University of Virginia Clinical Research Service Evaluates Adjunctive Breast Disease Screening Device

April 1, 1997

Clinical data from the initial study of the BreastAlert Differential Temperature Sensor support its usefulness for indicating the possibility of heat-emitting, medically significant breast disease, including

Clinical data from the initial study of the BreastAlert DifferentialTemperature Sensor support its usefulness for indicating the possibilityof heat-emitting, medically significant breast disease, including cancer.The noninvasive device will be available to physicians from HumaScan Inc(Cranford, New Jersey) by mid-1997.

The clinical paper was written by medical experts with assistance fromIDEAMed, a wholly owned technology and clinical research service of theUniversity of Virginia Health Services Foundation, and has been submittedfor peer-review journal publication.

"Prior to initiating additional prospective clinical trials, wefind it informative to learn as much as possible about the performancecharacteristics of the BreastAlert Differential Temperature Sensor,"states David Martin, phd, Executive Director of IDEAMed and Assistant Professorof Radiology at the University of Virginia. "We feel that HumaScanwill gain new information which will refine and focus the scope of thefuture, multi-site clinical trials and additional technology evaluationsin early 1997."

When early-stage breast cancer is present, metabolic activity increases,producing excessive heat, which most often escapes at the surface of thebreast. The BreastAlert device records skin temperatures on three largeareas of each breast, with an average temperature differential of 2 °For more between three large mirror image segments alerting the physicianto possible underlying breast disease in need of further examination.

Device Intended to Complement Clinical Breast Examination

Based on the initial evaluations of the clinical data, Martin and colleaguesbelieve that the BreastAlert device, a 15-minute test, may provide a valuableadjunctive tool for alerting gynecologists and primary-care physiciansto the possibility of underlying breast disease. As a complement to physicalclinical breast examination, the product is designed to improve the chancesof detecting fast-growing, heat-emitting active tumors in the intervalsbetween mammographic screenings or when mammography is not indicated byscreening guidelines for women under 50 years of age.

Device May Be of Particular Value in Women Under Age 50

HumaScan president and CEO Donald Brounstein points out, "BreastAlertDifferential Temperature Sensor may be especially appropriate for youngerwomen under 50 whose denser breast tissue makes it more difficult for mammographyto pick up suspicious lesions. This product provides a 'red flag' to thephysician just before clinical breast examination, as well as to the mammographerbefore the mammogram is performed, that a specific area of the breast needsparticularly close examination."

Breast cancers tend to grow significantly faster in women under age50. According to a study published in Cancer (71:3547-3551, 1993), theaverage tumor doubling time in women under age 50 is 80 days, as comparedwith 157 days in women 50 to 70 years old and 188 days in those over age70.

"The faster a malignant tumor grows, the more heat it generates,"adds Brounstein. "For younger women, in particular, results of theBreastAlert Differential Temperature Sensor test may lead to earlier detectionand ultimately, longer life."

More than 90% of women diagnosed with early-stage cancer are alive 5years later, and yet only 58% of cancers are diagnosed at this stage, accordingto the American Cancer Society. During a clinical breast examination, aphysician must rely on palpation and eyesight to detect breast tumors,which, for women under age 50, may often occur when cancer is no longerlocalized or confined to the breast. The BreastAlert device can providean alert just before clinical breast examination and possible referralto mammography so as to enhance early detection by the physician.