Bluestar Genomics, an early cancer detection company developing and commercializing next-gen liquid biopsy tests focused on non-invasive detection of high-mortality cancers in high-risk patient populations, received accreditation for its clinical laboratory from the College of American Pathologists (CAP).
The CAP certification enables Bluestar to serve physicians and patients globally as it works towards broad commercialization of its first test for the detection of pancreatic cancer.
CAP Accreditation is an internationally recognized program that awards laboratories that meet stringent requirements of quality, accuracy, and consistency. This milestone aims to solidify Bluestar Genomics’ commitment to providing the highest standards of testing results. The company’s proprietary approach to detecting cancer early is anchored in the epigenomic process of tracking dynamic changes in cells in the body by measuring levels of the biomarker 5-hydroxymethylcytosine (5hmC) in a person’s blood.
“This accreditation—on the heels of our CLIA certification and combined with our growing body of scientific evidence supporting the utility of our 5hmC-based epigenomic testing—positions us to become the first cancer detection company to offer non-invasive epigenomic blood-based testing for early pancreatic cancer detection,” says David Mullarkey, CEO of Bluestar Genomics. “These milestones are a testament to our focus on preparing our company to serve customers around the world, helping millions of patients avoid late-stage, untreatable cancer diagnosis.”
Bluestar Genomics’ pancreatic cancer early detection test has been analytically validated and previously received FDA Breakthrough Device Designation, according to the company. It is designed to analyze a person’s changing biology and uses novel 5hmC-based epigenomic analysis to detect when cells become cancerous. The company has a prospective, large clinical validation study underway to further study its test.