Developed by Saint Paul-based Astrin Biosciences, the test utilizes mass spectrometry and machine learning to scan over 9,000 proteins. Traditional DNA-based liquid biopsies frequently struggle with breast cancer because early tumors release significantly less DNA than other malignancies. The Certitude approach focuses on the protein crosstalk between cancer and surrounding immune cells, allowing for detection before a tumor becomes visible on standard imaging.

In a validation study of 397 women, the test demonstrated a specificity of 92.3% and a negative predictive value of 99.87%. These results remained consistent across all cancer stages, including difficult-to-detect Invasive Lobular Carcinoma. Dr. Justin Drake, Chief Science Officer at Astrin, noted that the assay reduces false positives by more than 10-fold when compared to conventional MRIs or contrast-enhanced mammograms.

For patients with dense breast tissue, where mammograms often struggle to distinguish between healthy tissue and abnormalities, the test identified 93% of cancers in a simulated population. The technology is intended as a supplemental screening tool for women over 40 who require further risk stratification after an inconclusive or negative mammographic finding. Dr. Pooja Advani of the Mayo Clinic stated the research provides a significant shift from the imaging-reliant protocols that have dominated breast cancer screening for decades.