Over-the-counter HIV testing in NEJM
This article was originally published in The Gray Sheet
Executive Summary
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)....
You may also be interested in...
OraSure Studying “Site-Specific Factors” Behind Flawed HIV Test Results
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
US Q1 Consumer Health Earnings Preview: Label This One Historic And Challenging But Promising
US OTC drug and supplement firms’ reports of results for the first three months of 2024 began on April 19 with P&G. JP Morgan analysts say while “some retailers in the US in particular” are reducing consumer health inventories, for the overall sector they expect “a healthier balance of positive volume and lower pricing contribution.”
Keeping Track: Cancer Approvals From Lumisight Imaging To Adjuvant Alecensa
The US FDA’s approval of Lumicell’s optical imaging agent Lumisight makes a dozen novel approvals in 2024 for the Center for Drug Evaluation and Research.