It should prove especially useful for women with dense breast tissue who are severely limited at present when it comes to diagnostic tools.
Mammography and ultrasound are virtually useless for dense breasts, though few women know whether they have dense tissue and so aren’t aware of their higher risk level.
First Warning Systems Inc., the Reno, Nev., manufacturer of the “smart bra,” says it uses 16 temperature sensors to detect “deep-tissue temperature changes” from the growth of new blood vessels related to cancer cells over 12 hours.
The First Warning Systems method would require a woman simply to wear the smart bra for 12 hours at home or at work rather than over the full 24-hour circadian cycle, because the software can model the last 12 hours.
That technology promises to provide noninvasive screening that’s earlier and more accurate than the mammogram X-rays that represent the current standard for breast cancer detection.
First Warning Systems said it has created specialized computer software that can “remember and recognize” the patterns of known cancer cases.
That allows the software to provide human physicians with the probabilities for the presence of cancer based on previous patterns.
“The computer, ultimately, has an advantage because it has a perfect memory, and additional data can be integrated into the analysis such as age, family history, age at first birth, in ways that the radiologists cannot,” FWS explained.
In three clinical trials involving 650 women, the First Warning Systems screening method beat mammograms head-to-head with 90 percent accuracy, and with false readings of less than 10 percent, according to the company.
A promotional video suggests the company’s method also can detect signs of cancer just three or four years after the first gene mutations; mammograms can detect tumors no sooner than about 10 years after the first mutations.
The method even offers the possibility of cheaply and effectively monitoring a breast cancer patient’s health during radiation or chemotherapy treatments.
Such results sound promising if they can be verified. First Warning Systems has not released the full clinical trial results yet.
The company said it plans to make all its clinical trial studies and results available to the public after completing a fourth and final clinical trial in2013 and clearing the trial results with the U.S. Food and Drug Administration.
“Cancer-detecting bra heading to FDA for approval.” By Jessica Chasmar, The Washington Times. 14 February 2013.
“Facing Cancer, a Stark Choice.” By Tara Parker-Pope, The New York Times: Health & Science, 21 January 2013.
“False-Positive Mammograms Can Trigger Long-Term Distress.” By Kathleen Doheny HealthDay Reporter, U.S. News Health.