Epitope Inc. has formed a partnership with Sigma-Seiki Inc., amanufacturer of diagnostic equipment, to market its OraSurespecimen collection device in Japan.
Speaking before a meeting of the New York Society ofSecurities Analysts on Monday, Epitope's president and chiefexecutive officer, Adolph Ferro, said the company (ASE:EPT)owns 60 percent of a limited liability stock company, EpitopeK.K., established with Sigma-Seiki. The Japanese company filedan application for approval of OraSure in Japan several monthsago.
The terms of Epitope's agreement with Sigma-Seiki were notdisclosed.
OraSure consists of a pad on a stick that is placed between thegum and cheek for two minutes to collect oral fluid for HIVtesting. Kevin Crowley, Epitope's vice president of medicalproducts, said the device is safer for health professionals thancurrent blood tests for HIV since there is no chance ofaccidental needle sticks. Also, the oral fluid is more stable thanblood or plasma and can be stored for up to three weeks atroom temperature. The fluid is treated the same way as serumwhen applied to an HIV test kit.
The device is currently marketed in 10 countries, includingCanada, Thailand, Taiwan, Indonesia and England, for use inHIV screening. It is also used to detect cotinine, a marker fornicotine, by insurance companies that test to determine ifsomeone is a smoker. The device is available in the U.S. for thisindication.
Epitope filed a product license application (PLA) with FDA in1991 for using the product in HIV screening. Ferro said thecompany is meeting with FDA staff on Wednesday to discussremaining issues of the application.
Epitope of Beaverton, Ore., also has entered into agreementswith distributors in China, Thailand and Indonesia fordistribution of the device overseas. It has not yet beenapproved in China.
Ferro also said the company will issue warrants for distributionof 700,000 shares of common stock upon approval by the U.S.District Court in Portland, Ore. The warrants will entitlerecipients to purchase shares for $17.13 each. If all warrantsare exercised, Epitope would receive proceeds of almost $12million.
The shares were issued in a settlement of a class-actionshareholders unit that resulted in a $1.4 million non-cashcharge to net income in fiscal 1993.
Epitope's stock closed at $21.63 a share on Monday, down 37cents.1109EPITOPE
-- Brenda Sandburg News Editor
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