AEGiS-PRn: (PRn)FDA Notifies Epitope Oral HIV Confirmatory Test is Approvable

Important note: Information in this article was accurate in 1995. The state of the art may have changed since the publication date.

(PRn)FDA Notifies Epitope Oral HIV Confirmatory Test is Approvable

PR Newswire - 26 December 1995

BEAVERTON, Ore., Dec. 26 /PRNewswire/ -- Epitope, Inc. (AMEX: EPT) today announced that it has received notification from the U.S. Food and Drug Administration (FDA) that a premarket approval application (PMA) seeking permission to market its Western blot confirmatory test for use in HIV-1 testing with the company's OraSure(R) oral specimen collection device is approvable.

The approvable letter states that the FDA will issue an approval order after additional information has been submitted, reviewed and deemed acceptable, and upon successful completion of a facilities inspection. The company and agency representatives are already in contact to schedule the inspection. Epitope does not anticipate any difficulty in promptly submitting the requested information.

"The FDA determination that the PMA for a confirmatory test using an oral specimen is approvable represents a significant milestone in our efforts to offer reliable HIV testing without blood or needles," said Adolph J. Ferro, president and chief executive officer. "The ability to offer an HIV testing system based solely on an oral specimen will result in broader access to HIV testing."

Use of Epitope's oral specimen HIV testing system by life insurance underwriters is growing. Epitope has marketed the system to insurance underwriters since receiving FDA approval in December 1994.

Availability of confirmation from the same oral specimen is expected to further expand their used of the system.

SmithKline Beecham (SB) is Epitope's marketing partner for OraSure. Upon receipt of approval of the OraSure confirmatory test, SB plans to introduce OraSure HIV to a broad range of professional diagnostics markets.

Epitope is a biotechnology company that develops and markets medical diagnostic products and, through its agricultural units, superior new plants and related products.

CONTACT: Gus Allen or Mary Hagen of Epitope, 503-641-6115

Copyright (c) 1995/PR NewsWire. Reproduced with permission. Reproduction of this article (other than one copy for personal reference) must be cleared through the Permissions Desk, PR Newswire, 810 Seventh Avenue, New York, NY 10019.

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