Orasure, a Pennsylvania company, manufactures the over-the-counter HIV in-home test. Once the test is approved, the kit will reach a large market, nearly 250,000 sexually active and at risk men and woman, who won't go into clinics for HIV testing.
The test has been deemed safe and effective--93% accurate for a positive result and 99.8% for negative results. The FDA will decide this year whether or not to approve the kit. 5,384 of the 5,385 negative test results from the OraSure in-home test kits produced one false positive. An FDA reports said the kit also detected 108 of 114 confirmed positive users but test results found eight false negative results.
A panel of 17 experts that approves the drug wants Orasure to post highly visible labels about false negative results. If the kit is approved, HIV testing will become almost as simple as pregnancy testing. As with a positive pregnancy test result, a positive HIV test result warrants immediate healthcare. Pregnant women living below poverty level qualify for Medicaid as do certain HIV/AIDS patients who live below poverty level.
The market is currently testing a pill that prevents HIV altogether. There are also pills on the market (Truvada) that decrease the chances of a males picking up the virus in the event the other partner has already tested HIV positive. Truvada is a tablet used to protect healthy people from the HIV virus. Truvada was approved last week. It was introduced to the public last year.
Even though HIV awareness is prevalent, some say that HIV isn't that easy to get. Nevertheless, a positive test result could be traumatizing and the panel that reviewed Orasure's test kit would like to see the company include a toll free hotline number for those who test positive.
HIV is spread most commonly because sexually active people are unaware or have refused to check if they are carrying the virus. When HIV testing first began, people were "scared" to know their status and wouldn't take the test. People who are still afraid to learn their HIV status, yet remain sexually active and engage in unprotected sex are the biggest threats.
It's estimated that approximately 1.2 million people living in the United States are HIV positive. Another 250,000 are reported to be at risk, but untested. For whatever reasons people fail to get tested, the hope is the in-home kit will catch this market along with other proactive, sexual active men and women.
Orasure's HIV in-home kit is performed from an oral swab from the outer gum area. The oral fluid is not the same as saliva. The test results are available in twenty minutes. And if the kit is approved in the United States, it should retail at $60 per kit.
With a likely approval from the FDA, OraSure Technologies Inc. stocks rose 33 percent to $12.08. After the company's kit is approved by the FDA, Bloomberg reports the company is likely to be purchased by a "major diagnostic" company like Johnson and Johnson, Roche, or Abbot. Bloomberg reports OraSure is valued at $581.4 million.