Digene looks for niche for cancer test

Screening method may complement, if not replace, Pap smear

June 06, 1999|By Mark Guidera | Mark Guidera,SUN STAFF

At health clinics operated by Omnia Inc. in Chicago and the Northeast, women are routinely tested for cervical cancer using that stalwart of gynecology, the Pap smear, and a new, more sensitive test that many medical experts believe could one day replace it.

Philadelphia-based Omnia, which manages private gynecology practices serving 400,000 women, is the first managed care organization in the United States to use the new test in conjunction with the Pap. But other managed care groups, most notably Kaiser Permanente, one of the nation's largest, are considering following the same protocol.

"I think it is only a matter of time before this test is broadly used as an adjunct to the Pap, if not a replacement," predicts Dave Mura, a Rochester, N.Y., investment banker with Schneider Securities Inc., which holds shares in Digene Corp.

Known as the Hybrid Capture Human Papillomavirus (HPV) test, it's made by Digene, based in Beltsville.

Digene's test detects the presence of human papillomavirus DNA. The company says tests that come back negative for HPV have a 99 percent accuracy rate.

Medical studies have determined that 13 of the 70 strains of HPV, a common sexually transmitted disease, are triggers for cervical cancer, and hence their presence is considered an indication that a women has or will develop cancerous lesions.

Digene has barred the door on competitors by landing patents on the seven most common cancer-causing strains.

Digene founder Evan Jones bought the DNA technology from Rockville-based Life Technologies in 1990 for $5 million. Previously, Jones, 41, had worked at Perkin-Elmer Corp., the genetics research equipment giant, where he helped launch its successful life-science research business before moving on to a venture capital outfit.

The Wharton School of Business graduate, who grew up working at a family-owned medical testing business in New York, had been shopping for diagnostic technology as a base for a new company that would focus on developing and selling DNA-based tests for treatable diseases.

With the technology, Jones also got Attila Lorincz, the scientist behind the molecular technology that would eventually lead to the HPV test breakthrough.

Lorincz recalls thinking after he had perfected the test that it was a superior way of screening for cervical cancer lesions and would prove an easy sell.

"I assumed the truth would prevail," said Lorincz.

In September 1997, the Food and Drug Administration approved use of the Digene test as a follow-up for women with inconclusive Pap smear results, and in March, the FDA approved a faster, easier-to-use second-generation test.

Analysts had expected the original nod from the FDA to spur widespread adoption of Digene's HPV test, an event that would have triggered a windfall for the small company.

But it hasn't been that easy.

For one, said Jones, managed care has been slow to add the test to its reimbursement schedules.

The company is hopeful that its second-generation test will be embraced by health insurers and managed care. Empire Blue Cross Blue Shield in New York, which has more than 3 million members, recently announced that it would cover costs of the test.

Also, the Pap remains deeply entrenched in Western medicine.

"The Pap is an icon of American medicine. People don't part with icons easily," said Jones.

And with good reason.

Developed by the American medical scientist George N. Papanicolaou and introduced almost 50 years ago, the test has helped lead to a dramatic decline in not only cervical cancer but deaths from the disease.

As a result of the widespread use of Papanicolaou's test, new cases of cervical cancer have dropped 40 percent in the United States in the past 25 years while cancer deaths have declined almost 80 percent to 5,000 a year, according to the American Medical Women's Association.

Rose Marie Gatcha, cytology manager for Memorial Sloan-Kettering Cancer Institute in New York, testified before Congress recently that the Pap is "the most effective cancer screening test in medical history."

But, as medical experts note, the Pap does have its limitations.

Industry analysts say the Pap is antiquated technology, although new automated Pap tests have begun to hit the market and improve reliability.

It also takes a sophisticated level of expertise to perform a manual exam correctly.

The Pap is performed by collecting a sample of cells from a woman's cervix. The sample is then smeared onto a microscope slide. A trained specialist known as a cytologist reviews the slide, looking for subtle changes in the cells that are telltale signs of a precancerous or cancerous stage.

The problem: Cytologists don't always spot signs of cancer or lesions.

In the United States such inconclusive readings occur about 7 percent of the time, or in about 3.5 million cases. Health experts estimate that the Pap misses 30 percent of women with cervical cancer -- "false negative" results.

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