A new approach to breast cancer screening would put thermodynamic sensors into a woman’s bra to assess her risk.
A health tech company in Reno, Nev., is planning a Q3 launch of a clinical validation trial of a wearable sensor that it says could spot changes in breast cell metabolism that suggest a tumor is forming.
First Warning Systems proposes that its device would be cheaper and more sensitive than a mammogram, and could overcome some of the challenges of current breast screening techniques, like high rates of false positives and late detection.
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It’s been a long, steady haul for First Warning Systems, which was spun out of its parent company Lifeline Biosciences in 2008 to develop the breast health system. The company has now turned to product development firm Triple Ring Technologies to transform years of R&D work into a discrete, mobile-enabled digital device.
The vision is this: The device component of the system is a small, 16-sensor array that’s placed under a woman’s bra to collect 12 hours worth of breast cell data. The sensors pick up on thermodynamic metabolic data, which is then transmitted to the cloud, where FWS’s algorithms scour it for irregular patterns in cell behavior that indicate disturbance in circadian rhythm. (Over the last decade or so, evidence has been building that disruption in circadian rhythm is associated with increased breast cancer risk in women).
CEO Rob Royea said the core technology has been tested in more than 500 patients. “The resulting analytics produced from this device were merged into a predictive analytic engine through five years of work at Nanyang Technological University in Singapore,” he said. “We are now leveraging what we have learned from our predicate analog devices and applying our patented analytics we developed through Nanyang into our […] digital solutions.”
Feedback from the Circadian Biometric Recorder would be delivered to a physician or patient on a computer or mobile device. It’s designed for use by a physician or outpatient clinic as well as eventually for home use, Royea said.
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“Screening for breast cancer in the home will become a reality both here in the U.S. for the newly notified dense breast tissue patients and in the breast cancer epidemic regions of Asia, where massive populations are unable to, or cannot afford to, access hospital screening,” he said.
He declined to say how much a screening would cost, but noted it would be “far less than the current out-of-pocket costs for mammography.”
But first, FWS has to show the digital, algorithm-powered version of its device does what it claims it can. Royea said the company is planning to test its device in 175 women who are ordered to have a biopsy after a mammogram or other screening that returns abnormal results. The study will be led by Dr. Joshua Ellenhorn, a surgical oncologist at Cedars-Sinai Medical Center.
“Our findings will then be compared to the historic 70 percent false positive population of patients that are sent to biopsy as a result of mammography,” Royea said. “The anticipated outcome of the study should result in an increased confidence level for the physician decision process on which patients are most likely to receive positive biopsy results post mammography or ultrasound.”
If the system can show a high accuracy rate and a reduced rate of false positives, FWS would launch first in India, then spread throughout Asia beginning in January of next year, Royea said. FDA clearance and U.S. expansion would follow in late 2015.
[Image credit: FWS]
