I had a chance to chat with Rob Royea, the CEO of First Warning Systems (FWS – soon to be renamed Cyrcadia Health) about their novel approach to breast cancer screening—one that has no compression and no X-rays (yeah!). And it is useful in the subset of women where mammography is either not indicated or not as useful (e.g., young women with dense breast tissue). MRI has been used in this group, however, it has less specificity and is far more costly.
The company has developed a complex sensing grid that can sense temperature changes in throughout the tissues of both breasts. The raw data from the sensors (collected over 12 hours) is then fed into a cloud-based big-data analytic processor that allows detection thermal fingerprints that are highly correlated with breast cancer. Unlike prior attempts to use thermography, Cyrcadia’s technology is able to detect abnormal circadian changes in heat production that are characteristic of breast cancer. The analytic processor is comprised of proprietary self-learning predictive analytic algorithms that are “self-learning”—that is, they can learn from each new case and thus refine outcomes. Cyrcadia has been issued three patents on the process and technology and have multiple patents pending. If you want more technical details about the science behind their approach, you can find multiple papers/chapters on their website: http://cyrcadiahealth.com/publications/. Because the device is not toxic, is comfortable, and relatively inexpensive (it will be leased from the company), it can be used regularly (e.g., monthly) as a safe and effective screening tool. According to the FWS website, the device was designed to be used at the point of entry of women into the medical care system (e.g., clinics, PCP offices, Ob/Gyn offices). It can also be used for home based monthly breast screening.
An associated mobile app will allow social sharing so family members at risk can be encouraged to do monthly screenings with the device. For example, if you have a family history of breast cancer and you are worried about your daughter in college across the country, you will be able to check in and nudge her if she is not using her device monthly as she should. Users will also be able to enable automated communication to their physicians so they can be notified of a positive finding.
How can I get one?
The company is planning on releasing the technology in a suite of products. Clinic models will be inserts that can be worn under your normal clothing. They are also working with Flextronics, to develop a “Cyrcadia Health Inside” version that can be embedded into sporty-type bras manufactured by independent garment manufacturers. There will also be a pharmacy-based model that is marketed to the wellness market. An earlier version of the device already has an FDA 510 clearance. Royea tells me that initial studies of 500 women have shown a 90% correlation to the actual state of cancer in the women’s breasts. The company will be conducting further clinical trials this fall. If all goes well, the device will be available outside the U.S. by mid-2015. As you can imagine, the development and testing of this sophisticated technology have been costly. According to Royea, the company has raised $2.1 million in seed funds and has another $500K promised this month. They enter their Series A raise of $5M in September. With global incidence of breast cancer being 1 in 8 women, the potential of this company to do well is huge and the potential to do good (while doing well) is limitless. Please watch the video interview to hear Rob Royea talk about this potentially disruptive way to screen for early breast cancer.