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At-home AIDS test weighed
Feds to consider letting OraSure sell its current HIV-test over-the-counter.
October 13, 2005: 5:43 PM EDT
By Shaheen Pasha, CNN/Money staff writer

NEW YORK (CNN/Money) - After almost 20 years of controversy, consumers may finally be able to test for the AIDS virus at home. But is the market ready?

OraSure Technologies thinks so. And its chief executive Doug Michels said the company has been in discussions with the Food and Drug Administration for about 6 months to bring its OraQuick test – which uses oral fluid from the gums to determine the presence of the HIV virus – directly to consumers.

At-home AIDS tests are hardly a new concept. These tests have been at the center of debate in the past as AIDS advocates and the FDA feared that allowing a user to test for HIV at home could result in panic and result in possible suicides if the diagnosis was positive. Advocates also feared that home test users may not have adequate access to HIV counseling and information that would be readily available at a clinic or doctor's office. Those concerns quashed a 1987 application for an at-home AIDS test.

There are an estimated 40,000 new HIV infections every year. And more disturbing, half of those new infections are the result of people being unaware they are infected, Michels said the company hopes to provide an easier way for people to test themselves.

Currently, the OraQuick Advance test is available in doctor's offices, clinics, and substance abuse health facilities. OraSure's financial chief Ron Spair said the company sold 1.5 million tests in 2004 and is on track to sell 2.5 million to 3 million tests this year. Users can get results in just 20 minutes and with over 99 percent accuracy rate, the product has met with success.

And AIDS advocates are starting to warm up slowly to the prospect of home-testing.

"I think that home testing does have a role to play in an overall HIV testing program," said Gene Copello, executive director of The AIDS Institute, a Washington D.C.-based national public policy organization. "But there needs to be a lot of talk and consideration of what that role needs to look like."

Copello said any home-testing system would also have to make sure that there are resources available to a test user such as a 24-hour hotline to answer questions or provide referrals.

As opposed to 20 years ago, he added that the current environment is better suited for over-the-counter HIV tests because there are treatments available that can allow an HIV-positive person to live a relatively normal life – taking away the prior stigma of HIV being a death sentence.

The FDA's Blood Products Advisory Committee will hear OraSure's proposal to sell its rapid HIV test, OraQuick Advance Rapid HIV-1/2 Antibody Test, on Nov. 3.

While there is no guarantee that the committee will recommend approval of OraSure's rapid testing product, OraSure's Michels said "the FDA has been very cooperative and collaborative" in past discussions. He wouldn't comment further on the company's expectations for the meeting but a report in The New York Times indicated that the company plans to apply formally to sell the device over-the-counter after the federal advisory board meeting in November.

And Wall Street sees the committee's willingness to hear the proposal as a huge first step for the company.

William Quirk, research analyst at RBC Capital Markets, said the OraQuick Advance test is one of the company's most important growth drivers. The test accounted for about $6.2 million in revenue in the second quarter – about 35 percent of the company's overall revenue. And while OraSure has called for 20 percent total revenue growth in 2006, Quirk said he estimates it could jump as much as 35 percent. (See correction.)

"I would imagine that the profitability (of an at-home test) would be on par with the current product," he said, adding that it's still too early to determine whether OraSure will get a positive recommendation from the federal committee.

OraSure's Michels also said that it was too early to comment on how much profit the company could experience if the product hits the shelves, saying that estimates would be tied to pricing and market opportunity.

The test is currently sold to medical professionals for between $12 and $17, but a price for an over-the-counter version hasn't been determined, he said.

Correction: OraSure's 20 percent revenue growth estimate is for total revenue. In an earlier version of this story, it was incorrectly described as growth for its OraQuick test.(Return to story.)  Top of page

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