Welcome to the 21st century, where an inconspicuous device in your bra could help catch breast cancer early.
The company First Warning Systems thinks it could help resolve many of the issues with current breast cancer screening methods, by detecting tumors earlier and cutting the rate of false positives and negatives, with a new device intended to be used in conjunction with or in place of breast self-exams.
It’s developed a breast health system made up of two parts. The first is a sensor device that’s placed in a bra to measure cell temperature changes created over time by new blood vessel growth associated with developing tumors. The second is proprietary software that uses pattern recognition, chronology and artificial intelligence to look for changes in breast tissue that could indicate the presence of a tumor.
Doctors and researchers say the size of breast cancer and how far it has spread are some of the most important factors in determining the prognosis of the more than 225,000 women in the U.S. alone who are diagnosed with invasive breast cancer each year.
Recent advancements in breast imaging like 3D mammography and thermography may help in detection and diagnosis, but there are still flaws in the gold standard of mammography (which have stirred up some debate about its value as an annual screening method for women over 40).
Concerns with patient discomfort, exposure to radiation and false positives and negatives have spurred the creation of numerous other screening methods. Philadelphia startup UE Lifesciences, for example, is using sensors to develop a handheld device that would be used as an alternative to mammograms. Ascendant Diagnostics is measuring proteins in tears as biomarkers for early detection of breast cancer. Another startup, Delphinus Medical Technologies, is developing an ultrasonic breast cancer detection device.
First Warning Systems’ device, meanwhile, has been tested for sensitivity and accuracy in three clinical trials involving 650 participants, and a final clinical trial is being planned, according to recent company news. In studies, it’s shown indications of cancer up to six years before a tumor can be detected by imaging, the company says. It also requires a capital equipment investment of less than $1,000.
A phone call to the company was not returned, but recent documents posted on its website indicate that commercialization of the system will begin in Europe in early 2013, followed by a submission for FDA 510(k) clearance for a U.S. market launch in 2014, according to an executive overview of the company. It’s also in the process of raising $5 million in capital, which it will do in three rounds.
First Warning Systems was founded in 2008 in Reno, Nevada, with technology licensed from its parent company, Lifeline Biotechnologies.
[Photo from First Warning Systems]