Digene test clears a key hurdle at FDA Ruling could mean $40 million a year

Health care

September 05, 1997|By Mark Guidera | Mark Guidera,SUN STAFF

Beltsville-based Digene Corp. said yesterday that the Food and Drug Administration has approved use of its test for a common sexually transmitted disease as a follow-up test to determine if women with inconclusive Pap smear results are at risk for cervical cancer.

"This is really big for us," said Digene's president, Evan Jones. "We expect this development to have a major impact on revenues."

Should the managed care industry adopt Digene's HPV test as a follow-up screen for cervical cancer, it could generate up to $40 million annually for Digene, according to UBS Securities, which follows the company.

The company hopes that the decision moves it closer toward its goal of winning FDA approval of its test for Human Papillomavirus, or HPV, as a primary screening test for cervical cancer in the United States, Jones said.

Medical experts have determined that HPV, which is sexually transmitted, plays a strong role in causing cervical cancer, and its presence is considered a powerful indication that a woman has or will develop cancerous lesions.

The FDA said clinical testing services may use the same sample taken from a woman's cervix for a Pap smear test and retest the sample for HPV using Digene's DNA-based test for that disease.

The FDA approval only extended to retesting for HPV in conjunction with a Pap smear test marketed by Cytyc Corp. of Boxborough, Mass. The companies struck a joint marketing agreement in 1996.

The FDA said the follow-up test using Digene's HPV product can be performed only if a woman's Pap smear test result comes back inconclusive, or "borderline."

In raw numbers, Jones noted, the National Institutes of Health lTC has estimated that there are between 2.5 million and 5 million inconclusive Pap smear results annually in the United States.

The HPV test can't be marketed in the United States as a primary test for cervical cancer, although Jones said his company has such approval in Europe and South America and plans to seek such approval from the FDA in the future.

Currently women whose Pap smear tests are inconclusive undergo either another Pap smear test or an invasive procedure called a colposcopy. This involves the physician examining the cervix with an instrument for signs of abnormal cells or lesions.

Pap smear tests, which are between 60 percent and 80 percent accurate in diagnosing cervical cancer, generally cost about $30 each, while the 100 percent conclusive invasive exam can cost more than $300, experts said.

The HPV test, which is about 92 percent accurate in diagnosis, costs between $50 and $100, Digene said.

Pub Date: 9/05/97

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