OraSure Plans Counseling Service for Rapid HIV Test

OraSure Technologies Inc. (Bethlehem, PA) has taken another step toward seeking FDA approval for home use of its OraQuick Advance rapid HIV test. In March, the company announced that it had contracted the Constella Group LLC (Durham, NC) to design a counseling and referral service as an integral component of the consumer version of the test. For the past five years, Constella has operated a nationwide HIV-AIDS clearinghouse call center for the Centers for Disease Control and Prevention (CDC; Atlanta).

"We have initiated design work on a consumer counseling and referral system and are pleased to have Constella on board to complete the process," said Douglas A. Michels, president and CEO of OraSure. Citing its extensive experience with the CDC HIV-AIDS hotline, Michels said Constella was "ideally suited to help develop a robust, state-of-the-art, and fully compliant consumer counseling and referral system."

Chris LeGrand, president of Constella's public sector business, said, "Like OraSure, we are committed to helping individuals both understand their HIV test results and receive immediate information on accessing life-saving treatment and care services."

OraSure said the counseling service would offer phone and Web site access 24 hours per day, seven days per week, to assist consumers who use the OraQuick test and to provide medical referrals to consumers when needed.

During the past year, OraSure has been conducting clinical studies and developing new packaging and labeling. The company describes the incorporation of a consumer counseling and referral system as "a critical component of the clinical development of this product." The actions are seen as OraSure's response to recommendations made by FDA's blood products advisory committee at a meeting in March 2006.

This summer, the company expects to begin trials designed to demonstrate that inexperienced users can properly handle the oral-fluid version of its 20-minute test. "The studies will be designed to validate the ability of an untrained user to perform the test, to understand the instructions for use, to interpret the test result correctly, and to be able to follow the instructions after they've conducted the test," Michels said.

Following the completion of additional clinical studies, which are scheduled through 2008, OraSure plans to apply for FDA approval for consumer-based, nonprescription sales of OraQuick. CEO Michels expects the studies to cost about $10 million.

FDA approved the OraQuick Advance for use in hospitals, clinics, and other medically supervised settings in 2002. The professional version of the test costs between $15 and $17. OraSure has not indicated the expected cost of the over-the-counter version.

According to the company, the test can detect HIV-1 and HIV-2—the two strains of the virus that can infect humans—with greater than 99% accuracy. However, in 2006, multiple testing centers in California, New York, and Washington, DC, reported a sudden increase in false positives, which resulted in temporary discontinuation of the product's use in several settings.

Responding to the reported incidents of false positives, Michels said, "We've conducted an exhaustive assessment of how the product's performing in the field. We've collected information from more than 35 states. All of the data indicate that the test is performing with a specificity in excess of 99.8%, which is completely consistent with our U.S. FDA-approved package-insert claims."

A CDC study supported OraSure's assertion that the product performed as advertised. Bernard Branson, MD, a medical epidemiologist with the agency, said, "Excessive false positives at these sites appear to be related to unidentified site- or host-specific factors." Branson concluded that he found no evidence for a lot-related or device problem.

OraSure, which notes that there are 40,000 new HIV cases in the United States each year, says there is strong demand for an at-home test. "Our market research indicates that there are privacy concerns among consumers, and that they would purchase an HIV test over the counter if it was available," Michels said.

Other diagnostics companies either considering or readying their HIV products for at-home use in the U.S. market include MedMira (Halifax, Nova Scotia), Inverness Medical Innovations Inc. (Waltham, MA), Chembio Diagnostic Systems Inc. (Medford, NY), StatSure Diagnostic Systems Inc. (Framingham, MA), and Trinity Biotech (Bray, Ireland).

© 2007 Canon Communications LLC

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