FDA approves SimpleScreen CRC as second blood-based colorectal cancer screening test
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- 4 de ago.
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The test gives average-risk adults aged 45 years and older an additional screening option, but positive results still require colonoscopy and the assay is not intended for high-risk surveillance.
The US Food and Drug Administration has approved Freenome’s SimpleScreen CRC, a blood-based in vitro diagnostic test for colorectal cancer screening in average-risk adults aged 45 years and older, making it the second FDA-approved blood test for this purpose.
The approval may help clinicians engage patients who have not completed established screening, although the test has limited detection of advanced precancerous lesions and does not replace diagnostic or surveillance colonoscopy.
Field | Content |
Alert Type | Drug Approval |
Drug Name | SimpleScreen CRC |
Indication | Colorectal cancer screening in adults aged 45 years and older who are at average risk for the disease; patients with a positive result should undergo follow-up colonoscopy. |
Therapy Area(s) | Oncology; Gastroenterology; Cancer screening |
Geography | United States (FDA) |
What Happened | On 24 July 2026, the FDA granted premarket approval to SimpleScreen CRC, a qualitative in vitro diagnostic test developed by Freenome that detects molecular signals associated with colorectal cancer using circulating cell-free DNA from plasma. The approval adds a second blood-based colorectal cancer screening test for average-risk adults aged 45 years and older; it is not a replacement for diagnostic colonoscopy or surveillance colonoscopy in high-risk individuals. Abbott plans to commercialise the test in the United States from autumn 2026. (FDA Access Data) |
Why It Matters | SimpleScreen CRC provides another screening route for eligible adults who may decline or fail to complete colonoscopy or stool-based testing. This could support wider screening participation, but clinicians must explain that an abnormal result requires colonoscopy and that blood-based testing is less effective at identifying precancerous lesions than established screening approaches. (investors.freenome.com) |
Supporting Context | In the PREEMPT CRC study of more than 48,000 asymptomatic, average-risk adults, SimpleScreen CRC demonstrated 81.1% sensitivity for colorectal cancer, 13.7% sensitivity for advanced precancerous lesions and 90.4% specificity for advanced colorectal neoplasia. These results mean the test detected approximately eight in ten cancers but identified a much smaller proportion of advanced precancerous lesions. (investors.freenome.com) |
Key Takeaway | SimpleScreen CRC expands blood-based screening choice for average-risk adults, but it should complement rather than replace higher-performing screening and appropriate colonoscopy follow-up. |
What to Watch | Commercial availability from autumn 2026, incorporation into clinical screening pathways and whether increased convenience translates into higher completion rates among people overdue for colorectal cancer screening. |
Primary Source | |
Relevant Date | 24 July 2026 |
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