FDA Set To Approve Quick Finger-Prick HIV Blood Test in Next Two Weeks
Analysts expect that the FDA within the next two weeks will issue final approval for a fast-response finger-prick HIV blood test, the Los Angeles Times reports. According to sources close to the approval process, the FDA has resolved "lingering technical and manufacturing issues that have held up approval" (Ornstein, Los Angeles Times, 9/28). In May, the FDA awarded preliminary approval to the HIV test, which requires only one drop of blood and can produce results in 20 minutes. Standard HIV blood tests require blood taken from a vein and take about 10 to 14 days to produce results (Kaiser Daily HIV/AIDS Report, 5/16). Some AIDS advocates and public health experts have asked the FDA to waive a requirement that patients can undergo the test only in "technically sophisticated" laboratories. Advocates hope to use the test to target the more than 9,600 HIV-positive individuals each year who undergo HIV tests at public health clinics and do not return to obtain their results. Dr. Nelson Michael, chief of molecular diagnostics and pathogenesis at Walter Reed Medical Army Institute of Research, said, "These tests are ridiculously simple. You basically defeat that ease of testing if you demand that the test be executed in sophisticated laboratories." However, College of American Pathologists spokesperson Dr. Jared Schwartz said, "Until it can be determined that individuals performing this test out on the street have a significantly high degree of accuracy in performing the test, the potential danger to the person being tested is simply too high at this point." Although some advocates have "accused the FDA of dragging its feet" in the approval of the test, Dr. Elliot Cowan, a senior regulatory scientist at FDA, said that the agency has worked "on it as fast as we can. ... It would be far worse in my mind, at least, to approve a product and then have it fail once it reaches the marketplace." Ron Spair, CFO of OraSure Technologies, which manufactures the test, called OraQuick, said that FDA officials have a "regulatory protocol that needs to be followed, and they are following that. I can't characterize anyone as stonewalling this" (Los Angeles Times, 9/28).This is part of the KHN Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.