FDA gives Digene OK to sell viral test in U.S.

Maryland Watch

October 14, 1998

Digene Corp. said yesterday that it received marketing clearance from the U.S. Food and Drug Administration for its DNA test to detect cytomegalovirus, which can cause infections of the eye, gastrointestinal tract and other areas.

The Beltsville company said the test will be marketed to doctors to diagnose CMV infection in patients who have had organ and bone-marrow transplants and in people with HIV or AIDS. CMV commonly infects people whose immune system has been compromised.

Evan Jones, Digene's president and chief executive officer, said the test is the first product in Digene's blood virus testing business to get marketing clearance in the United States.

Jones said industry estimates peg the potential market for a new CMV test at $120 million to $125 million.

The test kit, which the company expects to sell for between $25 and $30, is twice as sensitive to the virus as the currently used culture test and can yield a result in one day, Jones said. The culture test can take up to one month.

Shares of Digene rose 81.25 cents yesterday to close at $4.875.

Pub Date: 10/14/98

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