Digene's Cancer Test Is Reliable, Study Finds

A major study of Digene Corp.'s newly approved laboratory test for cervical cancer reported that it detected 100 percent of cervical cancer and precancerous changes in women over 30, which virtually assures a woman who tests negative that she does not have and is unlikely to soon develop cancer, the company said.

The US Food and Drug Administration recently approved the Gaithersburg-based corporation's two-in-one test, called the DNA with Pap, which combines the standard Pap with a genetic test for 13 strains of human papillomavirus, a common STD that causes 99 percent of cervical cancer cases. The Pap, a visual examination of cervical cells, can miss signs of cancer. But when doctors use it with a test for HPV, they significantly increase their odds of detecting and treating a disease that kills at least 4,000 American women a year, medical experts say.

The findings show Digene's HPV test, when used alone, detected 97.8 percent of cancers and precancerous conditions, far surpassing the reliability of traditional Pap. "HPV testing is showing more consistency and sensitivity over time," said Diane Solomon, director of cancer prevention at the National Cancer Institute, who called the results "impressive" but cautioned that many of those who test positive with the combined test will not develop cervical cancer. Millions of women carry HPV but it only poses a danger to those whose infections persist.

The study, "Inclusion of HPV Testing in Routine Cervical Cancer Screening for Women above 29 Years in Germany: Results for 8466 Patients," was published this week in the British Journal of Cancer (05.19.03;88(10):1570-1577).

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