For the first time in history, the FDA will decide whether or not to make available an over-the-counter, in-home HIV test by OraQuick. This would allow individuals to test themselves at home in lieu of medical supervision.
The Food and Drug Adminstration’s briefing documents, which are accessible online, stated that the OraQuick HIV In-home test would be instrumental in slowing the spread of this often deadly disease. The test is administered via a mouth swab and results are usually ready in about twenty minutes. The FDA does however, have concerns as to the reliability and accuracy of the test.
This information was released just one day after the preventative HIV pill called Truvada was endorsed by an FDA advisory panel. Truvada would set a huge precedence in becoming the first ever approved drug with a purpose to protect healthy individuals from potentially deadly aids viruses.
With nearly a fifth of the U.S. population unaware that they even carry the virus, testing is one of the most effective methods to minimize new infections. Public health officials also state that new infections have remained at about 50,000 a year over the past twenty years.
A recent trial fell just below the FDA threshold of 95% accuracy. The trial was carried out by OraSure Technologies Inc. Their trial test had a detection rate of 93%, just 2% below FDA thresholds.
If the OraQuick kit is made available to U.S. population, the preceding FDA figures reveal that approximately 3,800 HIV-positive individuals would go undetected.
In direct contrast, it had a 99% accuracy in identifying those who are HIV-negative. This trial was conducted by the drug company itself.
FDA scientist also explained, in their briefing report, that personal in-home diagnostic kits carry both potential benefits and complications.
The reviewers went on to say that although measurable value is to be gained in individual and public health, that this is outweighed by the fact the some people will receive a misdiagnosis and continue to be unaware they are in fact infected.
In an effort to make the best possible decision, the FDA decided to consult a panel of outside authorities on the topic for their opinion. If the outside panel approves the in-home kit, the FDA still reserves the right to go against their findings, although they often concur.
OraSure is located in Bethlehem, PA. Since 2004 they have been supplying a similar kit to doctors, nurses and various other health care professionals. The price of the product that would be released to the general public has not yet been given by OraSure, although the professional version sells for around $17.50. The version used by health practitioners has shown an accuracy reading of 99% for those infected as well as those who are not infected.
CEO, Doug Michels, stated there was no surprise of that the OraQuick kit is less accurate for consumers than professionals. He maintained that company officials expected that it would generate higher accuracy numbers when handled by professionals.
In the latest variant of the drug, an OraSure trial of 5,800 consumers of different ages, income levels and sexual orientation revealed 100 HIV carriers who had never before been diagnosed as infected with the virus.
There are currently approved FDA home test kits on the market. However, these kits require a blood samples and must be sent to a laboratory for results. OraSure maintains that a test where the result can be known without shipping it an outside location will be highly received by a larger portion of the population.
OraSure’s study also revealed, that 41% of individuals who tested positive for HIV, had no past testing before using their kit. OraSure went on to state that for every one million individuals that use their test, 9,000 new HIV-positive identifications will be made. All this was according to their own briefing documents.