Scantek licenses breast disease device

Scantek Medical has found a Latin American distributor for a novel device that claims to detect early signs of breast disease by measuring differences in skin temperature between breast tissue. The Denville, NJ, company has licensed South American rights to its Breast Abnormality Indicator (BAI) to Sandell, a medical products distributor based in Montevideo, Uruguay.

BAI uses heat-sensitive pads that are placed on each breast to measure skin temperature, which may be higher in cancerous tissue due to its higher metabolic activity, according to Scantek. A temperature difference of 2F between mirror-image segments of the breasts indicates that a pathological condition may be present and that a patient should be sent on for mammography screening.

BAI is designed to be used as an adjunct to conventional mammography rather than as a replacement, according to the company. For example, it could be used to determine whether a woman under the age of 40 who might not normally receive regular mammography should be scheduled for a mammogram.

The Sandell agreement will complement a deal Scantek has with HumaScan of Cranford, NJ, which received marketing rights to BAI for the U.S. and Canada. HumaScan will sell the device as BreastAlert Differential Temperature Sensor (DTS) and plans to begin marketing the product in December. HumaScan has resolved issues that earlier this year forced the company to postpone the product's launch (SCAN 7/9/97). BAI has received 510(k) clearance from the Food and Drug Administration.

Scantek hopes to begin European sales of BAI early next year, and is lining up distribution partners for the product in that region, according to the company.