Fenwal Signs Agreement to Improve Transfusion Safety

Fenwal Inc. (Lake Zurich, IL, USA), a company focused on improving blood collection, separation, safety, and availability signed a five-year exclusive worldwide agreement with Verax Biomedical Inc. (Worcester, MA, USA) to market, sell, and distribute Verax's PanGenera Detection (PGD) technology.

The Verax PGD test, a rapid immunoassay, targets antigens found on the surface of a wide spectrum of common bacteria that are pathogenic to humans in high concentrations. The immunoassay consists of an easy-to-use disposable handheld device and reagents that work together to detect the presence of bacterial contaminants in platelets. The test is performed in less than 30 min. and can be used in hospitals, cancer centers, and other sites of care, as a safeguard immediately prior to transfusion.

An estimated 1 in 2,000 to 3,000 platelet units could contain bacteria, and up to 50 % of bacteria-contaminated platelets can escape detection by conventional culture testing. Bacteria can cause fatal reactions, especially in immune-compromised patients. The Verax PGD immunoassay detects bacteria in leukocyte-reduced apheresis platelets as an adjunct quality-control test following previous bacterial testing.

Verax is developing more PGD technology diagnostic tests to detect bacteria in other blood components, tissues for transplantation, and cell-based therapies. Meanwhile the technology has been cleared by the United States Food and Drug Administration (FDA; Silver Spring, MD, USA) and received the CE marking in Europe.

More than 5 million platelet doses are transfused annually worldwide. Platelets are cells in blood that help blood clot. They are transfused when platelets levels are low--as, for example, a result of illness or the adverse effect of some chemotherapy treatments.

Darrell J. Triulzi, M.D., medical director of the Institute for Transfusion Medicine and the University of Pittsburgh Medical Center's Division of Transfusion Medicine, (UPMC; Pittsburgh, PA, USA) said, "The blood center community has made progress with the implementation of culture-based tests, but these occur at the point of collection when bacteria levels can be too low for detection. A rapid, point-of-care assay, such as the Verax PGD test, takes place just prior to transfusion, which is the best time to detect bacteria levels in platelets and provides a more comprehensive strategy for patient safety."

Related Links:
Fenwal Inc.
Verax Biomedical Inc.
United States Food and Drug Administration
University of Pittsburgh Medical Center