Epitope Inc. said Monday that it has extended for two years itsdistribution and supply agreements with Organon TeknikaCorp., which has exclusive worldwide distribution rights toEpitope's Epiblot Western blot AIDS confirmatory test kits.
Last week, the company filed a response to FDA comments onits marketing application for another AIDS test, the OraSureoral kit for detecting antibodies to the AIDS virus.
Last July, the FDA demanded that Epitope and its distributor,Home Office Reference Laboratory Inc. of Lenexa, Kan., ceasemarketing OraSure to insurance companies until the test isapproved.
Epitope's response last week included issues expected for anytest, such as sample stability. The company also responded toquestions on the ability of insurance agents to collect samples."They wanted us to demonstrate that a non-professional couldtake an adequate sample," said Gilbert Miller, executive vicepresident and CFO, "and we did."
Miller said the agency has 180 additional days to respond tothe application. It may refer the test to its Blood ProductsAdvisory Committee, or it could act to approve the test withoutsuch referral, Miller said. The FDA already has approved exportof the device to 13 foreign countries.
If the application is approved, Epitope will file for approval touse the device with the Epiblot test and with Belgium-basedOrganon Teknika's Elisa test as confirmatory tests that the viralantibodies are present.
Organon has been marketing the Epiblot kits since theirintroduction in 1987. Epiblot accounted for 54 percent ofEpitope's total revenues of $3.8 million for the year ended Sept.30, 1991. Shares of the Beaverton, Ore., company (AMEX:EPT)closed at $17.63, down 50 cents, on Monday. -- RF
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