Bacterial Detection Test from Verax Cleared for Market
In addition to the recent FDA approval, Verax Biomedical, Incorporated received the CE mark for its Platelet PGD Test. The diagnostic system is utilized to detect bacterial contaminants in either tissue or blood cells. Such contamination is the prime cause of mortality in patients who received platelet transfusion.
The Platelet PGD Test is a disposable, single use device that is easy to use. This test detects the presence of bacterial contaminants at a later phase in the life cycle of the platelet, an improvement compared to existing methods.
Data collected indicates that the test is able to detect a range of bacterial contaminants in buffy coat platelets. Most of the tests completed were in the U.S., where extensive validation studies were undertaken.
One particular benefit of the Platelet PGD test is the reduced cost with this testing method. Traditional approaches require complex pathogen reduction methods, which are frequently costly. Another downside of ceonventional approaches is increased risk to the platelets themselves.
According to the company, the test will improve the overall safety of the blood supply by identifying bacterial contaminants. Estimates suggest that approximately 1 in 2,000 platelet specimens have bacterial contamination. Availability of this test allows identification of such so that they can be discarded.
September 30, 2008 Related topics: Laboratory, Product Approval & Certification, Diagnostic, Hematology & Oncology