An FDA advisory panel late Friday split its vote on whether torecommend marketing approval for Epitope Inc.'s OraSuredevice for collecting oral specimens for anti-HIV antibodytesting. Earlier that day, the Beaverton, Ore., company issued a"halt trading" order on its stock (AMEX:EPT) while it waited forthe panel's opinion.

The company's stock was off $3.63 a share on Monday, closingat $16.88.

OraSure is a device for collecting oral samples -- cheek tissueand saliva -- to be used in the ELISA screening test for HIV-1,as well as a Western blot confirmatory test. It is designed todetect IgG antibodies, which apparently leak into the mouthfrom mucus membranes.

"The (FDA) committee raised issues related to collectionsettings, sample verification and product labeling," said AdolphFerro, the company's president and chief executive officer, "andwe are confident that these issues can be satisfactorilyresolved. We will work closely with the FDA to that end."

The panel also dealt with issues concerning the test's specificityand sensitivity compared with tests that assay blood samplesfor the presence of viral antibodies. And according to AndrewGoldstein, Epitope's senior vice president of productdevelopment, who was at the meeting with FDA, Jay Epstein,the committee's chairman, declared that the oral sample is"slightly less sensitive than blood."

But "the panel consensus was that sensitivity is not an issuecritical to approval," Goldstein told BioWorld. "We still haven'tgotten to the ultimate resolution as to what those numbersshould be." Overall, Goldstein said, "we were gratified that wecame away understanding what the key issues are, and webelieve they're all addressable."

Jim McCamant, editor of the Berkeley, Calif. based MedicalTechnology Stock Letter, concurred, telling BioWorld, "It soundslike there's a fair chance they'll get approval, but there may besome labeling restrictions."

"Final action (on approving OraSure) is due in March of 1993,"Goldstein told BioWorld.

This isn't the first time that Epitope and FDA have gone aroundabout this particular product. In July 1991 FDA demanded thatEpitope and its distributor, Home Office Reference LaboratoryLab Inc. of Lenexa, Kan., cease marketing OraSure, which theywere doing without FDA approval. (FDA also reprimanded othercompanies that had been selling unapproved saliva- or urine-based AIDS tests at the same time.) Epitope had been sellingthe kits to insurance companies for use in screening applicantsfor evidence of antibodies to HIV. The companies based theirdecision to market OraSure on the fact that "the definition of amedical device is for diagnosis or mitigation of a disease. Thistest is being used for a screen."

FDA told the two companies that they were "incorrect" inbelieving that the product didn't need official sanction. At thetime, Epitope's Ferro told BioWorld that the FDA's action "hasnothing to do with whether saliva testing is accurate. FDA issaying it is only acceptable (to use saliva-based tests forinsurance screening) after you have an approved PMA (productmanufacturing application). We submitted a PMA in May."

And last June, Epitope's stock took a dive because FDA reportsrelated to OraSure -- in particular an establishment inspectionreport (EIR) -- were released prematurely. The EIRs werereleased in response to a request filed under the Freedom ofInformation Act, according to Amanda Pedersen, the FDA'schief mediator and ombudsman. She told the company, "Weregret that the release of the EIR, which occurred prior to itsevaluation by officials of the Center for Biologics Evaluation andResearch, may have caused confusion among persons outside ofthe agency about the status of your product."

-- Jennifer Van Brunt Senior Editor

(c) 1997 American Health Consultants. All rights reserved.

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