WORCESTER, Mass., Sept. 28 /PRNewswire/ -- Verax Biomedical, Inc., a leading developer of rapid tests for detecting bacterial contaminants found in blood cells and tissue, has initiated an external clinical trial of its Platelet PGD(R) Test at University Hospitals Case Medical Center and at the Cleveland Clinic. The trial will generate data for filing a 510(k) pre-market notification with the Food & Drug Administration (FDA) for the QC testing of platelets for the presence of bacteria.
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"Bacterial contaminants in platelets and red blood cells represent the single greatest source of fatalities in transfusion medicine today," said Jim Lousararian, chief executive officer of Verax Biomedical. "We believe our technology may provide a quick and practical solution to this problem."
The company's Platelet PGD test is designed to detect the presence of a broad range of bacterial contaminants in platelets just prior to transfusion. Currently, over 10 million platelet units are transfused into patients in North America, Europe and Asia each year. Transfusion medicine experts estimate that as many as 1 in 2,000 of these units are contaminated with bacteria. In recognition of this risk, the American Association of Blood Banks has implemented a standard to require methods to limit and detect bacterial contamination in platelets.
The Platelet PGD Test is designed to be an easy-to-use disposable device that provides results in less than 30 minutes. Currently, QC testing platelets for the presence of bacterial contaminants using culture methods can take two to three days before results are available.
"Current testing methods miss at least half of all bacterial contaminations, and sepsis and fatalities continue to be reported after platelet transfusions. We need a better way to detect bacteria in platelet units, and PGD may provide a simple way of doing this," said James P. AuBuchon, MD, professor of pathology at the Dartmouth-Hitchcock Medical Center in Lebanon, New Hampshire.
Verax PGD tests are based upon the company's proprietary Pan Genera(R) Detection technology. The first target application of this technology is a quality control test to determine the presence of bacterial contamination in human platelets. The privately-held company has already completed optimization, scale-up, and internal and external pre-clinical studies of its Platelet PGD Test. A 510(k) is a pre-marketing submission made to the FDA to demonstrate that the device intended to be marketed is as safe and effective and thus, substantially equivalent to, another legally marketed device that is not subject to pre-market approval.
For additional information, contact Verax Biomedical, Inc., Four Biotech, 377 Plantation Street, Worcester, MA 01608. Tel.: 508/755-7029, or visit http://www.veraxbiomedical.com.
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.
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