Important note: Information in this article was accurate in 2008. The state of the art may have changed since the publication date.

Reuters NewMedia - November 28, 2008
Jennifer Robin Raj

The over-the-counter (OTC) version of OraSure's rapid HIV test, on which the company is yet to complete a final study, would have an estimated market of more than $500 million, Chief Executive Douglas Michels told Reuters.

According to UNAIDS, the arm of the United Nations that works on HIV prevention and care, people fail to be tested for HIV for many reasons, including lack of access to testing services, fear of stigma and discrimination.

An HIV test that could be bought in a supermarket, administered in one's home and delivers results within a short timeframe may encourage more to get tested.

When asked if the OTC product is likely to be launched only in 2010, Michels said, "I will not make that conclusion. It is all going to depend on FDA's (Food and Drug Administration) timing. What I know for sure is that we have a meeting with FDA in mid-December."

The company is scheduled to discuss the results from the completed studies and the final study protocol related to the OTC rapid HIV test with the FDA in mid-December.

OraSure expects to execute the final study, where participants will test and interpret results at home without the observation of a trained healthcare worker, in the first half of 2009, Michels said.

OraSure's OTC test would duplicate the functionality of its OraQuick Advance test, which detects antibodies to both HIV-1 and HIV-2 -- the two strains of the virus that cause AIDS, and deliver results within 20 minutes, but in a home setting.

The OTC test, however, uses only oral fluid samples from the tissues of the cheek and gum, while OraQuick Advance can also use blood and plasma samples.

"OraQuick can't be bought in a supermarket or a pharmacy," company spokesman Ron Ticho said. "So if and when approved, the OTC test would be the first test a consumer can purchase in the market to get a rapid HIV test result."

The U.S. list price for OraQuick Advance is about $17 per test, Ticho said, but added it was too early to comment on pricing for the OTC version.

PRICING PRESSURE

Pharmaceutical companies face pressure from governments, AIDS activists and other groups to sell treatment at cheaper prices in developing parts of the world.

"Indeed, there are those pressures," Michels acknowledged, adding that the company has differential pricing on OraQuick Advance in the developing parts of the world.

The company manufactures not just in the United States but also in Thailand, Michels said, and that allows it to sell the product at lower prices in developing countries.

"There are lot of rapid HIV tests (by other companies) that come out of China and India that are not necessarily manufactured under good manufacturing practice conditions," he said.

"They are sold in many cases substantially lower than what we can offer our technology for (but) the end-user is going to make a decision based on reliability, accuracy and value.

"We can still sell the product in those areas and make a reasonable, but certainly lower, profit margin," he said.

The company is also looking to garner revenue from its rapid Hepatitis C Virus (HCV) test, which OraSure estimates has a market of more than $250 million.

However, the CEO declined to comment on whether the company expects revenue from the HCV test in 2009, saying it would depend on the regulatory process.

OraSure, based in Bethlehem, Pennsylvania, applied for approval for the HCV test with the FDA in October and plans to apply for European approval over the next several months.

(Editing by Himani Sarkar)

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