of Rheumatology, Allergy and Immunology and the Charles and Evelyn Thomas Professor of Medicine at VCU, has spent more than 30 years researching mast cells. These cells are vital to the inflammatory process within the body and may play protective roles in wound healing and fighting infections.

“When a mast cell is triggered, it releases several strong chemicals into the body, including histamine and tryptase. Histamine causes itching, swelling, wheezing and sneezing and other signs and symptoms of allergic reactions,” said Schwartz.

Mastocytosis, a group of rare chronic disorders found in both children and adults, is caused by the presence of too many of these mast cells in the body. If there are too many mast cells, the increased burden of chemicals released from these cells can cause several symptoms that range in intensity from mild to severe.

Because mast cells play a role in allergic reactions, the symptoms of mastocytosis are often similar to an allergic reaction. However, mastocytosis may occur spontaneously rather than be triggered by an allergen.

The FDA has cleared ImmunoCAP Tryptase, a new diagnostic assay, to measure the level of tryptase in the blood as an aid in the diagnosis of systematic mastocytosis. A persistently elevated baseline level of tryptase is an indication of possible mastocytosis.

“A physician cannot diagnose systematic mastocytosis based only on a physical examination. The FDA approval of the tryptase assay will provide doctors with an additional diagnostic tool,” said Schwartz.

VCU first licensed the assay in 1993 to Pharmacia, now named Thermo Fisher Scientific Inc. The assay has one FDA-approved application – helping to diagnose mastocytosis – and several potential applications, including the diagnosis of systemic anaphylaxis, the prediction of increased risk for future episodes of severe anaphylaxis and use by medical examiners to evaluate cause of death.

“When somebody dies without a clear cause, by measuring postmortem tryptase levels, an increased level of tryptase provides support for an anaphylactic event near the time of death,” said Schwartz.

About VCU and the VCU Medical Center

Virginia Commonwealth University is a major, urban public research university with national and international rankings in sponsored research. Located on two downtown campuses in Richmond, VCU enrolls more than 32,000 students in 211 certificate and degree programs in the arts, sciences and humanities. Sixty-nine of the programs are unique in Virginia, many of them crossing the disciplines of VCU’s 13 schools and one college. MCV Hospitals and the health sciences schools of Virginia Commonwealth University compose the VCU Medical Center, one of the nation’s leading academic medical centers. For more, see www.vcu.edu.

  • <<
  • >>

Articles List

  • Add a Molecular Dimension to Your Tissue Slices with Imaging Mass Spectrometry

    Add a Molecular Dimension to Your Tissue Slices with Imaging Mass Spectrometry

    Imaging Mass Spectrometry scans a tissue section point by point, amassing a dataset that correlates molecular species with their spatial positions. The images are sharper than ever. What’s changed is the maximum possible pixel resolution of the images researchers can take, and the variety of spectral “cameras” that can be used to generate them.
  • Squeeze More Data from Your Sample with Multiplexed qPCR

    Squeeze More Data from Your Sample with Multiplexed qPCR

    Multiplex qPCR commonly used for SNP detection, gene expression and other applications for which a large number of samples, or precious samples, need to be screened for a small number of targets. But multiplex qPCR isn’t as simple as it sounds, with the complexity of designing and validating the assay increasing with each new target.

Disqus Comments