NEW YORK — Cancer detection technology firm Bluestar Genomics said on Monday that it has received Clinical Laboratory Improvement Amendments certification from the US Centers for Medicare and Medicaid Services.
As part of the certification process, Bluestar completed analytical validation evaluating the accuracy and reliability of the company’s liquid biopsy-based early detection test for pancreatic cancer, the San Diego-based company said. Top-line results from that validation showed stronger performance than previously reported, particularly in early-stage disease.
Bluestar said that it intends to publish full data from the study in a peer-reviewed journal in the coming months.
"Securing CLIA certification … 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," Bluestar CEO David Mullarkey said in a statement.
Earlier this year, Bluestar presented data from a performance evaluation of its epigenomic pancreatic cancer test that showed 55 percent sensitivity and 98 percent specificity in a cohort of 1,433 patients with new-onset diabetes.