Astrin Biosciences is expanding physician outreach and preparing a direct-to-consumer launch for Certitude, a proteomic-based breast cancer diagnostic test that leverages mass spectrometry and machine learning. According to the company, the test identifies high-risk patients and detects early-stage malignancies from a small plasma sample.
How Proteomics and AI Outperform Traditional DNA Liquid Biopsies in Early Detection
Most multi-cancer liquid biopsy tests rely on DNA. However, early-stage breast tumors shed only about a tenth of the DNA compared to other cancers, leaving early breast malignancies off standard panels, according to research cited by Astrin Biosciences. To solve this, Certitude analyzes proteins rather than DNA. According to Justin Drake, chief science officer at Astrin Biosciences, the test finds 7,000 proteins per patient from just 100 microliters of plasma. As Drake told Inside Precision Medicine, analyzing this depth and breadth of proteomics using machine learning AI classifiers allows the company to separate signals in breast cancer patients from healthy controls.
Clinical Validation Data and Performance Across Breast Densities
In a validation arm of 397 women, Certitude achieved a sensitivity of 92.6% and a specificity of 92.3%, with a negative predictive value of 99.87%, according to data published in Breast Cancer: Targets and Therapy. The biomarker was developed using 9,000 proteins. Results remained consistent across stages 0 through IV and across molecular subtypes, including Invasive Lobular Carcinoma (ILC). Furthermore, according to a case-controlled study published earlier in the year in Endocrinology and cited by Drake, the test’s sensitivity works equally well across all breast densities.
Pro Tip: Dense breast tissue appears white on a mammogram—and so can abnormalities, including some cancers, making it more difficult for radiologists to detect changes or suspicious areas. Proteomic blood tests like Certitude operate independently of tissue density, offering an alternative screening avenue for high-risk patients.
Expert Perspectives on Next-Generation Breast Cancer Screening
Medical professionals note that imaging technologies have remained largely unchanged for decades. Pooja Advani, medical oncologist and director of the Multidisciplinary Breast Clinic at Mayo Clinic, stated in an Astrin press release that the research published on July 30 represents a real step forward for women, showing that a proteomic-based blood test can detect the earliest signals of breast cancer with high confidence.
Frequently Asked Questions
What sample size does Certitude require?
According to Astrin Biosciences, the test requires 100 microliters of plasma.
How is Certitude administered?
The test is available by prescription only and is conducted at Astrin’s CLIA-certified and CAP-accredited laboratory.
Can Certitude detect cancer in dense breast tissue?
Yes. According to company validation data, the test detected 93% of breast cancers in women with dense breast tissue across a simulated population.
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