New Bra Claims to Detect Breast Cancer

October is Breast Cancer Awareness month, and each year many groups in the United States look to educate people not only about the disease itself, but also how to detect it early.

Lifeline Biotechnologies has licensed a new bra technology called First Warning System (FWS) that it says will assist women in detecting early signs of breast cancer, and the company says the bra will be more responsive and less costly than getting a mammogram.

Lifeline says the FWS can be used either by the OB/GYN or primary care physician, and if the bras test successfully during the trial phase, they could be available for retail purchase by 2014 in the U.S.

That's assuming, of course, that the Food and Drug Administration (FDA) doesn't declare the bra a medical device and require it to undergone rigorous testing, which could slow approval by months or even years. 

Accuracy results

The trial phase for FWS began with 650 women being tested, and the company claims it gave the correct diagnosis 92.1 percent of the time.

Lifeline Biotechnologies said mammograms usually have a 70 percent accuracy reading, and noted proper diagnosis heavily relies on the knowhow of the radiologist. Diagnosis following FWS test results would also rely on the examining physician's knowledge, presumably.

"The goal of the First Warning Breast System is to enhance clinical breast examination aiding in the reduction of superfluous mammograms, needless biopsies and other screening/diagnostic procedures, as well as to develop a physiological profile of the changing breast over time to identify breast tissue abnormalities at their earliest stages," the company wrote on its website.

The company says the bra works by detecting temperature changes in the breast, which can be a sign of cancer. 

Physicians not sold

But, doctors aren't sold -- either on the idea of the bra or thermography in general. 

"A woman who chooses any breast cancer screening test based on thermography instead of mammography would be making a serious mistake that could have fatal consequences," said Dr. Ted Gansler of the American Cancer Society in an interview with Fox News. "The main reason is that once these new products are rigorously tested in clinical trials, the result of the study is that they are less effective than current practices."

However, other medical experts said they believe new methods should be added to breast cancer detection and having the FWS could potentially keep many women from being misdiagnosed. And although the FWS may not be a perfect breast cancer detector, it could be another useful test that backs up mammograms, some believe.

"Hypothetically, it's conceivable that malignant processes would have a temperature gradient compared to non-malignant tissues," said Dr. Therese Bevers of the University of Texas in a published interview. "But that gradient may not be very large."

"We see some thermograms come back as abnormal, and we do all kinds of imaging with mammogram, ultrasound and MRI and we follow the women and nothing develops, and we have women with breast cancers that are not seen on the thermograms," she said.

"Non-radiogenic"

Lifeline Biotechnologies also says because FWS is non-radiogenic it isn't toxic, and physicians could immediately start using the bra for breast cancer detection because they wouldn't require any special or additional training on how to use it. Mammograms are not toxic either, medical authorities note.

If it goes beyond the testing phase, the bra will sell for about $1,000. The company also says the FWS will be somewhat affordable for consumers if it's ever is sold over the counter, and patients could quickly and easily use the bra for testing, without it taking a lot of time from their day.