Digene Corp. said yesterday that the Food and Drug Administration has approved use of its second-generation test for a common sexually transmitted disease as a follow-up to determine if women with inconclusive Pap smear results are at risk for cervical cancer.
The test approved yesterday, said company officials, is a marked improvement over its currently available screening for human papillomavirus because it detects all HPV types. There are 70 HPV types; 13 are known to cause cancer.
As with the Beltsville-based company's first-generation test, approved by the FDA in 1997, the new HPV test was approved by the regulator only for use as a follow-up to abnormal Pap smear results, which are considered "inconclusive" or "borderline." It cannot be used as a primary screening tool for cervical cancer.
Medical experts have determined that HPV, which is sexually transmitted, plays a key role in causing cervical cancer, and its presence is considered an indication that a woman has or will develop cancerous lesions.
While about 3.5 million Pap smear exams yield inconclusive results annually, only about 10 percent of them actually have underlying high-grade lesions that indicate cervical cancer risk. Women with inconclusive exams must have Pap smear exams and sometimes an invasive procedure to make a final determination, said Kelley Mullaney of the American Medical Women's Association in Alexandria, Va.
About 15,000 women annually are diagnosed with cervical cancer in the United States and about 5,000 die each year of the disease, which health authorities say is highly preventable with good screening.
Digene's president, Evan Jones, said the company's new test should provide a powerful tool for physicians and help cut health care costs because tests that come back negative are 99 percent accurate, based on clinical trial results. The company hopes to convince health insurers that sensitivity can help trim unnecessary treatment.
Digene is banking on the new HPV test to be widely embraced for coverage by health insurers in the United States. That, said Jones, would be a big step in the company's effort to gain a significant share of the estimated $70 million market for exams to inconclusive Pap smear results.
"We see this approval as very significant for the company" said Jones.
Mullaney at the AMWA said Digene's HPV test is the only one of its kind on the market and when used as a follow-up to the Pap exam provides almost 100 percent accuracy for a diagnosis.
Women's health physicians and health insurers, said Mullaney, have been awaiting the second-generation test's U.S. approval. The Digene test, she said, could help eliminate unnecessary testing and anxiety for women with abnormal Pap results.
Digene expects its new HPV test kit to be available by May, and to sell for about $20.
Doctors offices would send a Pap smear sample to a reference laboratory for follow-up testing with Digene's kit. Test results would be available within several days, said Jones.
The company, said Digene Chief Operating Officer Charles M. Fleischman, believes that its new test will offer another advantage to physicians and patients: It can screen for several sexually transmitted diseases.
Digene, which reported Dec. 31 a $4.8 million net loss on sales of $7.6 million for the first six months of its fiscal year, had hoped its first-generation HPV test would be a money maker.
But the test has not generated strong sales in the U.S. market since being approved by the FDA in September 1997. Fleischman said U.S. sales of that test have not been as strong as initially expected because many insurance companies have elected not to cover its cost.
The company's growth in sales revenue -- up 39 percent for the first six months of the fiscal year -- is attributed largely to sales of the improved HPV test in European countries, where it has been embraced as a cervical cancer screening tool, said Fleischman.
The company, he said, has been told by several large U.S. health insurers that they would be more receptive to covering Digene's improved HPV test.
This year, he said, Digene plans to launch human clinical trials to gather data for its planned application for FDA approval to market the HPV test as a primary screen for cervical cancer.
Shares in the Beltsville biotechnology firm closed yesterday at $8.25, up 43.75 cents.
Pub Date: 3/20/99