Focus : Health Care Cancer has a new foe BY JOHN GOLDEN

Focus : Health Care
Cancer has a new foe
BY JOHN GOLDEN

Richard Metz, Polymedco Inc. marketing director, demonstrates the company's automated fecal occult blood analyzer.

The medical-lab technology is nearly two decades old and used widely in Japan and Europe, but only within the last three years did the U.S. market open to a cancer-screening device and method that could significantly lower both deaths from colorectal cancer and health-care costs.

A Cortlandt Manor company, Polymedco Inc., is trying to sell medical department heads and hospital CEOs on the economic and disease-management benefits of an automated fecal occult blood test system for which it is the exclusive marketer in the U.S.

Polymedco president Drew Cervasio, a former salesman who co-founded the 125-employee company in 1980, said the fecal occult blood test (FOBT) product “is the most interesting project we’ve ever been involved with.” Company executives describe it as an accurate and economically efficient early detection weapon in the fight against the second-leading cause of cancer-related deaths in the country.

A national supplier of a variety of clinical diagnostic products that employs 85 workers at its corporate office in the Northern Westchester Business Park on Furnace Dock Road, Polymedco nationally launched its automated fecal occult blood analyzer, the OC-Auto Micro 80, in 2005 after six months of testing and modifications to gain U.S. Food and Drug Administration approval. The product was developed by one of the company’s manufacturing partners in Japan, where it was introduced in 1988, said Frank Coviello, director of new product development at Polymedco.

The automated system is used in Japan’s national cancer screening program, he said. More than 40 million tests have been performed on the instrument internationally. Italy also uses it in its national cancer-screening program.

The innovative system uses an immunoassay-based method to detect human hemoglobin in fecal specimens. Though the immunoassay method has been used in manual testing in place of the older and more widely used Guaiac FOBT method, “The automation is unique to Polymedco in this country,” Coviello said.

“The test was not very good,” Coviello said of the Guaiac method, the results of which could be skewed by a patient’s diet. “It missed a lot of cases of colorectal cancer, plus it gave a lot of false positive results.” Those false results sent patients to unnecessary and costly colonoscopies.

The conventional fecal occult blood test requires the patient to collect three stool samples over three days. According to studies, “Only about one in five people will comply with performing that test,” Coviello said.

That reluctance on the part of patients shows in the relatively low percentage of at-risk adults, 39 percent, that receive colorectal cancer screenings. According to The State of Health Care Quality 2006 report by the National Committee on Quality Assurance, an estimated 5,700 to 11,900 deaths in the U.S. in 2005 and $267 million to $374 million in hospital costs could have been avoided by colorectal cancer screenings.

The Polymedco FOBT requires only one stool specimen that is more easily and more hygienically gathered with a collection kit. “More people will end up participating in the screening process,” Coviello said. “After all, isn’t the best screening test the one that gets performed?”

The automated fecal occult blood analyzer, which can process up to 10 samples in eight minutes, improvers laboratory work flow and eliminates the “subjectivity” of manual immunoassay-based testing, in which tests are visually interpreted, with standardized readings, Polymedco executives said.

The lab machine can link electronically with hospitals’ or physicians’ patient-management records systems. “The entire medical process can be enhanced,” Coviello said.

Since introducing the FOBT system two and half years ago, Polymedco has signed up more than 100 customers nationwide. “We have a diverse user base” of physician groups, hospitals, specialty clinics and health maintenance organizations, said Richard Metz, the company’s marketing director. They include the Mount Kisco Medical Group in northern Westchester and Putnam counties; North Shore-Long Island Jewish Hospital and its 13-hospital chain; the Scripps Research Institute in LaJolla, Calif.; Lahey Clinic in Massachusetts and Kaiser Permanente, the nation’s largest HMO.

Users are “extremely enthusiastic” about the product, Metz said. “They’re thrilled about the increased patient compliance and ease of use of the instrument itself, the results they’re getting.” For users, he said, “the common denominator” is an increase in earlystage cancer detections since implementing the automated system.

“To me, the most significant feature of this product is the ability to detect early cancer,” Coviello said.

Cervasio, the company president, said a West Coast institution has increased patient compliance in its colorectal cancer screenings by 75 percent and detected more than two-dozen cancers since switching to the automated test. “Those patients wouldn’t have been detected,” he said. “Those are pretty dramatic results.”

Yet selling the nation’s health-care professionals on technological innovation in diagnostic testing is not an easy task. It is difficult to gain access to the chief physicians and CEOs whose medical departments and hospitals stand to benefit in cost savings and more effective health care, Cervasio noted.

In the U.S, “We’re very slow to respond to change in the system,” he said. “Our biggest challenge is educating the medical community regarding the change in the standard of care what we do.”

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