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The second FDA-approved blood test for bowel cancer screening, from Freenome, sold by Abbott from late 2026.
Freenome's blood test was approved by the FDA on 24 July 2026 for average-risk adults aged 45 and older, based on the PREEMPT CRC study of more than 48,000 participants, in which sensitivity for colorectal cancer was 79.2%, specificity for advanced neoplasia 91.5%, and sensitivity for advanced precancerous lesions 12.5% (JAMA 2025). Abbott holds US commercial rights. Like Shield, the test is intended for people who decline stool tests or colonoscopy: guidelines still rank it below colonoscopy and FIT because it misses most precancerous polyps and therefore prevents fewer cancers.
Multiomics plasma assay combining cell-free DNA methylation with protein biomarkers and machine learning to classify colorectal cancer signal.
1.SimpleScreen CRC slips into a pocket on its target.
| Region | Year | Indication |
|---|---|---|
| US | 2026 | Colorectal cancer screening in average-risk adults aged 45 and older |
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Query for this drug: (TITLE:"SimpleScreen CRC" OR ABSTRACT:"SimpleScreen CRC" OR TITLE:"SimpleScreen" OR ABSTRACT:"SimpleScreen") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about SimpleScreen CRC, not a curated reading list.
Shares Cologuard Plus, Shield, Screening, Colorectal cancer screening (colonoscopy, FIT, stool DNA, blood) and the tag test.
Shares Shield, Screening, DNA methylation profiling, Liquid biopsy (ctDNA) and the tag test.
Shares DNA methylation profiling, Liquid biopsy (ctDNA), Colorectal cancer and the tag test.
Shares Abbott Laboratories and the tag test.
Shares Sensitivity and specificity and the tag test.
Shares Liquid biopsy (ctDNA), Colorectal cancer and the tag test.
Shares Liquid biopsy (ctDNA) and the tag test.
Shares Liquid biopsy (ctDNA) and the tag test.