FDA Committee Recommends First Ever Rapid In-Home HIV Test

Could Significantly Increase Proportion of Americans Aware of HIV Status, Reduce Transmission

Washington, DC – Today, the U.S. Food and Drug Administration’s Blood Products Advisory Committee recommended approval of the first ever in-home rapid HIV test.  The product – the OraQuick In-Home HIV Test – is manufactured by OraSure Technologies, Inc. and is the same device as the OraQuick Rapid Test, which is already approved for use in a broad range of health care settings and is the standard of care at most testing sites around the country.  Its accuracy, ease, and efficiency have been repeatedly demonstrated in national studies.

“Approximately 50,000 individuals in the U.S. are newly infected with HIV each year,” said National Minority AIDS Council Director of Legislative and Public Affairs Kali Lindsey.  “Even more alarming is the fact that one in five people living with HIV in America do not know it.  The OraQuick In-Home HIV Test would provide an important tool to supplement current HIV screening efforts by providing an accessible, relatively inexpensive device that can be used in the privacy of one’s own home.  This is especially important for minority communities, where HIV stigma often prevents individuals from utilizing traditional testing services.”

Recently, the Institute of Medicine (IOM) examined the extent to which current policies and practices present barriers to HIV testing.  It concluded that minority populations are not only infected at a higher rate than their White counterparts, they shoulder a considerably higher percentage of undiagnosed HIV/AIDS cases.  While the percentage of unrecognized HIV infection among Whites is 18.8, that number is 29.5 among Asians and Pacific Islanders, 25.8 among Americans Indians and Alaskan Natives, 22.2 among Blacks and African-Americans, and 21.6 in Latinos.

“Individuals with unrecognized HIV infection are more likely to unknowingly transmit the virus to others,” continued Lindsey.  “In fact, they are as much as three and a half times more likely to transmit the virus than those who know their status, accounting for more than half of all new HIV infections in the U.S.  Research shows that most individuals take steps to reduce the risk of transmitting the virus following an HIV diagnosis.  Expanded access to testing, including through accurate in-home screening, is an essential tool in slowing the spread of HIV.  At the same time, we must ensure that those who do test positive can easily access care and support services, much like those included in the OraQuick testing package.”

“NMAC believes the OraQuick In-Home HIV Test would provide a critical expansion of current prevention efforts, particularly among minority populations isolated by the persistent stigma surrounding HIV/AIDS,” concluded Lindsey.  “We applaud the committee’s decision today and urge the FDA to approve its use.”


Contact:  Kyle Murphy, (202) 483-6622 ext. 333