OraSure says FDA set clinical study requirements for home-use HIV test kits

By Elaine Rigoli

Tampa, Fla., March 13 - OraSure Technologies, Inc. issued a statement Monday following a meeting of the blood products advisory committee of the Food and Drug Administration held Friday.

The BPAC meeting included a discussion of proposed studies to support the approval of over-the-counter home-use HIV test kits. At the conclusion of the meeting, the committee agreed to a proposal by the FDA setting clinical study requirements for approval of a home-use HIV test kit.

"We are extremely encouraged by the proposal put forward by FDA and the endorsement of that proposal by the committee. This has provided significant clarification of the regulatory pathway for approval of an over-the-counter rapid HIV test," said Douglas A. Michels, president and chief executive officer, in a statement.

"The discussion and feedback from the committee and the public has been extremely valuable as we take the next steps in bringing our OraQuick Advance test over the counter and we are very pleased with the strong support received from the public health and hospital community for an over-the-counter rapid HIV test."

OraSure said it plans to begin required clinical studies as soon as possible.

OraSure develops oral fluid specimen collection devices using proprietary oral fluid technologies, in-vitro diagnostic tests and other medical devices. The company is based in Bethlehem, Pa.

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