# Epi proColon (Septin 9 blood test for bowel cancer)

Source: https://onco.cc/drugs/epi-procolon/  
OnCo record `epi-procolon` (Test). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

## Summary

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.

## Fields

- Kind: Test
- Status: approved
- Last checked: 2026-11-04
- Also known as: Septin 9 test; mSEPT9
- Tags: test; screening-test
- Brand: Epi proColon
- Modality: Blood test for methylated Septin 9 DNA (colorectal screening)
- Mechanism: Real-time PCR detects methylated Septin 9 DNA, a marker associated with colorectal cancer, in plasma.
- Approvals: US 2016: Colorectal screening in average-risk adults 50 and older who have declined recommended screening (PMA P130001)

## Sources

- FDA PMA P130001: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P130001

## Connected records

- drugs: [Cologuard](https://onco.cc/drugs/cologuard/), [Shield](https://onco.cc/drugs/shield/), [SimpleScreen CRC](https://onco.cc/drugs/simplescreen-crc/)
- collections: [FDA medical device databases (PMA, 510(k), De Novo)](https://onco.cc/collections/fda-device-databases/)
- cancers: [Colorectal cancer](https://onco.cc/cancers/colorectal/)
- fronts: [Diagnostics & Biomarkers](https://onco.cc/fronts/diagnostics/), [Early Detection & Screening](https://onco.cc/fronts/early-detection/)
- technologies: [Colorectal cancer screening (colonoscopy, FIT, stool DNA, blood)](https://onco.cc/technologies/colorectal-screening/)
- terms: [Screening](https://onco.cc/terms/screening/)

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