Verax Biomedical Inc., 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, which cuts the detection time for bacterial contamination to
approximately 30 minutes compared to the one- to three-day detection times
of currently available tests.
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 Platelet PGD Test is an easy-to-use, disposable device designed to
detect the presence of a broad range of bacterial contaminants in platelets
prior to transfusion. Bacterial contamination in platelets and red blood
cells represents the single greatest risk for lethal infections in
transfusion medicine today. 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 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.
“We get calls everyday from blood banks and hospitals eager to add our
Platelet PGD Test to their protocols,” said Jim Lousararian, chief
executive officer 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.”
The Verax PGD Test is based on Verax Biomedical’s proprietary Pan
Genera(R) Detection technology, which targets common antigens found on the
surface of all species of bacteria known to be pathogenic to humans.
About Verax Biomedical, Inc.
Based in Worcester, Mass., Verax Biomedical is a leader in the
development of rapid tests designed to detect a broad range of bacterial
contaminants based upon its proprietary Pan Genera Detection (PGD)
technology. The first target application for its technology is to test for
the presence of bacterial contaminants in the blood supply. Bacterial
contaminants in platelets and red blood cells represent the greatest lethal
infectious risks in transfusion medicine today, and no rapid, simple
methods are presently available to effectively address this threat. Each
year an estimated 17 million patients receive more than 60 million units of
these individual blood components in North America, Europe and Asia.
Verax Biomedical, Inc.
veraxbiomedical/