OraSure Technologies (Bethlehem, Pennsylvania), developer of the OraQuick Advance Rapid HIV-1/2 Antibody Test, on Friday expressed optimism concerning recommendations made earlier in that day by the Blood Products Advisory Committee (BPAC) of the FDA and the company's ability to carry out follow-on clinical trials analyzing home use of the HIV test kit.

The BPAC meeting included a discussion of proposed studies to support the approval of over-the-counter (OTC) HIV test kits, and the committee then agreed to a proposal by FDA's proposals for studies leading to approve use of the test in the home.

In a conference call following the meeting, Doug Michaels, president of the company, said he was "extremely encouraged" by the discussion and recommendations of the committee and that its feedback was "extremely valuable." He also noted "unequivocal support from the public health and hospital community."

Key to the whole effort and approval for home use will be the ability of test users to understand and administer the test correctly and then, given the psychological implications of results indicating infection, their ability to carry out rational follow-on evaluation of the test.

Because the test for HIV infection is already FDA-approved as a prescription product, the company, Michaels noted, does not need to do a Phase I trial but that it "will move directly to Phase II studies."

This will involve, Michaels said, "untrained users, focused primarily on the understanding of the materials provided with the product to evaluate the untrained users' ability to properly collect the specimen, perform the test and interpret the test results."

The FDA, he noted, proposed three levels of test interpretation studies: "self testing, testing with simulated results . . . and contrived devices, put in front of the untrained user – negative, low positive and strongly reactive specimen."

The third phase, he said, will involve "assessment of the information provided in the kit, the clarity of that information, . . . testing the user's understanding of how they can best be connected to care and, maybe, a post-market surveillance component."

Michaels said that what the FDA committee had recommended was "by and large what we anticipated would be required to design our clinical studies originally."

He said that a key element of these efforts will be follow-on services and counseling by telephone as "part of the packaging and instructions for use – [how] to get in touch with appropriate healthcare professionals."

He said that counseling will be the same as that generally provided by public health people and that they will be relied on to "define and refine these scripts that will be used as part of the counseling process." This will be "what has been used in other community-based organizations and clinics that do this on a daily basis."

He said that the company will proceed to meet with the FDA "as rapidly as possible" to develop trial specifics, with his prediction that the studies "will launch some time this summer – no later."

Reporters questioned Michaels about the potential barrier of additional costs for the studies and suggested there had been some delays in getting to this process.

He declined to see negatives in either.

"We weren't disappointed at all. The outcome of today was very much in line with our expectations," he said. And he noted that the studies proposed were very similar to what the company had proposed last November.

He also indicated there was no great delay in moving forward with the trial plan. He noted that the oral fluid form of the test was launched in late 2004, that the company then approached the FDA in June of last year "about the requirements for an OTC approval" and that it now had "pretty clear guidance in terms of a path forward."

"My experience is that this is pretty good for the FDA," Michaels said. "In the general scheme of things it's moving along pretty well."

The company then on Monday issued a statement saying that it "look[s] forward to the day, hopefully in the near future, when millions of individuals will be empowered to know their HIV status through greater access to rapid testing. We will continue to work in partnership with the FDA and other members of the healthcare community to make that a reality."

OraQuick ADVANCE is the first and only FDA approved and CLIA- (Clinical Laboratory Improvements Amendments Act of 1988) waived rapid point-of-care test that can detect antibodies to both HIV-1 and HIV-2 in 20 minutes, using oral fluid, finger-stick or venipuncture whole blood or plasma specimens.

The Centers for Disease Control and Prevention and the Substance Abuse and Mental Health Services Administration have deployed over 1 million OraQuick tests in various public health, drug treatment and outreach settings throughout the country. OraQuick is also used by hospitals, state departments of health, clinics, community-based organizations, and college/university health centers throughout the country.

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