CLIA certification and CAP accreditation strengthen Astrin’s foundation following launch of Certitude™ Breast, the first non-imaging breast cancer detection blood test that is available in select U.S. markets
ST. PAUL, Minn., April 23, 2026 /PRNewswire/ — Astrin Biosciences has been awarded accreditation by the College of American Pathologists (CAP) Accreditation Committee following the results of on-site inspection. Recognized for its rigorous and robust standards, CAP accreditation underscores Astrin’s commitment to quality, operational excellence, and improved patient outcomes.
In addition to CAP accreditation, Astrin Biosciences is also certified by the Clinical Laboratory Improvement Amendments (CLIA), further demonstrating its adherence to the highest regulatory standards for clinical laboratory testing in the United States. Together, these achievements mark a significant milestone following the launch of Certitude™ Breast, a first-of-its-kind, non-imaging blood test at San Antonio Breast Cancer Symposium. Designed to detect early molecular signals associated with breast cancer, Certitude will expand access to screening beyond traditional imaging and enable a new approach to early cancer detection. Certitude™ Breast is available by prescription in select markets.
“Achieving CAP accreditation, in addition to our CLIA certification, reflects our unwavering commitment to delivering the highest quality diagnostic services,” said Justin Drake, Chief Science Officer, Astrin Biosciences. “These milestones are especially meaningful as we bring Certitude™ Breast into clinical use, ensuring that patients and providers can trust the accuracy, reliability, and clinical rigor behind every result.”
During the CAP accreditation process, inspectors conducted a comprehensive evaluation of Astrin’s St. Paul laboratory’s operations, including quality control procedures, staff qualifications, equipment, facilities, safety programs, and overall management. These inspections are designed to ensure laboratories meet the most current best practices and maintain the highest standards of care for patients.
With the launch of Certitude™, Astrin is helping define a new category of cancer detection—leveraging advanced proteomic analysis to identify early biological signals of disease that may not be captured through conventional screening methods. CAP accreditation further validates the integrity of Astrin’s laboratory operations and its ability to support this innovation with the highest standards of clinical excellence.
For more information about Certitude™ Breast, visit https://www.certitudebloodtest.com/.
About Astrin Biosciences
Astrin is a cancer intelligence company built to push the boundaries of technology that accelerate early detection and advance cancer care. Its non-invasive, accessible cancer tests analyze the early signals in over 9,000 proteins to reveal what most blood tests miss: the earliest molecular signals of cancer development. For more information, visit astrinbio.com.
About the College of American Pathologists
As the world’s largest organization of board-certified pathologists and leading provider of laboratory accreditation and proficiency testing programs, the College of American Pathologists (CAP) serves patients, pathologists, and the public by fostering and advocating excellence in the practice of pathology and laboratory medicine worldwide. For more information, visit the CAP Newsroom, CAP.org and yourpathologist.org to watch pathologists at work and see the stories of the patients who trust them with their care.
Media Contact
Kayli Watson
120/80 MKTG for Astrin Biosciences
kayli@12080group.com
View original content to download multimedia:https://www.prnewswire.com/news-releases/astrin-biosciences-earns-cap-accreditation-for-worlds-first-deep-proteomics-blood-test-for-breast-cancer-detection-302750915.html
SOURCE Astrin Biosciences
