Cancer intelligence company Astrin Biosciences published a peer-reviewed study in Breast Cancer: Targets and Therapy validating its blood test for early-stage breast cancer detection.
Unlike DNA-based liquid biopsies, Astrin’s test, Certitude, uses machine learning to analyze over 9,000 plasma proteins for cancer-associated patterns. In a validation study of 397 banked blood samples, the test detected 92.6% of breast cancer cases, correctly identified 92.3% of women without breast cancer, and achieved a 99.87% negative predictive value. The study also reported strong performance across breast cancer stages (0-IV) and in women with dense breast tissue.
The blood test is designed to complement mammography by providing additional risk stratification for women with dense breasts, inconclusive imaging results, or elevated breast cancer risk.
“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.”
Certitude is available through Astrin’s CLIA-certified, CAP-accredited lab. Additional prospective clinical studies will likely be needed before broader clinical adoption.
