Device Detects Bacterial Contaminants in Platelets

An estimated 10 million platelet units are transfused each year into patients in North America, Europe, and Asia, and experts estimate that as many as one in every 2,000 units could be contaminated with bacteria.

To combat the risk of bacterial contamination, the American Association of Blood Banks (AABB; Bethesda, MD, USA) requires all of its members to detect and limit contamination in platelets. Current culture testing methods miss at least half of all bacterial contaminations and take up to three days before results are available. In comparison, the Verax Platelet PGD Test is designed to produce results in less than 30 minutes, and targets all species of bacteria known to cause diseases in humans.

Verax Biomedical Inc., (Worcester, MA, USA), a leading developer of rapid tests for detecting bacterial contaminants in blood cells and tissue, has submitted a 510 (k) application to the U.S. Food and Drug Administration (FDA) for its platelet PGD test. This filing is based on data gathered at three major U.S. hospitals and is intended to demonstrate that the performance of the product is substantially equivalent to existing FDA cleared tests for the detection of bacterial contamination in platelets. FDA clearance of the test would permit Verax to market the device.

The filing comes in advance of anticipated strong worldwide demand for the Verax Platelet PGD test. Recently, Abbott Diagnostics signed a worldwide exclusive agreement to market and distribute the product, and British Biocell International (BBI) signed a 10-year contract to provide gold colloid and manufacturing.

The Verax PGD test is based on Verax Biomedical's proprietary Pan Genera detection technology, which targets common antigens found on the surface of all species of bacteria known to be pathogenic to humans.

We get calls everyday from blood banks and hospitals eager to add our Platelet PGD Test to their protocols, said Jim Lousararian, CEO of Verax Biomedical. The 510 (k) filing brings us one step closer to marketing this product, and allowing clinicians to use it to ensure safer blood products.


Related Links:
AABB
Verax Biomedical