Digene receives FDA approval for combined STD test

U.S. sales market estimated at $120 million

Medical testing

March 08, 2000|By Mark Guidera | Mark Guidera,SUN STAFF

Digene Corp. said yesterday that it has received clearance from the U.S. Food and Drug Administration to market a combined test for two common sexually transmitted diseases in women.

Digene's test will be the first available in the United States that can screen for gonorrhea and chlamydia in women at the same time. Currently, tests for the diseases must be performed separately. Digene's Hybrid Capture II test is designed to diagnose the two diseases from a single swab sample from a woman's cervix. The test recognizes DNA of the bacterium that causes the two diseases.

Shares in the Gaithersburg-based company, which have risen more than 800 percent since this time last year, closed yesterday at $53.50, shedding $1.50. In early trading yesterday, shares hit a 52-week high of $58.50 before declining.

The company and Abbott Laboratories, which has rights to market the test, are hoping the reliability and convenience of the combination test makes the product attractive to doctors, health insurers and testing laboratories. ABN-Amro, a Chicago-based investment adviser, told investors in a report this month on Digene that a combined chlamydia and gonorrhea test should provide the company and Abbott with a significant marketing advantage over competitors' individual tests.

Testing giant Becton-Dickinson and privately held Genprobe Inc. sell individual DNA-based tests for the diseases. Vandana K. Bapna, a biotechnology analyst with Offutt Securities in Hunt Valley, estimated in November that the potential market for a single test for the two diseases at $120 million in the United States. In Europe, where Digene combination test is sold, she estimates a potential $80 million sales market.

Digene, which lost $2.7 million on sales of $10.5 million for its first six months ending Dec. 31, said it will manufacture the test at its new facility in Gaithersburg and ship them to Abbott for distribution.

The company said it expects to generate $5 in revenue for each combination test sold to Abbott, a spokeswoman said. The cost to customers has not been set.

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