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NAPWA salutes FDA Advisory Committee for recommending approval of OTC home HIV test

NAPWA salutes FDA Advisory Committee for recommending approval of OTC home HIV test, urges public education about implications of both positive and negative test results

(Washington, D.C., May 16, 2012) - The National Association of People With AIDS (NAPWA) Drugs Advisory Committee for recommending approval of OraSure's OraQuick In-home HIV Test kit. We urge the FDA to follow the Advisory Committee's recommendation and approve the kit for over-the-counter sale.

With an estimated one-fifth of Americans who live with HIV unaware they are infected, there is an obvious need for more testing and more ways to get tested. There are people who need to get tested who will not do so in a traditional medical setting. We hope many of them take advantage of a home test kit to learn their status, so they can seek treatment for their infections, stay healthy, and take steps not to infect their partners.

We recognize that some who receive a positive result from the home test kit will be traumatized and need immediate emotional support and suicide prevention assistance. Others will need help understanding the HIV health care system and the care options they have. We urge OraSure and the FDA to provide 24-hour toll-free hotlines for people who need help coping with their test results or finding treatment and support resources.

We also call for a major public information campaign when in-home test kits become available in pharmacies without prescription, emphasizing that HIV is treatable but left untreated can kill, that people receiving effective treatment are less likely to transmit HIV to others, and that they may be eligible for ADAP and other Ryan White programs if they do not have meaningful private health insurance. The campaign should also explain that there is a small risk of false positive and false negative results, that it may take three to six months for a new infection to be detectable, and testing negative does not mean one can stop practicing safe sex.

"We welcome in-home testing," said Stephen Bailous, Executive vice President of NAPWA and Chairman of the Washington, D.C. EMA Ryan White Planning Council. "We know there are risks in allowing people to test themselves for HIV without counseling, but we also know we are still seeing more than 50,000 new HIV infections every year, and a large majority of them come from sexual contact with people who do not know they have the virus. Reducing the number of undetected, untreated HIV infections will bring the number of new infections down. In-home testing is one of many new testing and treatment options that promise to bring the end of AIDS in America."


The National Association of People with HIV/AIDS (NAPWA)Founded in 1983, NAPWA is the largest and oldest advocacy organization for PLWHA, and the most trusted voice in the HIV/AIDS community advocating for the lives and dignity of all people living with and affected by HIV/AIDS, especially the more than 1.2 million Americans living with it today. To learn more, visit


CONTACT:Paul DeMiglio (240) 247-1018

"Reproduced with permission - "National Association of People with HIV/AIDS (NAPWA) "

National Association of People with HIV/AIDS (NAPWA)

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