Regulatory Actions

GenPrime Initiates External Clinical Trials of its Bacterial Contamination Test for Rapid Detection of Bacteria in Platelets

Published in FDA Law Weekly, November 1st, 2007

GenPrime, Inc. a leading provider of rapid microbial analysis technologies, has initiated multi-site clinical trials of its Bacterial Contamination Test for Platelets(TM). The test is a rapid QC device for detecting the presence of aerobic and anaerobic bacteria commonly found in contaminated platelets. The trial will generate data for filing a 510 (K) pre-market notification with the Food and Drug Administration (FDA).

"Undetected bacterial contaminants in platelets tested by culture, dipsticks and other current methods remain a significant source of sepsis and associated patient mortality and morbidity in transfusion medicine," said Buck Somes, chief executive officer...

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Source: FDA Law Weekly (2007-11-01)

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