OraSure Studying “Site-Specific Factors” Behind Flawed HIV Test Results
This article was originally published in The Gray Sheet
Executive Summary
OraSure is conducting an investigation of its OraQuick Advance rapid oral HIV test due to concerns about the test's reliability, the company said Dec. 20
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Over-the-counter HIV testing in NEJM
Ingrid Katz, MD, and Alexi Wright, MD, Brigham and Women's Hospital, Boston, support the prospect of OraSure gaining over-the-counter approval for its OraQuick Advance rapid oral HIV test. In a perspective piece in the Feb. 2 issue of the New England Journal of Medicine, the authors acknowledge concerns, including test affordability and the recent reports of increased numbers of false positive results at certain clinics, but they say a low number of false positives is less dangerous than people incorrectly assuming they do not have HIV. After attending an FDA advisory panel meeting in November that discussed whether HIV tests should be available for over-the-counter use, both authors feel confident that the product will be approved once these issues are ironed out, they said in an interview (1"The Gray Sheet" Jan. 2, 2006, p. 23)....
Over-the-counter HIV testing in NEJM
Ingrid Katz, MD, and Alexi Wright, MD, Brigham and Women's Hospital, Boston, support the prospect of OraSure gaining over-the-counter approval for its OraQuick Advance rapid oral HIV test. In a perspective piece in the Feb. 2 issue of the New England Journal of Medicine, the authors acknowledge concerns, including test affordability and the recent reports of increased numbers of false positive results at certain clinics, but they say a low number of false positives is less dangerous than people incorrectly assuming they do not have HIV. After attending an FDA advisory panel meeting in November that discussed whether HIV tests should be available for over-the-counter use, both authors feel confident that the product will be approved once these issues are ironed out, they said in an interview (1"The Gray Sheet" Jan. 2, 2006, p. 23)....
OraSure woes
A Los Angeles clinic says it will stop using the OraQuick Advance rapid oral HIV test due to a number of false positive test results, which caused the firm's stock price to drop over 20% Dec. 16 from a Dec. 15 close of $11.37. Similar false positive results from clinics in New York and San Francisco have also been reported. The firm is working with health departments where the false results were reported, but stressed that the test is intended as an initial screening device and that labeling instructs those with positive results to seek further testing. OraSure received another blow Dec. 14 when the House approved a measure stripping language from the HHS appropriations bill that would have directed HHS to buy one million rapid oral HIV tests...