Originally Published IVD Technology January 2006
INDUSTRY NEWS
FDA mulls OTC HIV testsThe day may come when over-the-counter (OTC) home-use tests for HIV are as readily available at local drug stores as pregnancy tests and blood glucose meters. However, IVD manufacturers and FDA regulators will need to resolve several issues before that time comes.
FDA’s Blood Products Advisory Committee (BPAC) held a meeting to discuss approaches to validating OTC home-use HIV test kits. The intent of the meeting was to seek input from the relevant stakeholders, such as the public health community, healthcare providers, consumers, and the IVD industry, on their perspectives on home-use HIV tests. During the meeting, the participants discussed a number of different issues including changes in HIV testing practices, counseling recommendations, and psychological and societal issues associated with HIV testing and OTC home-use test kits.
FDA was also seeking advice from BPAC on the conditions necessary to support approval of an OTC home-use HIV test kit. The committee considered the types of studies needed to assure test accuracy, test interpretation, and medical follow-ups based on educational materials and instructions provided to users in lieu of trained test operators and counselors.
The meeting was originally prompted several months earlier when OraSure Technologies Inc. (Bethlehem, PA) approached FDA about its interest in seeking OTC status for its OraQuick rapid HIV antibody test for use with oral fluid specimens. Based on this inquiry, FDA decided to convene a BPAC meeting to discuss the broader issues regarding OTC home-use HIV tests.
OraSure officials said they were pleased with the outcome of the meeting, and they looked forward to moving forward on the initiative with FDA.
“The ball is now in FDA’s court, to take the guidance from the meeting, interpret it, and translate it into discussions with sponsor companies like us,” says Doug Michels, president and CEO at OraSure. “We expect to meet with FDA as rapidly as possible to define the next steps and develop an agreed upon strategy for an application for OTC approval.”
However, FDA officials stated that the agency will take a cautious approach and did not intend to make any decisions or new policies during the meeting.
“We are here to listen to everyone’s thoughts, ideas, concerns, and recommendations and reevaluate our policies,” said Elliot P. Cowan, PhD, an official from FDA’s Center for Biologics Evaluation and Research who spoke at the meeting. “We will take all the information from this meeting back to the office and review it carefully with all of our staff involved in this issue. We will also review the meeting transcripts in detail before deciding on any next steps.”
In the meantime, OraSure is already anticipating what sort of information it may have to provide in order to get approval for an OTC home-use HIV test.
“We’re going to have to conduct studies that demonstrate to FDA that users can use the product per the instructions for use, and that individuals can interpret the results once the test is performed,” says Michels. “I’m sure we will also be asked to demonstrate that users can get connected to healthcare providers, counselors, or organizations that can perform confirmatory testing.”
Additional information can be accessed via BPAC’s Web site at www.fda.gov/cber/advisory/bp/bpmain.htm.
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