Infrared imaging undergoes grooming as adjunct to XR mammography

NY firm sees opportunity in new technology

After four years of closely guarded development, Infrared Sciences is preparing to commercialize its BreastScan IR, a breast imaging system based on digital infrared technology. The device could be ready for market by the end of the year, if the FDA concurs.

But Infrared Sciences will not sell the product, if and when regulators sign off. Instead, the Hauppauge, NY, company wants to give it away. The recipients will be women's health centers and hospitals that promise to use the technology in conjunction with screening mammography. In return, Infrared Sciences would collect a fee for each breast exam performed with the new system.

Infrared technology is the cornerstone of the four-year-old company. Its use in women's health is neither new nor well respected. The FDA approved breast thermography in 1982 as an adjunct to x-ray mammography in screening for breast cancer. This medical application, characterized by the mapping of body heat signatures using infrared radiation, was routinely covered by Medicare and third-party payers until its efficacy was questioned by the now-defunct Office of Health Technology Assessment in early 1990 (SCAN 1/31/90). Medicare excluded thermography from coverage Dec. 21, 1992. Advances in infrared camera, computer, and software technology, however, convinced Infrared Sciences president and CEO Thomas DiCicco that thermography's fortunes could be reversed.

The company's vehicle, BreastScan IR, images the patient in an upright position. Breast compression is not necessary. An infrared map of the breast is fed into a computer, which interprets the information algorithmically, identifies potential problem areas, and provides physicians with a report.

"The problems with earlier technology involved reading variability and repeatability due to lack of equipment sensitivity." DiCicco said. "We have resolved these problems and produced an expert system that provides a quantitative, nonsubjective report to the doctor."

The first working system was developed in 2000. Several more have since been built and installed at clinical centers, including Ville Marie Oncology Research Center in Montreal; Long Island Diagnostic in East Setauket, NY; and Arena Oncology in Great Neck, NY. DiCicco hopes to have a system in place at Cornell University in the next few months. So far, more than 800 women have been imaged using the device, and more than 200 new cases of breast cancer have been identified.

The system is particularly useful when imaging women with dense breasts, according to DiCicco. Sensitivity of up to 99% has been achieved in this group.

Most intriguing is the long-term risk assessment that might be possible with BreastScan IR, he said. Infrared signs of disease may be apparent years ahead of clinical manifestations, raising the possibility that young women at risk for breast cancer might be monitored and their cancers caught long before they present a danger to health.

The key is the technology's ability to record signs of abnormal angiogenesis, according to the company. Studies have shown that the vascularization process that accompanies the growth of cancer can start 10 to 12 years before a lesion can be detected by conventional means.

While awaiting clearance from the FDA, Infrared Sciences has begun planning a marketing strategy that will underscore the system's ability to identify potential trouble areas and track changes in these areas over time. The goal will be to place systems in 10% of the more than 10,000 breast centers in the U.S. If that happens, revenues would climb into the tens of millions of dollars on a planned charge of $50 per study.

For the time being, the company is happy with clinical results that document its claims. Dr. Francis P. Arena of Arena Oncology has successfully completed more than 200 studies using the BreastScan IR. He is a strong proponent.

"I truly believe we have opened another door in the fight against breast cancer," he said. "I foresee the use of this system by a variety of physicians in conjunction with the physical exam, mammography, and sonography. It is quick, painless, uses no radiation, and can be done in even the smallest offices."