SPOKANE, Wash., Oct. 17 /PRNewswire/ -- 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 of GenPrime. "We believe our technology will offer a practical and rapid solution to further mitigate this problem."
Currently, over 10 million platelet units are transfused annually into patients worldwide. It is estimated by transfusion medicine experts that as many as 1 in 2000 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. 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(TM) 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 5
|SOURCE GenPrime, Inc.|
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