WASHINGTON -- Epitope Inc. has denied charges made Mondayon ABC TV's World News Tonight that the Food and DrugAdministration is investigating the company's marketing of asaliva-based HIV test collection device for use by insurancecompanies.
ABC claimed that FDA officials told Epitope "that it is illegal toship unapproved medical test kits across state lines. ... IfEpitope does not stop marketing the test kits, they could beseized and the company fined."
FDA officials supported Epitope's contentions, saying that theagency has not launched a formal investigation and has notcommunicated with Epitope.
The Epitope saliva collection device, called OraSure, consists ofa small, absorbent pad on a "lollipop" stick that is speciallytreated to allow antibodies to be absorbed into the pad andthen efficiently removed by centrifugation. Epitope ismarketing OraSure through Home Office Reference LaboratoryInc. of Kansas City, Mo., which performs analyses solely forinsurance companies that use the tests to screen insuranceapplicants. Epitope and Home Office contend that FDA approvalis not required for devices used in insurance screening, exceptin some states.
"We are doing a thorough review of the situation to see if it issomething that should involve the FDA," an agency spokesmantold BioWorld. OraSure is currently undergoing clinical trials,and Epitope plans to apply for FDA approval of the product asan HIV test, Epitope said.
Epitope stock (AMEX:EPT) lost $1 on Tuesday, closing at $16.25.
-- Steve Usdin BioWorld Washington Bureau
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