SimpleScreen CRC
The second FDA-approved blood test for bowel cancer screening, from Freenome, sold by Abbott from late 2026.
Overview
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.
Approvals
| Region | Year | Indication |
|---|---|---|
| US | 2026 | Colorectal cancer screening in average-risk adults aged 45 and older |
Trials
topRecruiting now (live from ClinicalTrials.gov)
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Notes
top- What a result means: a positive result needs a colonoscopy; a negative result is reassuring for cancer but says little about polyps, so the test should be repeated on schedule.
Latest papers
topQuery 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.
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