Verax PGD Test Receives New FDA Clearance for Individual WBD Platelet Units.
M2 PHARMA-April 11, 2017-Verax PGD Test Receives New FDA Clearance for Individual WBD Platelet Units
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- The US FDA granted a new clearance for US-based diagnostic test developer Verax Biomedical Platelet PGD Test when applied to single units of leukoreduced or non-leukoreduced whole blood derived platelets in plasma, expanding its range of FDA-cleared indications for use, the company said.
This test is already FDA cleared for testing post storage pools of up to six (6) leukoreduced or non-leukoreduced WBD platelets in plasma.
Individual units of WBD platelets are often used as pediatric doses in US hospitals. This new clearance helps reduce the risk of bacterial contamination for a patient population of particular concern to all health care professionals.
The Verax PGD test is already FDA cleared as a Safety Measure for bacterial contamination in platelets, meaning it can also be used to extend platelet dating to 7 days when testing apheresis platelets in plasma.
Verax said its patented Pan Genera Detection technology is ideally suited to address the need for rapid and practical tests for bacterial contamination, due to its unique and proven ability to detect a wide variety of possible bacterial contaminants quickly, cost effectively and with minimal labor.
The PGD test only has to be run once on a platelet dose before it is transfused to reduce the risk of sepsis caused by bacterial contamination.
Verax Biomedical is the producer of the Platelet PGD Test, the only test for bacterial contamination in platelets granted a Safety Measure claim by the FDA.
The test can be used to extend the dating of apheresis platelets in plasma, the most common platelet type transfused in the US, from five to seven days.
This dating extension offers the opportunity for significant cost savings to the hospital and blood banking community while preserving a critical life giving resource.
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|Date:||Apr 11, 2017|
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