Proteomics is gaining traction in oncology, and Astrin Biosciences is moving quickly to capitalize on that momentum with its Certitude breast cancer test. The company is ramping up efforts to get the test into doctors’ offices and is preparing for a direct-to-consumer launch, fueled by a new study that highlights the test’s capabilities.
Astrin’s Certitude leverages mass spectrometry and artificial intelligence to analyze proteins in the blood. It aims to detect breast cancer, especially in early stages, with high accuracy. The test identifies high-risk women, even if they have dense breast tissue, a condition that often obscures tumors on standard mammograms.
Current liquid biopsy tests usually look for DNA, but early breast tumors shed very little of it. This makes DNA-based tests less sensitive for breast cancer compared to other malignancies. Certitude relies on proteins instead, which cancer cells release into the blood long before a mass is large enough to be seen on an X-ray.
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Justin Drake, PhD, the chief science officer at Astrin and corresponding author of the new paper, explained the technology. He noted that the test finds 7,000 proteins from just 100 microliters of plasma. This depth of data allows the machine learning AI classifiers to separate cancer signals from healthy controls effectively.
In a validation study involving 397 women, Certitude achieved a sensitivity of 92.6% and a specificity of 92.3%. The negative predictive value was notably high at 99.87%. The results held consistent across all breast cancer stages and subtypes, including Invasive Lobular Carcinoma, which is notoriously difficult to detect.
A Challenge for Radiology
Women with dense breast tissue face a specific diagnostic hurdle. Mammograms show dense tissue as white, just like cancerous masses. This overlap can hide small tumors, leading to false negatives or delayed diagnoses. Astrin’s test aims to bridge this gap.
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According to the company, the test detected 93% of breast cancers in women with dense tissue across a simulated population. Many of these cases would likely have been missed by traditional imaging. The company also published a separate study in Endocrinology confirming that the test performs equally well regardless of breast density.
While the results look promising, the path forward involves handling a complex regulatory and market environment. A paper published earlier this year suggested the technology works well across different densities, but widespread clinical adoption will require more than just technical accuracy. Insurance reimbursement policies and physician adoption rates will play a massive role in determining whether this proteomic approach becomes a standard of care or remains a niche tool for high-risk patients.
The test is available by prescription at Astrin’s CLIA-certified laboratory. It is expected to be available directly to consumers later this year.
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