FDA decision countdown for OraSure Print E-mail
By Brian Wilson, Contributor   
Monday, 30 April 2012 05:36
OraSure Technologies (OSUR) is an established medical device company on the verge of a very important FDA decision regarding its potentially groundbreaking product OraQuick ADVANCE Rapid HIV-1/2 Antibody Test. OraQuick has a number of advantages, the most impressive of which is the device’s ability to produce results in 20 minutes while being extremely simple to use. The product doesn’t require any blood samples either (it uses oral fluid), which only makes it more attractive.

If Orasure is given the nod by the FDA, OraQuick would be the first OTC diagnostic tool for HIV, which would capture an enormous demographic. According to the CDC, an estimated 16-22 million people are tested for HIV every year in the United States alone. Given the fact that many are hesitant to get testing, these numbers could be much higher if OraQuick receives approval.

More statistics by the CDC imply that HIV testing is the most effective current solution to the crisis – more than 232,700 out of the 1.1 million Americans infected with HIV don’t know they are infected. Anywhere between 54-70% of new infections are caused by those unaware of their infection by the HIV virus. This statistic in particular helps the case for OraQuick’s FDA approval immensely, given that the test can meet the proper thresholds in accuracy testing.

While there is no currently set date for the FDA decision regarding the drug’s approval OraQuick is scheduled to be discussed at the FDA’s Blood Products Advisory Committee (BPAC) on May 15. We assume that the results of this conference will be a very accurate indicator as to whether or not the medical device will be approved, and hence a major drive of the stock.

In addition to OraQuick for HIV testing, OraSure is already selling a similar product (also named OraQuick) for HCV (Hepatitis C Virus) testing. This product was approved in April 2011 for fingerstick whole blood samples, and has been largely responsible for the stock’s ~50% appreciation in the last year. While past performance doesn’t guarantee future results, it’s reasonable to assume that OraQuick ADVANCE for HIV will induce a similar effect on OraSure’s stock after it’s likely approval.

OraSure Technologies leverages proprietary and cutting-edge scientific expertise to develop accurate and easy-to-use products that help make sensitive healthcare situations, such as HIV testing, substance abuse testing and wart removal. Its core platform technologies include: OraQuickr and OraSurer. The company's OraSurer Oral Specimen Collection Device is a generic device which was developed and FDA approved for the purpose of collecting, preserving and transporting oral fluid specimens. It completely eliminates the risk associated with handling needles and blood. The company's OraQuickr rapid test platform for oral fluid, fingerstick, whole blood and plasma, has been approved by the FDA for testing for HIV-1 and HIV-2 antibodies. It also develops and markets a proprietary cryogenic technology for the treatment of warts and other benign skin lesions. This technology is sold as the Histofreezerr Portable Cryosurgical System.

OraSure Technologies has agreements with Roche Diagnostics Corp, Roche Holding Ltd, Schering-Plough Corporation, Inverness Medical Innovations Inc, Schering-Plough Corporation, Abbott Laboratories, Novation LLC, Chiron Ortho-Clinical Diagnostics, Novartis AG, Johnson & Johnson, Novartis Vaccines and Diagnostics Inc, etc.

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