ClearNote Health

ClearNote Health (formerly Bluestar Genomics) has developed a proprietary non-invasive blood-based epigenomic test for early detection of pancreatic cancer. The company received FDA Breakthrough Device designation for its pancreatic cancer screening test targeting high-risk populations such as those with new-onset diabetes. Large-scale clinical validation studies are ongoing, and the product has entered commercial distribution both in the U.S. and internationally. The technology leverages machine learning to analyze changes in the epigenome—specifically levels of 5-hydroxymethylcytosine—to identify early-stage cancers before symptoms appear. Initial results have been published validating this approach's accuracy.