Testing, Testing, H-I-V

You may have missed it, but June 27 was National HIV Testing Day--an opportunity to raise public awareness not only of the persistent risk of that viral scourge but also of the latest innovation in rapid-testing devices.OraQuick Advance, which can detect both HIV-1 and HIV-2 antibodies within 20 minutes, is the only rapid HIV test on the market that can use oral fluid--via a mouth swab--to provide a result. Other quickie tests require a blood sample.

"We recognized the need for rapid HIV test in the marketplace," said Ronald Spair, chief financial officer for Bethlehem, PA-based OraSure Technologies, the maker of OraQuick Advance. "And in terms of marketing, we considered not only the convenience of the OraQuick Advance but also its noninvasive nature."

Spair pointed to Centers for Disease Control and Prevention (CDC) estimates that one-third of the 2.2 million Americans tested for HIV at public health clinics each year using the traditional lab-based test do not follow up two weeks later to learn the results. "We think the reason may be multifactorial, including the time lapse between testing and getting the result and [the patient's] lack of basic understanding of the result itself," Spair said. The company is also developing a test for hepatitis C, a leading coinfection among people with HIV.

In order to heighten visibility for OraQuick Advance--and to underscore the importance of knowing your HIV status--the company joined with the National Association of People with AIDS to host Testing Day's main event, the third-annual Mayors' Campaign Against HIV. The campaign counters the stigma and fear of HIV testing by showcasing mayors in major US cities opening wide for the rapid oral-fluid method. To date, more than 30 mayors' offices have participated.

Because HIV infection is growing disproportionately among people of color and the poor, the CDC launched an initiative in 2004 to establish HIV testing as a routine part of most medical exams--for example, at hospital ER visits. The initiative has proved controversial among advocates and some doctors because it does not require written consent, raising the specter of mandatory testing. The CDC is spending some $2.3 million this year on OraQuick Advance tests.

The device maker is aiming for FDA approval to sell its test, which was initially approved for use in 2004, to consumers in the United States in early 2009. OraQuick Advance got the green light for marketing in the European Union earlier this month. The current price for clinics, community-based organizations, and other prevention groups is $17 a kit. But since these groups often administer the test for free, it remains to be seen how big the consumer market will be.