Diagnostics & Imaging Week Associate

Oral fluid diagnostics company OraSure Technologies (Bethlehem, Pennsylvania) said it will make its case in November to be the first company to offer an over-the-counter (OTC) home-use rapid HIV test.

If the OTC test for the detection of the HIV virus which causes AIDS is cleared, it would be the culmination of an 18-year saga that saw the first at-home AIDS test application in 1987 turned down because of concerns by AIDS advocates and government regulators over follow-up counseling and professional support for those who test positive for the disease and the possibility of a glut of suicides spawned by such a diagnosis.

The company will present its case for an approval at a meeting of the FDA’s Blood Products Advisory Committee (BPAC) on Nov. 3.

Douglas Michels, the company’s president and CEO, told Diagnostics & Imaging Week that his company is uncertain what the exact format of the meeting will be.

“We haven’t been told precisely what the format is going to be,” said Michels. “We’ve been asked to come and present information about our test and its performance and the studies that have been done on our products both in support of existing FDA approval and other studies that have been conducted.”

OraSure Technologies is the manufacturer of the OraQuick Advance Rapid HIV-1/2 Antibody Test – the same test proposed for over-the-counter use. The test, which was cleared by the FDA in March of last year is the first and only FDA-approved, Clinical Laboratory Improvements Amendments of 1988 (CLIA)-waived, rapid point-of-care test that provides results for both HIV-1 and HIV-2 with greater than 99% accuracy in as little as 20 minutes, using an oral fluid, finger-stick or venipuncture whole blood or plasma sample.

The OraQuick requires a person to simply swab their gums and then place the swab in a holder. Twenty minutes later, a strip displays one line for a negative result and two lines for a positive one.

The original version of this rapid test, the OraQuick Rapid HIV-1/2 Antibody Test, was FDA-cleared in November of 2002 for detection of antibody to HIV-1 in blood, essentially a fingerstick test. And on March 19, 2004, the test was FDA-cleared for the detection of HIV-2 – a variant of HIV.

William Bruckner, vice president of strategic marketing for OraSure, told D&IW in an interview after the March 2004 FDA clearance that to make the product available over the counter would depend primarily on joint decision-making by the Centers for Disease Control and Prevention (Atlanta) and the FDA. “They’re looking to see how they would involve counseling with that kind of protocol,” he said.

“Counseling is a very important aspect of HIV testing,” said Michels, who characterized that issue as one more of access or linkage to care. Whether that be counseling or follow-on testing.”

What is important, he said, is that these OTC testers, “whether they are performing a test or when they have a negative result or a positive result, that they have some ability to access individuals [who] can help them understand next steps.”

Michels said the company plans to include advice about counseling on OraQuick’s label. “It could be a hotline number, a 24-hour manned counseling center, web support or printed material that is included in the product,” he said.

According to an article on the test in the Oct. 13 edition of The New York Times, nearly 40,000 people each year in the U.S. continue to be infected by HIV. For this reason, many once reluctant AIDS advocates are now supporting the testing with the hope that it could finally lead thousands to change their sexual behavior and stop infecting other people.

These same advocates are now less worried about the increased risk of suicide since HIV and AIDS can now be regulated as a chronic disease and are no longer the death sentence they once were, at least in the countries where people can afford the expensive medication to manage the condition.

Having tried many other strategies, federal health officials are now also increasingly open to the idea of an at-home AIDS test.

“If we’re going to win the war against AIDS, we need to make HIV testing as easy as pregnancy testing,” Freya Spielberg, MD, a researcher in the Center for AIDS Research at the University of Washington (Seattle) told The Times.

Spielberg said that about a quarter of the nearly 1 million people in the U.S. who have the HIV virus in their blood do not know that they are infected. And somewhere between 40% and 45% of those who test positive for HIV do so less than a year before they are diagnosed with AIDS.

Since an HIV infection often takes a decade to develop into full-blown AIDS, “this suggests that people are living with HIV, and spreading HIV for many years before they are aware of their infection,” she said.

Spielberg said that she surveyed 240 people infected with HIV and found that more than half said that they would have preferred to have found out about their infection with a rapid at-home test.

The company said it would include whatever the advisory committee and the FDA deems is necessary. The company now sells the device for between $12 and $17. However, Michels noted that the price of an OTC version has not yet been decided upon.