FDA Gives Preliminary Approval to OraSure’s Rapid HIV Test
The FDA has given preliminary approval to OraQuick, a rapid HIV test created by Bethlehem, Pa.-based OraSure Technologies, the company announced on Monday, the Allentown Morning Call reports (Berg, Allentown Morning Call, 5/14). The test requires only "a drop" of blood and can produce results in 20 minutes, while standard HIV blood tests require "blood drawn from a vein" and take approximately 10 to 14 days to register results. "Anything we can do to get results more quickly for people who want to know their HIV status will be a great step forward," Dr. Tim Friel, assistant medical director for AIDS activities at Lehigh Valley Hospital in Allentown, said (Wlazelek, Allentown Morning Call, 5/14.) Public health officials say that the number of new HIV cases will decrease as more people find out their status and take steps to prevent transmission to others. A "major" problem is that one-third of people who are tested for HIV in public clinics never return to find out their results (Wall Street Journal, 5/16). In addition, a rapid HIV blood test could be "especially valuable" to health care workers or newborns who are exposed to HIV, Dr. Jeffrey Jahre, chief of medicine at St. Luke's Hospital in Bethlehem and an infectious disease specialist, said, adding that health care workers and infants would not have to take antiretroviral drugs to prevent HIV transmission if the source patient or woman tests negative for HIV antibodies. However, OraQuick, like other tests for antibodies, "would not solve the problem of a two- to four-week 'window'" during which a person may be infected with HIV but is not yet producing antibodies against the virus (Wlazelek, Allentown Morning Call, 5/14).
In order to receive full FDA approval of the test, OraSure must meet FDA-specified conditions regarding the test's labeling and manufacturing (Berg, Allentown Morning Call, 5/14). However, OraSure and public health officials say that "two major obstacles remain." First, the test does not detect the less-prevalent strain of HIV-2, because the company has not been able to receive a license on the virus. Only about 200 cases of HIV-2 have been reported in the United States, compared to about 700,000 cases of HIV-1, the most common type of the virus. Second, OraSure only included a request for the test to be approved for use in a laboratory setting, after the company received "resistance" from laboratory workers at an FDA advisory meeting last year. However, public health officials believe that the test would be most useful if it were used in doctors' offices and public health clinics. "We decided to wait until we get FDA approval and then focus on doing the work to get the broader approval," Sam Niedbala, chief scientific officer at OraSure, said. The company expects to receive final approval later this year (Wall Street Journal, 5/16).