Cyrcadia Health (Cyrcadia) is a US based medical device and software company which utilizes biosensors and predictive analytics to accomplish breast cancer detection through personalized wearable devices. Cyrcadia is conducting clinical tests of its patented wearable technology for the detection of breast cancer using dynamic circadian rythm tissue monitoring and predictive analytic analysis. With over 200 previous patient cases completed, and eight years of advanced machine learning algorithmic analysis accomplished, Cyrcadia continues clinical validation studies with its patented technology at El Camino Hospital in Mt. View, CA and The Ohio State University. The targeted outcome of the 173 patient trial was to demonstrate Cyrcadia’s advantage as an adjunctive screening solution in reducing today’s current 70% plus of breast biopsies that are conducted through mammography recommendation on noncancerous tissue. A secondary, but equally important outcome of the trial is to show Cyrcadia’s tissue agnostic capabilities, proving it superior in detecting abnormalities in patients with dense breast tissue (over 40% of women worldwide) over the current goal standards of mammography, and ABUS Ultrasound for this population.
Through a 2 to 12-hour wear time, the Cyrcadia sensor filled breast patches track temperature changes in variance over time, believed to be a circadian cellular change caused by a reduced PER1 and PER2 protein expression in the presence of breast cancer. When tissue is healthy, the Cyrcadia predictive algorithmic output displays an irregular variant metabolic pattern. In the case of cancer, the varied pattern of metabolic activity becomes compressed, or demonstrates more of a flatline profile in tissue infused cancers. This outcome, though monitored by Cyrcadia’s engineering team, results in an automated yes, no result.
THE TECHNICAL CHALLENGE:
BREAST TISSUE DENSITY – Multiple recent clinical studies have determined that breast tissue density has been identified as a limitation for screening mammography, the “gold standard” diagnostic tools for breast cancer screening used today. Legislation in 32 US States, and Federal legislation pending, now requires physicians to notify patients of their density condition, and if having dense tissue, mammography results are less accurate with their condition in addition to having a higher propensity for cancer.
- Mammography false negative results increase dramatically with patient tissue density, from 20% false negatives for all tissue types, and up to 50%+ false negative results with the densest of tissue types.
- The Cyrcadia Health solution is tissue agnostic in detecting early circadian cellular changes indicative of cancer, and does not rely on specular reflective capabilities of varying tissue densities, such as is necessary with ultrasound or mammography, to make our diagnosis.
- Cyrcadia Health’s historic false negative result of 17.3% shows diagnostic accuracy improvements for all tissue types, but most critically in the dense patient population.
- 40% of the population have a dense breast condition, a higher propensity for cancer and mammography accuracy is challenged with this condition. The Cyrcadia Health’s solution is targeted at this higher risk population.
Proactive Personal Breast Health – Your Choice
Cyrcadia Health has multiple issued patents for its exclusive hardware and software innovation in the area of circadian biometric recording for cancer detection. The Cyrcadia Health technology uses a smart conformable patches which when placed under a sport bra or normal garment collects 2 to 12 hours of normal and abnormal cellular activity associated with breast cancer. Circadian rhythm-based temperature variances of cell cycles are measured to identify abnormalities at the earliest stages of abnormal cellular growth and proliferation. Exclusively patented predictive analytic processes report abnormal cellular change to the woman and the physician remotely and automatically. The Cyrcadia Health patient results can be utilized to supplement decision process on normal, dense tissue and surgical biopsy decision processes.
The Cyrcadia Health solution contains wearable, conformable intelligent breast patches which communicate your personal data through your PC, and ultimately, your smart device, enabling communication into a big-data, predictive analytic software core laboratory.
Through the detection of a mosaic of thermal time based changes over the body’s normal circadian cellular regeneration, Cyrcadia Health’s technology detects normal circadian cellular baselines, as well as those abnormal patterns associated with the state of cancer. Based on pathology outcomes, earlier patient study results indicate that Cyrcadia Health’s accuracy can exceed 80% and consistently offers improved results over traditional testing methods with patients, who have dense breast tissue. Cyrcadia Health’s technology does not rely on tissue or calcification image response as is identified through mammography or ultrasound. Cyrcadia Health’s historical indications suggest earlier predictive potential of circadian alterations at the cellular level, a key focus for upcoming clinical validation trials. Partially funded through the Canary Foundation, the longest standing foundation dedicated to early cancer detection, Cyrcadia is setting out to determine if it is detecting circadian cellular changes associated with the reduction of PER1 and PER2 protein exhibition in the presence of familial and sporadic cancer over the entire breast structure, as well as localized thermal activity associated with cancer cell generation and infiltration in normal tissue.
Cyrcadia is addressing the Health and Human Services Affordable Care Act targeted Precision Medicine Initiative. Through personalized healthcare monitoring, Cyrcadia is intended to detect the earliest potential progression of the cancerous disease state. Instead of only correlating to late stage imaging outcomes with clinic or hospital based mammography, Cyrcadia is partnering with the Canary Foundation, who has also supported the current trials financially, to correlate their findings with early biomarkers already identified by Canary as indications of early cancer cell development. Although screening and detection of breast cancer has improved dramatically over the last decade in westernized cultures, the mortality globally has not improved. Clearly we are getting to the state of breast cancer far too late to have an impact. Cyrcadia’s target is through Precision Medicine, personalized healthcare, to catch the incidence of cancer cell development early in the woman’s own environment. Correlating these results directly with early biomarker activity for this clinical patient population could enable much earlier therapy of the patient’s cancerous condition.
Due to its focus on precision medical initiatives, Cyrcadia has been requested by The Stanford Medicine X program to participate in a randomized trial to demonstrate the increased value of personalized healthcare assessment, versus hospital-based treatment in a randomized population. That trial request has been expanded now with and through Stanford University to key institutions in Asia including Japan, South Korea, India, and Australia, where mass populations of women either cannot access healthcare, or social, economic, or religious morays keep them from exposing themselves in the presence of a physician. For women in many of these countries, discovery comes far too late, and treatment is ineffective.
The Cyrcadia Health solution is a cost effective system that through early and routine monitoring is dedicated to improving patient outcomes, reducing e-healthcare costs, providing more breast health information and data, and is patient-friendly solution for breast health monitoring.
Reno, NV 89502