Circadian Thermal Sensing to Detect Breast Disease

The Cyrcadia CBR™ (Circadian Biometric Recorder) includes wearable biometric patches and

a detachable data recording device. The CBR™ records chronobiologic data while the

patient is totally ambulatory and going about her normal daily routine. Following removal

of the detachable data recording device from the wearable biometric patches, the data is

transferred to a computer for analysis. The Cyrcadia CBR™ will be placed on the patient

for the duration of 2 to 24 hours. There is no restriction of daily activity. The study

subject is requested to sponge bathe rather than shower while wearing the device, keeping

the device dry during the testing procedure. After this period, the CBR™ will be removed

and the data will be transferred to a computer for analysis.

The primary endpoint of this 173 patient study is to determine the accuracy of Cyrcadia

CBR™ as a supplemental screening device to mammography and ultrasound in predicting a

diagnosis of breast cancer. Specific emphasis will be on the utilization of the CBR as a

secondary screening device to reduce the number of biopsies currently performed on

non-cancerous tissue. A secondary emphasis will be on the CBR to act as an improved

screening solution over mammography specifically in those patients with dense breast

parenchymal tissue.

Other endpoints of the study are:

- to determine the accuracy of Cyrcadia CBR™, including the positive predictive value,

negative predictive value, false negative rate and false positive rate.

- to determine the optimal wear time for the Cyrcadia CBR™.

- to demonstrate substantial equivalent or improved results when applied to Cyrcadia

original patient case study with identical advanced neural network analysis

computational results.

Study subjects will be followed at 6, 12, 18, and 24 months to update their clinical

status.