This is a guest post by Irma Rastegayeva, an innovation catalyst, entrepreneur, and consultant based in Boston. She left a successful 5-year tenure at Google in 2016 to pursue her passion for medical technology and healthcare innovation.
Every 19 seconds, someone in the world is diagnosed with breast cancer “This changes everything!” said women’s health nurse practitioner Barbara Dehn. And we desperately need a game-changer. 1 in 8 women in the US will develop invasive breast cancer. Every 13 minutes, one woman dies of breast cancer in the US. Every 19 seconds, someone in the world is diagnosed with breast cancer. The good news is that breast cancer survival is strongly influenced by early and accurate detection: 99% survival with early diagnosis vs only 27% with late diagnosis. We can move the needle on breast cancer by improving early diagnostic capabilities. Here is a story about a man on a mission to combine the power of Internet of Things, temperature sensing wearable technology, and Artificial Intelligence to disrupt the early breast cancer detection.
Capturing the journey
On April 27, I attended the world premiere of DETECTED at the Independent Film Festival Boston 2017. Detected is a documentary about an intelligent bra (iTBra), a wearable device engineered to detect breast cancer. Seth Kramer, Daniel A. Miller, and Jeremy Newberger directed the film and Melanie Griffith, an actress and breast cancer survivor, narrates it. The movie is a collaboration between Ironbound Films, Cisco, and Cyrcadia Health, each making a unique contribution to the film.
The 16-minute movie unfolds like a thriller, giving us a rare window into a journey of a medical startup on a mission to save lives. We go on a multi-year wild ride with the Cyrcadia Health CEO Rob Royea as he takes on a monumental task: turning a breakthrough innovation into the medical-grade wearable device making the early, non-invasive breast cancer detection possible on a mass-scale. DETECTED makes us rethink what we know and start asking questions. What if technology existed to significantly improve early breast cancer detection, drastically reduce the number of unnecessary biopsies, while increasing access to screening, improving clinical outcomes, and reducing costs? What if these “far out” goals were indeed achievable?
Why we should care
Mammography is the current gold standard diagnostic tool for breast cancer screening. But screening mammography has an important limitation: its results are significantly less accurate in women with dense breast tissue. Breast tissue density is a recognized medical condition which affects more than 40% of women worldwide. Dense breast tissue is comprised of less fat and more connective/fibrous and glandular tissue, and ranges in severity from Level A (fatty) to Level D (extremely dense). As the density of a breast increases, the ability of the mammogram to reveal cancer decreases. Because both dense breast tissue and breast cancer appear white on mammography images, finding cancer in these dense tissue breasts is akin to looking for a distinct snowflake in a snowstorm. In fact, having dense breasts is the strongest predictor of mammography missing cancer. It is undeniable that early screening and detection are key to improved treatment outcomes. As of this writing, 38 US states have laws on the books requiring doctors to notify patients that their breast density is a significant risk factor for cancer and mammography is less accurate for them. A Federal law is also under consideration. The cancer risk in women with extremely dense breasts is up to 6 times higher compared to normal/fatty tissue, and shows a much more rapid acceleration of the condition. Still, 70% of breast biopsies that are conducted as a result of suspicious findings on a mammogram are performed on non-cancerous tissue. The staggering numbers of such unnecessary biopsies could be reduced with improved diagnostic screening in women with dense breast tissue.
How the iTBra works
99% survival with early diagnosis vs only 27% with late diagnosisCyrcadia Health is on a mission to solve these problems with their early breast cancer detection solution, at the intersection of personalized medicine, wearable devices, sensor technology, and predictive analytics. The iTBra is comprised of two wearable breast sensor patches; flexible and intelligent, they detect dynamic circadian temperature changes within breast tissue. The collected data is anonymized and securely transmitted to the Cyrcadia Health core lab for analysis. The machine learning predictive analytic software was developed in conjunction with the Nanyang Technological University of Singapore. It uses a series of algorithms and Artificial Intelligence to identify normal breast circadian cellular regeneration baselines, and to detect and categorize abnormal patterns in breast cellular behavior, which are associated with the state of cancer. In contrast with mammography and ultrasound, which rely on specular reflective capabilities of varying tissue densities, the Cyrcadia Health solution is tissue agnostic and is able to detect early circadian cellular changes in all tissue types and varied age groups. The abnormalities in the circadian rhythm-based temperature variances of cell cycles are present at the earliest stages of abnormal cellular growth and proliferation, and serve as the early indicators of breast cancer. Exclusively patented predictive analytics technology identifies these abnormal cellular changes and reports results to the health care provider, used to assist in their clinical decision process.
What’s next for this product
Detected captures Rob Royea’s full-hearted determination to finalize the design of the wearable sensors, secure the funding, establish partnerships, and lay the groundwork for clinical studies. We see Rob as he advances the cause, gains support, and faces setbacks. The film ends with a cliffhanger: several women telling their stories and expressing hopes for this technology as they enroll in a clinical trial. We wonder: what happens next? Fortunately, the world premiere at the Somerville Theater was followed by the live Q&A session with Rob and 2 of the movie’s directors. To the delight of the captivated audience, Rob shared the results of the successfully completed clinical trial. The first prototype of iTBra (featured in the film) took 48 hours to complete the scan. The current version of the device completes the scan in only 2 hours with more than 80% accuracy.
According to Rob Royea, the iTBra is currently in production with the go-to-market target of end of 2017. Cyrcadia partnered with the leading producer of wearable devices to build the heat-detecting technology. The device will launch first in Asia, where the 10-year earlier onset of breast cancer and significantly lower availability of breast cancer screening compared to the US create perfect conditions for the initial launch. To facilitate and oversee the launch, Rob and his family will move to Asia. That’s true grit and dedication.
The movie, which turned out to be a 2-year project, was made possible partially by Cisco’s support and vision. A global leader in Cloud, IoT, and Security, Cisco recognized the incredible potential of IoT and connected devices to aid in saving lives, and wanted to help tell this story. When Seth Kramer first approached Cisco leadership with the proposal to document this journey, the iTBra’s technology and form factor were still nascent and there was no guarantee of the project’s success. “We fundamentally did not know if this will work, on real women, in a controlled study” said Rob Royea reflecting to the start of the DETECTED project. The risk undertaken by Cisco and Ironbound Films paid off, because “now we know this technology does work!” With more than 40% of women worldwide having dense breast tissue, availability of this personalized, intelligent, and connected technology is bound to be a game-changer in early breast cancer detection, and therefore in cancer treatment outcomes.
Where you can see the movie
Cisco will host a special screening of DETECTED in Los Angeles on June 5, 2017. The team is also working to make the movie widely available online, stay tuned for the updates!
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