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OraSure woes

This article was originally published in The Tan Sheet

Executive Summary

Reports of increased false-positive test results from OraSure Technologies' OraQuick Advance rapid oral HIV tests are not expected to affect prospects for OTC status, the Bethlehem, Penn.-based firm maintains Dec. 15. OraSure stock fell more than 20% Dec. 16 from a Dec. 15 close of $11.37 after a Los Angeles clinic announced it would stop use of the test. The announcement followed reports of false-positives from clinics in New York and San Francisco. The stock had hit a 52-week high of $14.14 in early December after a November advisory committee meeting to consider OTC sale (1"The Tan Sheet" Nov. 7, 2005, p. 7). The firm is "taking the reports seriously" and is working with health departments in cities where false results were reported. OraSure stressed the test's role as a screening device, noting the label instructs those with positive results to proceed to further testing. The test's accuracy rate remains above 99%, the firm adds. OraSure previously proposed actual-use testing to determine if labeling is adequate to drive users with positive results to confirmatory tests...

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