Executives at Neuromedical Systems Inc. thought they'd struck gold.
The U.S. Food and Drug Administration had just approved Neuromedical's PapNet, a computer system that reads Pap smears and points out abnormal-looking cervical cells that human screeners might miss.
With 60 million Pap smears done each year in the United States, Neuromedical executives thought they had it made.
It didn't turn out that way.
Three years later, Neuromedical can't get insurance companies to reimburse laboratories that use its system, despite FDA approval and research showing that the computer catches diseased cells that humans reading the Pap smear miss.
And this company, based in Suffern, a suburb north of New York, is not alone.
Fifty years after the Pap smear became the standard screen for cervical cancer, a new generation of tests and technologies is on the market. But like PapNet, most aren't covered by insurance and thus remain unknown by women and unused by their doctors.
The products, insurers say, are more expensive than traditional Pap smears and drain resources that would be better spent educating women to start getting regular gynecological checkups. Makers of the tests, many doctors and Wall Street analysts say insurers are impeding the first improvements to the Pap since 1948.
The issue has touched off a high-stakes debate about the future of the Pap smear.
Credited with cutting the number of cervical cancer deaths by 70 percent, the Pap smear has become one of the most respected and successful disease-fighting tools in history.
The test is "like a sacred cow," said Dr. J. Thomas Cox, who writes guidelines for the American Society for Colposcopy and Cervical Pathology, a group of gynecologists and obstetricians based in Hagerstown, Md. "People just can't see beyond it."
"If you've been collecting a Pap smear for 25 or 30 years the same way, you may need an awful lot of convincing to switch you to a new protocol," said Robert Michael, editor of an Oregon-based journal for laboratory executives. "Physicians are creatures of habit."
It is this familiarity with the traditional Pap smear, coupled with the lack of reimbursement, that makes it so difficult to get the new products accepted, say industry watchers and doctors, some of who have lobbied Congress for Medicare coverage of the new tests.
Even insurers admit the Pap smear is far from infallible. It misses problems about 20 percent of the time, according to the National Institutes of Health, usually because of poor cervical samples or difficulty reading the slides at the lab.
Named for Dr. George Papanicolaou, the pathologist who developed it, the Pap smear involves the physician scraping cells from the cervix, at the neck of the uterus, with a special spatula or brush. The cells are smeared onto a glass slide, sprayed with a fixative and sent to a lab, where a technician reads the slide under a microscope. It's been done that way since 1948.
But in the last five to 10 years, scientists have made major advances in cervical cancer research. With much of the code cracked, entrepreneurs began creating new products to improve the venerable Pap smear -- or even replace it.
Some, like PapNet and NeoPath Inc.'s AutoPap, use computers rather than human eyes to spot abnormal cells. Others, like ThinPrep by Cytyc Corp. and Prep by AutoCyte Inc., treat the cells with a liquid to remove blood and mucus that can hide cancerous changes. Still others, like Hybrid Capture by Digene Corp., read a woman's DNA to see if her abnormal cells are likely to progress into cancer.
And on the horizon: vaccines against the human papilloma virus, which causes cervical cancer. Drug companies say the vaccine would go to adolescent girls before they become sexually active.
Until competition drives down costs, however, insurers insist it's more cost-effective to focus on getting women to doctors for regular Pap smears. Fully half of the 15,700 American women diagnosed with cervical cancer each year have never had a Pap smear, so they are out of reach of any technology, no matter how much better than the Pap.
"If you really want to make an impact, we need to get women in for Pap smears," said Dr. Lee Newcomer, chief medical officer for United HealthCare. The only new test United HealthCare covers is ThinPrep.
Instead of paying for most new tests, United HealthCare says this summer it will begin tracking women who haven't had a Pap smear in two years and send reminders to them and their doctors.