Bluestar Genomics, Inc., an early cancer detection company leading the development and commercialization of next-generation liquid biopsy tests initially focused on non-invasive detection of high-mortality cancers in high-risk patient populations through a standard blood draw, today announced it has received Clinical Laboratory Improvement Amendments (CLIA) certification from the U.S. Department of Health and Human Services’ Centers for Medicare and Medicaid Services.
The certification confirms that Bluestar Genomics’ laboratory meets the federal regulations for clinical diagnostic testing, ensuring high quality and safety for patient testing. As part of the certification process, Bluestar Genomics recently completed analytical validation evaluating the accuracy and reliability of the company’s early detection test for pancreatic cancer. Top-line results showed significantly stronger performance than previously reported particularly in early-stage (I/II) detection. Full data from the study will be published in a peer-reviewed journal in the coming months.
“Securing CLIA certification is an important step for Bluestar Genomics. It underscores our pancreatic cancer test’s competitive performance, enables us to start clinical testing in our lab and allows us to move forward with larger clinical validation studies,” said David Mullarkey, chief executive officer. “This certification, combined with our growing body of scientific evidence, positions us to become the first cancer detection company to offer clinical epigenomic testing for early pancreatic cancer detection.”
Currently, pancreatic cancer ranks as the third most deadly cancer with a combined five-year survival rate of only 5% to 10%. Research has shown that early detection in pancreatic cancer can increase patient survival nearly ten-fold.
About Bluestar Genomics: Bluestar Genomics is an early cancer detection company focused on the development and commercialization of non-invasive epigenomic tests to detect cancer through a standard blood draw, earlier than existing methods and when the disease is still treatable. The company uses its one-of-a-kind epigenomic platform that combines best-in-class bioinformatics and genomic technologies to analyze individuals’ changing biology that is yet to produce symptoms. Leveraging its novel liquid biopsy technology, Bluestar Genomics is initially focused on high-mortality cancers with the greatest need for early detection, starting with pancreatic and women’s cancers. With locations in San Diego and the San Francisco Bay Area, Bluestar Genomics collaborates with top research institutions and is supported by multiple global healthcare and technology investors and pharmaceutical collaborations.