Pharmaceutical International News - May 2012
OraQuick Home HIV Testing Kit Approved
Posted by Paul Fiddian - Pharmaceutical International's Lead Reporter on 17/05/2012 - 06:00:00
A US Food and Drug Administration expert panel has approved what could be the pharmaceutical industry's first home-based HIV testing kit available to buy over-the-counter.
Developed by OraSure, the OraQuick In-Home HIV Test has been judged as effective and low-risk and, while it can give erroneous results, it can also potentially halt the spread of HIV, the panel said.
From here on in, the product will go before the US FDA itself. While the FDA isn't compelled to act based on its panel's advice, it generally does follow the same approval or rejection path.
OraQuick In-Home HIV Test
The OraQuick In-Home HIV Test displays a result within 20 minutes and, according to its manufacturer, negative HIV results are 99.8 per cent accurate, while positive results are 93 per cent accurate. Close to 1.2 million US residents presently have HIV and there's 50,000 new diagnoses now being made on an annual basis. This product, therefore, has the potential to make a massive impact on these statistics and not one member of the 17-strong Blood Products Advisory Committee voted against its market introduction.
In comments made to the Associated Press, the AIDS Institute's deputy director, Carl Schmid, supported the Blood Products Advisory Committee's decision. "We are always looking for game changers, and we believe this is one of them", he enthused. "Not only will it help reduce the number of infections but it will bring more people into care and treatment."
Home HIV Testing Kit Approved
However, if this home HIV testing kit is market-approved, the expert panel require OraSure to make clear the prospect of some HIV test results being false. They also want the product's packaging to feature a phone number that's free to call and that offers HIV-based help and advice to those that test positive.
According to OraSure, if FDA-approved, the OraQuick In-Home HIV Test could have an RRP of $60, or less.
Just last week, the Antiviral Drugs Advisory Committee - another FDA expert panel - overwhelming backed the approval of HIV prevention drug Truvada. Again, the FDA now needs to assess the product for itself but this is another potential leap in the fight against HIV.
Pharmaceutical International will revisit both the OraQuick In-Home HIV Test and the Truvada HIV prevention drug in future News coverage.
Image copyright Marcello Casal JR/ABr - Courtesy Wikimedia Commons
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