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The first FDA-approved blood test for bowel cancer screening (2016), meant only for people who have been offered and declined the recommended screening tests.
The FDA approved Epi proColon on 12 April 2016 (PMA P130001; current applicant New Day Diagnostics). It detects methylated Septin 9 DNA in plasma by real-time PCR and is indicated "to screen adults of either sex, 50 years or older, defined as average risk for CRC, who have been offered and have a history of not completing CRC screening"; tests recommended in the USPSTF 2008 guidelines should be offered and declined first, and a positive result should be followed by diagnostic colonoscopy. Later blood tests (Shield in 2024, SimpleScreen CRC in 2026) were approved as screening options for average-risk adults without that restriction.
Real-time PCR detects methylated Septin 9 DNA, a marker associated with colorectal cancer, in plasma.
| Region | Year | Indication |
|---|---|---|
| US | 2016 | Colorectal screening in average-risk adults 50 and older who have declined recommended screening (PMA P130001) |
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Query for this drug: (TITLE:"Epi proColon" OR ABSTRACT:"Epi proColon" OR TITLE:"Septin 9 blood test for bowel cancer" OR ABSTRACT:"Septin 9 blood test for bowel cancer" OR TITLE:"Septin 9 test" OR ABSTRACT:"Septin 9 test" OR TITLE:"mSEPT9" OR ABSTRACT:"mSEPT9") 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 Epi proColon (Septin 9 blood test for bowel cancer), not a curated reading list.
Shares Cologuard, FDA medical device databases (PMA, 510(k), De Novo), Colorectal cancer screening (colonoscopy, FIT, stool DNA, blood), Screening and the tags test, screening-test.
Shares FDA medical device databases (PMA, 510(k), De Novo), Screening and the tags test, screening-test.
Shares FDA medical device databases (PMA, 510(k), De Novo), Screening and the tags test, screening-test.
Shares FDA medical device databases (PMA, 510(k), De Novo), Screening and the tags test, screening-test.
Shares FDA medical device databases (PMA, 510(k), De Novo), Screening and the tags test, screening-test.
Shares FDA medical device databases (PMA, 510(k), De Novo), Screening and the tags test, screening-test.
Shares FDA medical device databases (PMA, 510(k), De Novo), Screening and the tags test, screening-test.
Shares FDA medical device databases (PMA, 510(k), De Novo), Screening and the tags test, screening-test.
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