Developer of the wearable device for breast cancer early detection Cyrcadia is entering into a clinical trial and is enrolling the first clinical trial participants at El Camino Hospital in Mountain View, California. Utilizing its previous FDA cleared device as a predicate, Cyrcadia Health (a division of Cyrcadia) is combining the company’s fourth generation, wearable device technology, made by Flextronics, and the SalesForce database software, to track the clinical results.
“We are targeting both the 70% of the population that undergo biopsies on non-cancerous tissue resulting from mammographic referral, as well as mass screening of patients with dense breasts,” said Rob Royea, president of Cyrcadia Health. “Patients with dense breast tissue have a higher propensity for cancer. Furthermore, mammography is challenged by detecting cancer in dense breast tissue as it can mask cancer cells and lesions.”
After the trial is completed, Cyrcadia plans to produce a wearable, smartphone enabled technology, called the iTBra, which will utilize a comfortable data collection device placed under a bra to collect from two to twelve hours of breast cell data (dynamic cell chaos). Circadian rhythm-based temperature variances of cell cycles are then measured through a patented process to identify abnormalities at the earliest stages of cellular change, the results of which are transferred through a smart device to a global cancer library, where advanced analytical analysis occurs, and results are communicated back to the patient and physician.
Cyrcadia Health’s study is expected to enroll approximately 250 at three sites across the U.S.
One in eight women in the U.S. alone are diagnosed with breast cancer annually and approximately 39,000 die from the disease each year, many due to lack of early detection.