Alex Philippidis Senior News Editor Genetic Engineering & Biotechnology News

OTC test could decrease transmission by increasing diagnosis and subsequent treatment.

Days before 20,000 researchers descend on Washington, DC, for the XIX International AIDS Conference set for July 22–27, Anthony S. Fauci, M.D., director of the National Institute of Allergy and Infectious Diseases, told the Associated Press: “I think we are at a turning point toward stopping the spread of HIV.”

Such optimism has yet to be reflected in still-sobering HIV statistics. According to CDC, more than 1.1 million Americans lived with the virus in 2009, with up to 218,700 people undiagnosed for HIV.

The Bethlehem, PA, developer of a CLIA-waived HIV test used in doctors’ offices since 2004 reasons it can reduce that last number significantly—and seize a market it says exceeds $500 million—through its new, in-home version of the test, announced earlier this month. The new OraQuick in-home HIV test will start sales in October at the company’s website and 30,000 stores, including Walgreens, CVS, and Rite Aid.

OraSure Technologies says OraQuick can detect antibodies to both HIV-1 and HIV-2 in oral mucosal transudate with an oral swab, with results in about 20 minutes. It’s the first rapid diagnostic test for an infectious disease to be approved by FDA for over-the-counter sale.

“We expect the availability of this test to emphasize the importance of people getting tested, and people who are high-risk of testing more frequently, because there are good therapeutics available. Obviously, you can’t cure or eliminate the virus, but the disease progression can be substantially managed,” Stephen R. Lee, Ph.D., OraSure executive vp and CSO, told GEN.

Jeffrey Conrad Laurence, M.D., editor of AIDS Patient Care and STDs, a journal published by GEN publisher Mary Ann Liebert Inc., told GEN the in-home test should prove valuable in bringing patients to treatment because of its far greater reliability than last-generation tests, which required users to mail saliva or blood samples and await results.

“When we put people on therapy and reduce their viral loads to undetectable, it makes them much less infectious—much less infectious if they get pregnant, much less infectious to their sexual partners. It’s not only for your own health, but for the greater health of potential partners that you are with,” said Dr. Laurence, director of the Laboratory for AIDS Virus Research at Weill Cornell Medical College and New York Presbyterian Hospital. “It’s a very good idea.”

He noted OraQuick’s warning that patients who test positive at home must confirm their findings through doctor-administered ELISA and Western Blot tests.

During its first year, FDA estimates, OraQuick in-home test users will generate 45,000 true positive results, 3,800 false negatives, 2.7 million true negatives, and 1,100 false positives. According to Phase III data presented by OraSure and reviewed by FDA, in-home OraQuick has about 93% sensitivity, or percentage of users with HIV in whom the virus was correctly detected—one false negative result per 12 tests—as well as 99.98% specificity, one false-positive result in every 5,000 tests. Customers can call a live toll-free phone-support center and a website, both capable of providing direct referrals to follow-up counseling and medical care.

FDA approved the in-home OraQuick following a unanimous favorable recommendation in May by the agency’s Blood Product Advisory Committee. Elliot P. Cowan, Ph.D., chief, product review branch for FDA’s Division of Emerging and Transfusion Transmitted Diseases, told the panel the agency projected a net public health benefit to the OraQuick in-home HIV test—a net increase in newly identified HIV infections during the first year, with a net number of HIV transmissions averted as a result.

“This benefit would be expected to increase as more high-risk individuals use the test,” Dr. Cowan said, according to minutes of the advisory panel’s May 15 meeting.

OraQuick shows just how far HIV has evolved in a generation—think Rock Hudson and Freddie Mercury—toward a chronic disease manageable through treatments developed since the 1980s.

“It’s not the death sentence that people attributed to HIV many years ago,” Dr. Laurence said.

Despite the treatments developed since then, the number of Americans contracting HIV annually has stayed steady at about 50,000. Most are gay or bisexual men, followed by heterosexual black women. One-third develop AIDS within a year.

“The big disappointment is that basically there has been no change in the incidence of HIV in the United States for any year since 1992,” Dr. Laurence said. “The best you can say is that it hasn’t gone any higher.”

Authorities hope those numbers will shrink through in-home testing and controversial options such as needle exchanges and treatment-as-prevention, both of which Dr. Laurence said would reduce HIV incidence. In May, FDA’s antiviral drugs advisory committee recommended approval of Gilead’s Truvada as the first pre-exposure prophylaxis (PrEP) drug for HIV; opponents argue it’s less effective than a condom. FDA has postponed a decision until September 14.

Prospects for an HIV vaccine remain remote. Until that changes, people with the virus can only manage the disease—a task that, for some, will begin by discovering they are HIV-positive through in-home tests like OraQuick.

Alex Philippidis is senior news editor at Genetic Engineering & Biotechnology News.

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