On June 6, 2022 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, reported 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 (Press release, Bluestar Genomics, JUN 6, 2022, View Source [SID1234615663]).

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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.