ST. PAUL, Minn., April 23, 2026

Astrin Biosciences announced that it has received accreditation from the College of American Pathologists (CAP), alongside Clinical Laboratory Improvement Amendments (CLIA) certification, marking a major milestone following the launch of its Certitude™ Breast test, the world’s first deep proteomics-based, non-imaging blood test for breast cancer detection. These regulatory achievements reinforce the company’s commitment to clinical quality, diagnostic accuracy, and patient safety, while advancing a new paradigm in early cancer detection.

CAP Accreditation Validates Clinical Quality and Excellence

The CAP accreditation follows a comprehensive on-site inspection of Astrin’s laboratory operations, evaluating quality control systems, laboratory processes, staff qualifications, equipment standards, and safety protocols. Recognized globally as a benchmark for laboratory excellence, CAP accreditation confirms that Astrin meets rigorous clinical and operational standards, ensuring reliable and reproducible diagnostic results. Combined with CLIA certification, these credentials demonstrate that Astrin’s laboratory infrastructure is aligned with the highest regulatory requirements for clinical testing in the United States, providing confidence to both healthcare providers and patients. This dual recognition is particularly critical as the company expands access to its innovative cancer detection technologies in real-world clinical settings.

Certitude™ Breast Introduces a New Era in Cancer Detection

Astrin’s Certitude™ Breast test represents a breakthrough in breast cancer screening, offering a non-invasive, blood-based alternative to traditional imaging methods. Unlike conventional diagnostics, the test leverages advanced deep proteomics analysis, examining over 9,000 proteins to identify early molecular signals associated with cancer development. This approach enables detection of disease at earlier stages, potentially before tumors are visible through imaging technologies such as mammography. By expanding access to screening through a simple blood test, Certitude™ Breast addresses key limitations of current screening approaches, including accessibility barriers, patient compliance challenges, and variability in imaging sensitivity. The test is currently available by prescription in select U.S. markets, signaling the beginning of a new category in precision cancer diagnostics..

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Advancing Early Detection and Patient Outcomes

The integration of deep proteomics with clinical diagnostics positions Astrin at the forefront of next-generation oncology innovation, where early detection plays a critical role in improving survival rates and treatment outcomes. Breast cancer remains one of the most prevalent cancers worldwide, and early identification is essential for effective intervention and reduced mortality. By enabling clinicians to detect subtle biological changes before clinical symptoms appear, Astrin’s technology has the potential to transform screening strategies and enhance preventive care.

Furthermore, CAP accreditation strengthens the company’s ability to scale its diagnostic platform, ensuring that innovation is supported by robust clinical validation and regulatory compliance. This combination of cutting-edge science and operational excellence is essential for building trust in emerging diagnostic technologies and driving broader adoption across healthcare systems.

Astrin Biosciences’ latest achievement underscores the growing importance of advanced diagnostics in precision medicine, where data-driven insights and molecular-level analysis are redefining how diseases are detected and managed. As the company continues to expand its footprint, its focus on quality, innovation, and accessibility is expected to play a significant role in shaping the future of early cancer detection and personalized healthcare.

Source: Astrin Biosciences press release