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Biomed Firms Race to Improve Pap Smear Tests


Despite a crackdown on medical costs, few people think that patients or insurance companies will object to a slight rise in price for new products if those products yield better Pap smear results.

"For the first time (doctors) are willing to pay more to get an accurate Pap smear. In the past, the cheapest was the best," said Rosenthal. "Now there is a realization that Pap smears are important. They are not dipstick tests."

To many in the industry, automation appears to be the only solution to personnel shortages and the public clamor for accuracy.

Two tiny technology companies have emerged as the leading candidates in the drive to automate Pap smear diagnosis, and each is racing to finish first.

Papnet, manufactured by Neuromedical Systems Inc. in Suffern, N.Y., is expected to be the first computerized system to be installed in labs, starting this summer. Using image processing technology pioneered by Jet Propulsion Lab in Pasadena, Papnet picks the 64 worst-looking cells out of the hundreds of thousands that appear on a typical Pap smear slide.

Those suspicious cells are shown on a TV screen, which the cytotechnologist examines to make a diagnosis. Papnet eliminates eye strain and fatigue that result from trying to find the two or three abnormal cases out of every 100.

"It's a needle in a haystack problem," said Mark Rutenberg, co-inventor of Papnet. "Right now, the cytotechnologist has to find as few as 10 bad cells out of 300,000. The job with our machine is to find those 10 cells out of 64."

Neuromedical has notified the U.S. Food and Drug Administration of its intention to sell Papnet for research purposes. This is a step towards being able to introduce the machine commercially.

Pharmaceutical giant SmithKline Beecham has announced that it will install Papnet in two of its labs this summer. And UCLA Medical Center has said it intends to get one within the next eight weeks.

Neuromedical claims that during in-house tests, Papnet has never failed to identify a Pap smear containing cancerous cells. However, academic studies to confirm the machine's effectiveness are years away.

Dr. Leopold Koss, one of the world's foremost experts on Pap smears and chairman of the pathology department at Albert Einstein College of Medicine in the Bronx, has just begun reviewing Papnet's performance. "I wouldn't be wasting my time if the instrument were not promising," he said. I and my colleagues consider the machine very interesting."

Neuromedical, which plans to make a $20-million to $30-million public stock offering in a few months, expects to rent the machines commercially for $5 per Pap smear.

"On a slow day, we get calls from 30 labs wanting the machine," said Rutenberg.

Rosenthal at UCLA confirms that laboratories are anxious to find an automated system that works. "People who have seen this and other machines have practically signed contracts," she said. "They say, even before (the machines) are ready, 'We'll take five.' "

Neuromedical's chief competi tor is NeoPath Inc. The privately-held Bellevue, Wash., company is developing an image-processing system--the AutoPap 300--that will automatically sort slides into two piles: normal and suspicious. The cost is projected to be under $1 per slide. The company expects to begin FDA trials by year-end.

Financial analysts say whichever company first succeeds in automating Pap smear diagnoses stands to strike it rich.

"There are no (automated) systems out there today," said Wayne Wager, a general partner with the venture capital firm Cable & Howse. "The market is somewhere in the neighborhood of half a billion dollars in equipment for processing Pap smears."

Until now, the Pap smear has successfully resisted automation because of the complexity of the cells on each slide. They come in various shapes and sizes and often overlap like pancakes. Humans can distinguish boundaries, but computers often can't.

"Our eyes are more clever than the machine--so far," said Karen Andersen, president-elect of the California Assn. of Cytotechnologists.

Besides automation, biomedical companies are working on tests to detect a virus--human papilloma virus (HPV)--that some scientists think may be a precursor to cervical cancer. The tests are being used by researchers in conjunction with the Pap smear.

Life Technologies in Gaithersburg, Md., a publicly held company traded over the counter, is the only company to date that has received approval from the FDA to sell such a test for diagnostic purposes.

The company has sold about $4 million worth of its ViraPap product since the test was introduced last year.

Enzo Biochem in New York and Digene Diagnostics in Silver Spring, Md., are developing tests that they say are faster and easier to use than the ViraPap.

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