Biofield’s cancer diagnostic system takes aim at imaging modalities

Company sees market potential of up to $1 billion

A non-imaging-based cancer diagnostic procedure could offer tough competition for alternative imaging modalities in the U.S., either later this year or in 1998. Supplier Biofield submitted an application in December to the Food and Drug Administration for premarket approval (PMA) of its Alexa 1000 system in breast cancer diagnostic applications.

Potential future applications of the system include breast cancer screening and diagnosis of prostate, ovarian, colon, and skin cancer, according to Kenneth Anstey, Biofield president and CEO.

"There are very compelling reasons why this test will be used not only by gynecologists but radiologists," Anstey said. "(We are) adding clinical value beyond existing modalities. The existing process (in breast cancer detection) is just not working. We believe that Biofield has a solution not only for detecting more cancers but to prevent more tests and more biopsies (from being performed) on benign lesions."

Executives from Biofield discussed technology and business strategies at the Hambrecht & Quist Healthcare Conference in San Francisco last month. The company is headquartered in Roswell, GA, outside Atlanta.

Alexa 1000 is based on proprietary electrical sensing technology used to indicate the proliferation of cancer cells through the measurement and analysis of skin surface electropotential differentials, said Mark Faupel, vice president and director of science. Faupel is also inventor of the technology and a co-founder of Biofield.

"The test is relatively straightforward in use. It is an in-office procedure superficially as simple as an electrocardiogram," Faupel said.

While Biofield has been in existence for close to a decade, Alexa will be the firm's first product to reach market. Sales should begin in Europe, where multisite clinical results were available prior to Biofield going public last March.

"We expect to launch the product in Europe shortly," Anstey said. "Our intentions are to do that with a partner in Europe. We are currently in negotiations with several."

Biofield expects to be ready to launch Alexa by the end of this year in the U.S., in anticipation of FDA certification around that time, Anstey said. The PMA submission has been granted expedited review by the FDA (SCAN 1/8/97).

Concurrently, the company is preparing its reimbursement dossier to support the case for procedural payments both in the U.S. and Europe, he said. Clinical testing has also been undertaken in Japan.

Noninvasive analysis. Alexa 1000 is completely noninvasive, Faupel said. It reads electrical signals generated by the body itself, analyzes these measurements, and then displays quantitative data. A preprogrammed algorithm produces the results of the test on a scale of one to 30. The higher the number, the more likely the patient is to have a malignant lesion.

Key to this analysis is the fact that proliferating cancer cells send out different signals than do healthy cells reproducing at a normal rate.

When cells divide, they depolarize electrically, Faupel said. As cancer develops in a breast duct, the electrical gradient is different on the outside compared with the inside of the duct. In contrast, a normal breast or a breast with a benign lesion has a relatively homogeneous gradient.

"The voltage differential measured on normal breasts with homogeneous cell division rates is relatively small," he said.

Results of Alexa clinical trials indicate that this test has high sensitivity in detecting cancer and can catch it early, Faupel said. It also performs well in showing when patients are negative, or cancer-free. The recent FDA submittal was based on a U.S. multicenter study of over 1000 patients enrolled in six clinical sites.

"We obtained a high sensitivity: approximately 95% overall and higher in clinically difficult subgroups," Faupel said. "We also obtained a high negative predictive value of approximately 94% overall and again higher in certain clinically difficult subgroups."

These subgroups included patients under 45 with relatively dense breasts, patients with small breasts, and patients with small palpable lesions. Sensitivity in these normally difficult cases ranged from 96% to 97%, he said.

Competing breast cancer diagnostic modalities include mammography, ultrasound, fine-needle aspiration, and core-needle biopsy, Anstey said. Once the determination of cancer is made, patients are then sent on for further evaluation, either with open biopsy or surgery.

Eight million women annually are diagnosed with breast cancer in the U.S., according to Anstey. Of these, 200,000 have cancers that are not detected. In addition, of the 700,000 breast cancer patients sent on for biopsies, only 20% turn out to have cancerous lesions.

"Too many cancers are being missed today using the existing modalities and too many tests are being conducted on benign lesions," Anstey said.

The large number of false positives in conventional mammography was an issue in last month's decision by the National Institutes of Health not to recommend screening mammography for women aged 40 to 49 (see story, page 1).

Most of the revenue stream from Alexa will come through purchases of its single-use sensors. The capital cost of the system should be only around $25,000, Anstey said.

If Alexa is certified for use on the eight million U.S. women going through diagnostic analysis each year, and the sensors are priced in the range of $75 to $125, the U.S. market potential for this application of the technology would range from $600 million to $1 billion annually, Anstey said.

On the consumer side, the technology stands to benefit patients, physicians, and payors through improved detection, ease of use, and cost reductions, he said. Cost savings may be achieved both by reducing unnecessary tests and by having the test performed by nonspecialists in an outpatient setting.