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Test Maker Gets A Lift From FDA.(HEALTH & MEDICINE)(UNDER THE MICROSCOPE)
Byline: GLORIA LAU
Digene Corp
Gaithersburg, Md.
digene.com
For Digene Corp., the year brought good news. Its potential market of $60 million blossomed into $500 million.
Here's how it happened: This summer the company won Food and Drug Administration approval to market its test for the human papillomavirus, or HPV, for use with every Pap smear requested by women over 30.
Before this, Digene could market the test for use as a follow-on exam for women whose Pap smear results came back inconclusive -- only 6% of all Paps.
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