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Gen-Probe

This article was originally published in The Gray Sheet

Executive Summary

Firm's group A streptococcus direct (GASD) test is slated for official release May 2 after receiving 510(k) clearance March 18. The San Diego-based company hopes the patented "non-isotopic, homogeneous DNA probe" assay, with 91.7% sensitivity and 99.3% specificity, will replace the current gold standard of throat culture, as results are generated in about an hour rather than 24 hours or longer. Gen-Probe's direct sales force will market the GASD test to hospital and reference laboratories for large volume testing
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