FDA withholds OK on Digene test expansion

Agency wants more data on exam's clinical impact

April 03, 2002|By Julie Bell | Julie Bell,SUN STAFF

Digene Corp. said yesterday that the Food and Drug Administration has informed the company it won't approve expanded use of Digene's cervical cancer test without additional information.

The FDA's request for additional information follows a recommendation made last month by an FDA advisory panel, which voted 6-2 to recommend expanded uses be approved as long as a number of conditions were met. Among other things, the panel said the company should demonstrate the test has an impact on clinical outcomes.

"We don't expect to have to do additional clinical work," Digene President Charles M. Fleischman said, noting "additional analysis of existing data is what was discussed at the panel" in March.

Digene's test currently is approved in the United States only as a means of checking or clarifying a Pap test. The company now is seeking to have the test used as a primary screening method, in conjunction with the Pap test, in women age 30 and over.

Fleischman said he didn't expect the FDA's request to have an impact on Digene's acquisition by Cytyc Corp., a Boxborough, Mass. company that already co-markets Digene's cervical cancer test along with its ThinPrep Pap test.

Cytyc has offered to acquire Digene for $76.9 million in cash, plus Cytyc stock worth $588.3 million at yesterday's closing price of $25.58. Digene shareholders have until midnight April 11 to tender their shares in favor of the offer. The agreement calls for Digene shareholders to get 1.969 shares of Cytyc common stock for every Digene share held.

Digene shares lost $2.35 yesterday, or 6.4 percent, to close at $34.15 on the Nasdaq stock market.

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