Washington Editor

GAITHERSBURG, Md. - An FDA advisory panel came down in favor of eventual over-the-counter (OTC) sales of HIV tests, an opinion that buoyed manufacturer OraSure Technologies Inc., which is likely to move forward with its plans.

"It's our definite intent," Doug Michels, the company's president and CEO, told BioWorld Today. "I think after our next meeting with the FDA, in which we discuss that, we'll have a better idea on the timing."

He said Bethlehem, Pa.-based OraSure hopes to secure that meeting within the next 30 days to begin to lay down an OTC regulatory path for its OraQuick Advance rapid HIV-1/2 antibody test, which already has FDA clearance for use in hospitals and labs. The oral fluid product's "rapid" designation stems from its ability to deliver an answer in 20 minutes, during which time it detects antibodies to HIV-1 and 2 from a a saliva swab.

Gaining OTC status is likely to require clinical studies to ensure that the oral fluid product's packaging and labeling translate into correct usage. That was the general message sent by members of the FDA's Blood Products Advisory Committee.

"It's feasible for such a test to be developed, with due caution," said Jay Epstein, the director of the agency's Office of Blood Research and Review. He called the meeting an "initial step" and a "proactive" move by the FDA.

"I think we have to take under consideration the advice we received today," Epstein told BioWorld Today, "and then establish our review criteria in anticipation of an application."

Elliot Cowan, who heads the product review branch of the FDA's Division of Emerging and Transfusion Transmitted Diseases, acknowledged a number of benefits of OTC testing, including anonymity and earlier intervention. But he hedged such positives relative to risks, most notably inappropriate use and potential suicides following positive tests, especially among teens, in the absence of counseling. However, Joseph Inungu, of Central Michigan University, allayed those concerns in presenting data showing that "notification of a positive HIV test does not appear to lead to a sudden and substantial rise in suicide death." Additional matters include supplemental tests for confirmation, as well as reporting requirements to government agencies and multilingual packaging.

Michels said it would be essential to show that individuals can accurately interpret instructions, effectively perform the test and interpret its results, and get linked to follow-up care. "Those are issues of primary importance," he said.

Sue Sutton-Jones, Orasure's senior vice president of regulatory affairs and quality assurance, outlined a study proposal designed to validate consumers' abilities, and also noted that OraQuick Advance "meets and exceeds" FDA requirements on sensitivity and specificity, with thresholds better than 99 percent on both counts.

"One wouldn't expect to see any change in that accuracy," Michels added. "It's the same device."

But committee members were concerned with false readings, which could result from its use too close to exposure, as there is a post-infection window before antibodies are present. That could lead to false-negative readings, and other committee members worried over false-positives, as well.

Also, pessimism arose during the meeting's public comment period, when Elliott Millenson, who founded a company on what eventually became the first FDA-approved home blood collection product for HIV testing, charged that nine years of delays before its clearance were "politically motivated." He said AIDS activists originally lobbied against the tests, while clinics feared the financial consequences of home testing.

"Past actions affect future decisions," he cautioned, and others warned that it could be three to five years before the FDA takes action on an OTC HIV diagnostic product.

These days, the FDA already is under fire over accusations of politicking a regulatory matter related to an OTC application for the contraceptive product Plan B, the so-called "morning-after pill." Current fallout includes a lawsuit from the manufacturer, high-profile inquiries on Capitol Hill and top-level staff resignations at the FDA over the agency's failure to act on the application to date.

But there was overwhelming public support voiced during the hearing. It's a market, Millenson predicted, that could quadruple the number of Americans getting tested.

The commercial opportunity could draw others. Already, three additional rapid HIV tests have FDA approval in the hospital or other laboratory settings and compete with OraQuick Advance in those markets. One, the serum-based Reveal test, from Medmira Inc., already has OTC status in Hong Kong.

That company, then, has a vested interest in the FDA's attitude, and several of its executives attended the advisory meeting. Giles Crouch, Medmira's vice president of sales and marketing, noted that while OTC status clearly could benefit public health, he cautioned that from a business standpoint, companies should not expect the products to fly off the shelves because of myriad social stigmas attached to HIV testing. He told BioWorld Today that OTC sales would likely represent only about 8 percent of Reveal's overall sales. Medmira, of Halifax, Nova Scotia, recorded C$389,000 in total product sales in their fourth quarter, ended July 31.

But for OraSure, whose product received FDA approval a year and a half ago, it has quickly boosted the company's total revenues. Those figures grew to about $17.4 million in the second quarter, and OraQuick Advance sales totaled about $4.6 million during that period.

On Friday, shares in OraSure (NASDAQ:OSUR) gained 54 cents to $11.05 while Medmira's stock (CDNX:MIR.V) dipped C$0.05 (US$0.04).