Published study reports >92% sensitivity and specificity, outperforming current standards for supplemental screening
SAINT PAUL, Minn., July 30, 2026 /PRNewswire/ — Astrin Biosciences, a cancer intelligence company transforming how cancer is detected and treated through deep proteomics and AI, today announced the publication of a landmark peer-reviewed study, “Development and Validation of a Machine-Learning Deep Plasma Proteome Classifier for Early Stage Breast Cancer Detection.” The study demonstrates high sensitivity and specificity of the first blood test for early breast cancer detection.
This research, initially presented in December 2025 at the San Antonio Breast Cancer Symposium, reflects the validation of Astrin’s novel proteome-based liquid biopsy test for early-stage breast cancer detection. In this paper published in Breast Cancer: Targets and Therapy, Astrin demonstrates that Certitude, which leverages mass spectrometry and machine learning, achieves high accuracy in identifying breast cancer, particularly in its earliest and most treatable stages.
For decades, liquid biopsies have leaned on DNA-based blood tests — an approach that has struggled for breast cancer for a simple biological reason: early breast tumors shed only about a tenth of the DNA compared to other cancers, including colorectal. That is why DNA-based multi-cancer tests have shown low sensitivity in breast disease, and why even the most sensitive tests leave early breast cancer off their panels entirely. Certitude reads a different signal in proteins rather than DNA. Cancer cells don’t grow in isolation — they constantly signal to immune and stromal cells, and that protein crosstalk appears in the blood long before a tumor is large enough to image. By profiling the proteome in depth, Certitude surfaces those faint early signals, closing a gap that imaging and DNA-based blood tests have never fully solved.
Astrin’s patent-pending proteomics approach captures a deep profile of over 9,000 proteins to identify cancer-specific signals. In the validation arm of 397 women, the test achieved a sensitivity of 92.6% and a specificity of 92.3%, with a remarkably high negative predictive value (NPV) of 99.87%. These results were consistent across all breast cancer stages (0-IV) and across various molecular and pathological subtypes, including the notoriously difficult-to-detect Invasive Lobular Carcinoma (ILC).
“Our proteomic assay demonstrates high sensitivity and specificity in women with breast cancer, especially at early stages,” said Justin Drake, Ph.D., Corresponding Author and Chief Science Officer at Astrin Biosciences. “By reducing false positives more than 10-fold compared to MRIs or contrast enhanced mammograms, Certitude represents a promising path forward as a supplemental screening option that is convenient and accessible.”
For women with dense breasts, Certitude offers more clarity than ever before. Dense tissue appears white on a mammogram — and so can abnormalities, including some cancers — which can make it more difficult for radiologists to detect changes or suspicious areas. In addition to identifying cancers in pathological stages 0, I, and II with high accuracy, Certitude detected 93% of breast cancers in women with dense breast tissue across a simulated population, many of which could have been missed by traditional mammography. The study validates a high-throughput pipeline capable of processing hundreds of samples weekly with exceptional reproducibility.
“Breast cancer screening has relied on the same imaging techniques for decades. The research published today represents a real step forward for women, showing that a proteomic-based blood test can detect earliest signals of breast cancer with high confidence,” said Dr. Pooja Advani, Medical Oncologist and Director of the Multidisciplinary Breast Clinic at Mayo Clinic.
Certitude is intended for women following screening mammography who require additional risk stratification before further imaging. The test is most appropriate for:
- Women ages ≥40 with dense breasts (BI-RADS C or D) and a negative mammogram
- Patients with inconclusive or indeterminate mammographic findings (e.g., BI-RADS 0 or 3)
- High-risk patients with negative or equivocal mammogram, used as part of high-risk screening rotation
- Suspicious or positive findings (BI-RADS 3 or 4)
To learn more or request the test, go to www.certitudetest.com.
About Astrin Biosciences
Astrin Biosciences is a biotechnology company based in Saint Paul, MN, dedicated to revolutionizing cancer diagnostics through deep proteome profiling. By combining advanced mass spectrometry with proprietary machine learning algorithms, Astrin is developing highly sensitive, non-invasive tests to detect cancer at its earliest stages, with a mission to end cancer as we know it. Astrin Biosciences Laboratories is accredited by CAP, certified under CLIA regulations, and qualified to perform high-complexity clinical laboratory testing.
Media Contact
Jenny Edelston
120/80 MKTG on behalf of Astrin Biosciences
[email protected]
View original content:https://www.prnewswire.com/news-releases/peer-reviewed-study-validates-first-blood-test-for-early-stage-breast-cancer-detection-302839173.html
SOURCE Astrin Biosciences
