WASHINGTON -- The Food and Drug Administration has vowedto prevent the marketing of unapproved AIDS tests andcollection kits, including all saliva- and urine-based tests.
In a statement, the FDA on Thursday said that "to date no AIDSantibody test kit using any human body fluid other than wholeblood, dried blood spots, plasma or serum has been approved.The promotion of AIDS antibody tests for use with any otherbodily fluid violates the federal Food, Drug and Cosmetic Act."
The FDA noted that Epitope Inc. and its distributor, HomeOffice Reference Laboratory Inc., have "agreed to FDA demandsthat they cease marketing OraSure saliva collection kits forAIDS antibody testing. The kits had been marketed without thenecessary FDA approval. Home Office Reference Laboratorywill retrieve the unapproved devices that have been sent toinsurance companies for use in screening applicants forevidence of the antibody to the AIDS virus."
The FDA action definitively places insurance screening testingunder the agency's regulatory umbrella. Epitope and othercompanies were marketing saliva-based AIDS tests for use inscreening insurance applicants. Epitope of Beaverton, Ore., andHome Office of Lenexa, Kan., agreed to stop marketing the kitson July 5.
While Epitope and Home Office were specifically cited by theFDA, other companies have been affected by the ban. GeneticSystems Corp. suspended sales of a saliva kit following theFDA action against Epitope, according to Carl Bowers, seniormarketing manager of the Seattle company.
Bowers said the company was distributing a saliva collectiondevice manufactured by Saliva Diagnostic Systems for usewith Genetic's Elisa HIV screening test.
"We worked with (the saliva test) as a competitive response toEpitope and Organon Teknika and Home Reference Labs. We haveabout half the HIV testing market for insurance purposes,"Bowers said. "We had already decided not to distribute anymore saliva tests. We had our questions about saliva -- thequality of the sample, viability of the collection device itself,stability of the sample. But you need to respond to yourcustomer's perceived needs, and the insurance industry feltthat it would drive testing up and cost down."
Al Ferro, Epitope's president and chief executive, told BioWorldthat the FDA's action "has nothing to do with whether salivatesting is accurate. FDA is saying it is only acceptable (to usesaliva-based tests for insurance screening) after you have anapproved PMA (premarket approval). We submitted a PMA inMay."
If the PMA application is approved, Epitope will file with theFDA for approval for use of the device with its EPIblot westernblot HIV test and with Organon Teknika's Elisa test, accordingto Ferro. Organon Teknika is based in Belgium.
Epitope stock (AMEX:EPT) closed at $16.13, down 25 cents, onThursday.
-- Steve Usdin BioWorld Washington Bureau
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