The accreditation supports the company’s proteomics-based test designed to detect early breast cancer signals without traditional imaging.

Astrin Biosciences has received accreditation from the College of American Pathologists (CAP) Accreditation Committee following an on-site inspection of its facility in St Paul, Minnesota. The achievement follows the launch of Certitude Breast, a non-imaging blood test designed to identify early molecular signals associated with breast cancer.

In addition to the CAP accreditation, Astrin Biosciences is certified under the Clinical Laboratory Improvement Amendments (CLIA). These regulatory milestones support the clinical use of Certitude Breast, which is available by prescription in select US markets. The test is designed to expand access to screening by identifying biological signals that may not be captured through conventional imaging methods.

“Achieving CAP accreditation, in addition to our CLIA certification, reflects our unwavering commitment to delivering the highest quality diagnostic services,” says Justin Drake, chief science officer at Astrin Biosciences, in a release. “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 accreditation process, inspectors conducted what the company described as a “comprehensive evaluation” of laboratory operations. This process included a review of quality control procedures, staff qualifications, equipment, facilities, safety programs, and overall management. The CAP inspections are intended to ensure that clinical laboratories meet current best practices and maintain high standards of patient care.

The Certitude Breast test utilizes advanced proteomic analysis to detect disease. By analyzing early signals in more than 9,000 proteins, the technology identifies molecular changes associated with cancer development. According to the company, this approach allows for the detection of early biological signals that are often missed by other types of blood tests.

The CAP accreditation further validates the operational integrity of the laboratory as it moves forward with the commercial availability of its testing services. As the world’s largest organization of board-certified pathologists, CAP provides accreditation and proficiency testing to foster excellence in the practice of pathology and laboratory medicine.

ID 432691609 | Accreditation © Zhanna Hapanovich | Dreamstime.com

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