News | October 17, 2007

GenPrime Initiates Clinical Trials of Contamination Test for Rapid Detection in Platelets

October 18, 2007 - Rapid microbial analysis technology company GenPrime Inc. initiated multi-site clinical trials of its Bacterial Contamination Test for Platelets yesterday.
The company says 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) premarket notification with the FDA.
Currently, more than 10 million platelet units are transfused annually into patients worldwide. It is estimated by transfusion medicine experts that as many as one in 2,000 of these units are contaminated with bacteria. While culture based tests, which can take two to three days before results are available, have reduced the chances of contaminated platelets being infused, septic reactions continue to be reported. Traditional rapid tests such as dipsticks, staining and microscopy are highly unreliable, GenPrime officials said. They said there remains an unmet need in the transfusion industry for a sensitive, rapid, and reliable test that is user friendly and can provide accurate, objective results.
Based on a novel, easy to use, proprietary lateral flow technology platform, GenPrime’s Bacterial Contamination Test for Platelets is designed to detect all 15 organisms known to contaminate platelets. Additionally GenPrime has developed an automated test reader and software for objective result analysis and data collection. The company has completed optimization, scale-up and pre-clinical studies of the test and expects to complete the clinical trial and file the 510(K) premarket submission to the FDA in early 2008.

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