The Food and Drug Administration has sent Epitope Inc. awarning letter stating that Epitope's OraSure AIDS test is anunapproved diagnostic product and that the company shouldinitiate a recall immediately.
"There has been concern that this test has been widelydistributed and has not received approval from the agency,"FDA spokeswoman Faye Peterson told BioWorld. Peterson saidEpitope has 48 hours to respond. If the company fails to do so,"the FDA has seizure authority and presumably would use it."
Epitope President Adolph Ferro, in a statement issued lateFriday, said, "We intend to respond directly to the FDA Mondaymorning, July 1, to clarify the FDA's position and tocommunicate the company's belief that current uses of theOraSure device by the insurance industry meet all legalrequirements."
"We will continue to make every effort to cooperate with theFDA," he said.
Although OraSure is being used only by the insurance industry,"it's still a diagnostic test," Peterson said. "It has claims to beuseful to diagnose disease, so it comes under the devices anddiagnostics law."
Epitope filed in May for FDA marketing approval of OraSure, asaliva-based HIV test collection device. Clinical trials ofOraSure compared results of saliva tested for the AIDS viruswith blood-based tests.
OraSure consists of a small, absorbent pad on a "lollipop" stickthat is specially treated to allow antibodies to be absorbedinto the pad and then efficiently removed by centrifuge.
Use of OraSure by insurance companies became an issue in lateApril after ABC News said the FDA was investigating thecompany's marketing of the product. The FDA at that time toldBioWorld that it had not launched a formal investigation ofEpitope. However an agency spokesman said, "We are doing athorough review of the situation to see if it is something thatshould involve the FDA."
At that time, Epitope of Beaverton, Ore., was selling OraSurethrough Home Office Reference Laboratory Inc. of Kansas City,which performs analyses solely for insurance companies thatuse the tests to screen insurance applicants.
Epitope stock (AMEX:EPT) closed at $18.50, down 13 cents,prior to the announcement.
-- Karen Bernstein BioWorld Staff
(c) 1997 American Health Consultants. All rights reserved.