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News

Verax Platelet PGD Test for bacterial detection receives CE Mark

Verax Biomedical : 28 September, 2008  (New Product)
Verax Biomedical's Platelet PGD Test for bacterial detection has now received the CE Mark.
The test, which received 510 (k) clearance from the US FDA in September 2007, holds potential to improve the safety of the blood supply by easily and quickly detecting a broad range of bacterial contaminants.

'With an estimated risk that as many as 1 in every 2,000 platelets are contaminated with bacteria, there is a clear unmet need in Europe for a simple, rapid, low-risk technique to detect and discard those contaminated units,' said Joe Sanders, vice president of marketing for Verax. 'The Platelet PGD Test meets that need with broad spectrum testing and rapid results. These characteristics, combined with the test's ease of use, allow it to be easily incorporated into routine testing.'

The Platelet PGD Test has now demonstrated the ability to reliably detect a broad variety of common bacterial contaminants in buffy coat platelets. A key benefit of this test is that it enables rapid bacterial detection without the need for costly and complex pathogen reduction methods that may introduce other risks into the platelet unit. The ability of the test to detect bacteria in apheresis platelets has previously been demonstrated in extensive US validation studies.

'CE Marking of the Platelet PGD Test is an important step in improving blood safety on a global level,' said Jim Lousararian, chief executive officer of Verax Biomedical. 'We believe this test, and the technology it is founded on, are critical tools in the battle against bacterial contamination.'

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 at a later phase in platelet unit life than current culture methods. 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 1 in every 2,000 units are contaminated with bacteria.

The Verax Platelet PGD Test is based on Verax Biomedical's proprietary PGD Bacterial Detection Technology, which targets common antigens found on the surface of all species of bacteria known to be pathogenic to humans.
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