Makers of a recently developed medical screening device are making claims that their “smart bra” could replace mammography as the safest, simplest screening tool for breast cancer. And what’s more, clinical trials show that it’s more accurate than a mammogram. Is this thing for real?
First Warning Systems, a Reno, NV biotechnology startup (and a division of Lifeline Biotechnologies), has been making some pretty interesting claims lately about a certain product in its pipeline: First Warning System™ (FWS), a computer-based screening device that can ostensibly detect small clusters of breast cancer cells long before they’d be evident on a mammogram – a full 6 years sooner, according to the company (Pogoreic, 2012)
The self-detection device, which looks exactly like a sports bra, is designed to be worn by a woman for 12 hours, during which time sensors in the “bra” pick up deep-tissue temperature changes. Meanwhile, pattern recognition software searches for any abnormalities in the breast tissue itself.
What do heat changes deep in your breast signify? Well, cancer cells grow quickly, and thus rely on an increased blood supply to deliver the nutrients they need. Your body very cooperatively builds new blood vessels to feed these tumors, a process called angiogenesis.
When more blood circulates to a certain area, it generates more heat in that area. First Warning claims its FWS can pick up minute variations of heat in the breast, pinpointing “hot spots” that might spell trouble.
Moreover, the company says that in three clinical trials involving 650 women, FWS scored 92.1% in sensitivity (correctly identifying cancers); 94.7% in specificity (ruling out non-cancers); and 91.1% in accuracy (overall success of the tool).
In comparison, mammograms are usually only in the 70% accuracy range. So, if FWS can continue to live up to the success of its clinical trials, it would be a much more accurate screening device than mammography.
Not only that – it would be less expensive, safer, and an easier experience for women.
The cost of a mammogram can range from $150 to $300. FWS says while the bra itself, with software, would cost the buyer about $1,000 (Pogoreic, 2012), each individual test would run only about $25.
In addition, mammograms are based on X-rays. While a woman is only exposed to a minute amount of radiation with each mammogram, it can still build up over time, putting the patient at increased risk for other cancers. FWS uses no radiation.
Finally, many of us have experienced severe pain during (and after) the mammogram itself. Despite some advances in padding, a mammogram still involves a very tight squeeze to a very sensitive part of the body. FWS’ manufacturers say their device is no more uncomfortable than wearing a sports bra.
So, can you expect to see your own FWS bra replacing the mammogram machine at your local hospital anytime soon?
The company says it plans to roll FWS out in Europe next year. Meanwhile, it’s running a final clinical trial here in the U.S., and if all goes as planned, FWS may be available to all of us here in America sometime in 2014.
That is, so long as you can afford the $1,000 initial investment, and $25 for test results each time you wear the bra.
As I wondered at the start – is this thing for real?
Training in the interface between medicine and media has made me a skeptic. Since FWS is apparently going through the right steps (clinical trials, FDA approval), I can’t dismiss this out of hand as some kind of marketing smoke and mirrors.
But for a very small company to have come up with a medical device that could potentially turn the universe of breast cancer screening on its ear... well, I just wonder why more people – more companies, government health agencies, other businesses – aren’t talking about it.
Time will tell.
Want to know more? Watch the company’s video.
Pogoreic, D. (2012, October 03). This “smart bra” uses sensors and predictive analytics to aid in early breast cancer detection. Retrieved from http://medcitynews.com/2012/10/this-smart-bra-uses-sensors-and-predictive-analytics-to-aid-in-early-breast-cancer-detection/
Castillo, M. (2012, October 15). Bra aims to detect breast cancer before mammogram. Retrieved from http://www.cbsnews.com/8301-204_162-57532759/bra-aims-to-detect-breast-cancer-before mammogram/?utm_source=feedburner&utm_medium=feed&utm_campaign=Feed: CBSNewsGamecore (GameCore: CBSnews.com)
Published On: October 16, 2012