Fueled by new analysis that reinforces the value of Certitude, its potentially ground-breaking breast cancer diagnostic, Astrin Biosciences is increasing its outreach to physicians and preparing to launch direct-to-consumer promotion of its lab-based test.
Their latest paper appears in Breast Cancer: Targets and Therapy. The paper describes how Certitude, which leverages mass spectrometry and machine learning, can detect breast cancer, particularly in its earliest and most treatable stages, with high accuracy.
Certitude may be the first proteomics-based test for breast cancer. It is generated by mass spectroscopy and AI (artificial intelligence), using thousands of datapoints. The test identifies women at high risk of breast cancer, even at very early stages and if they have very dense breast tissue. The test’s launch was announced in December 2025. It is available by prescription only, and is conducted at Astrin’s CLIA-certified and CAP-accredited laboratory.
The new paper reinforces that this test should address a key unmet need—identifying women at high risk of breast cancer when their disease is still easily treatable.
“What gives us the sensitivity that we need is that we can find 7000 proteins per patient from just 100 microliters of plasma,” Justin Drake, PhD, told Inside Precision Medicine. He is corresponding author of the new paper and chief science officer at Astrin Biosciences.
He added, “It’s the depth and breadth of proteomics that allows this capability. We also have unique ways to analyze the protein data from normalization, and we used our machine learning AI classifiers to separate signatures or signals out in breast cancer patients from healthy controls.”
The problem has been, while liquid biopsy tests for cancer are proliferating, most are based on DNA. But, compared to most other cancers, early breast tumors shed only about a tenth of the DNA. So most multi-cancer liquid biopsy tests have low sensitivity in breast malignancy. Currently, even the most sensitive tests leave early breast cancer off their panels.
Certitude reads a protein signal rather than one from DNA.
In its release, Astrin describes how cancer cells constantly signal to immune and stromal cells. 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, providing an early, and accurate, look at the developing cancer.
Astrin’s biomarker was developed using 9,000 proteins. In the validation arm of 397 women, the test achieved a sensitivity of 92.6% and a specificity of 92.3%, with a negative predictive value (NPV) of 99.87%. 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).
Certitude is particularly useful for women with dense breasts. Dense 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.
Besides being able to identify 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. This latest study validates a high-throughput pipeline capable of processing hundreds of samples weekly with exceptional reproducibility.
Drake said, “A paper that came out earlier this year, in Endocrinology, described a case-controlled study in which we found the sensitivity of our tests work equally well across all breast densities.”
“Breast cancer screening has relied on the same imaging techniques for decades. The research published today [July 30] 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 Pooja Advani, MD, medical oncologist and director of the Multidisciplinary Breast Clinic at Mayo Clinic, as quoted in an Astrin press release.
The company intends to further promote Certitude to expand its clinical use and introduce it to direct-to-consumer use. Astrin will also seek to grow its pipeline with new proteomics-based cancer diagnostics tests.
