# SimpleScreen CRC

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

## TL;DR

The second FDA-approved blood test for bowel cancer screening, from Freenome, sold by Abbott from late 2026.

## Summary

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.

## Fields

- Kind: Treatment
- Status: approved
- Last checked: 2026-09-24
- Tags: test
- Brand: SimpleScreen
- Modality: Blood-based colorectal cancer screening test (cfDNA methylation and protein)
- Mechanism: Multiomics plasma assay combining cell-free DNA methylation with protein biomarkers and machine learning to classify colorectal cancer signal.
- Approvals: US 2026: Colorectal cancer screening in average-risk adults aged 45 and older

## Notes

- 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.

## Sources

- PREEMPT CRC (JAMA 2025): https://doi.org/10.1001/jama.2025.7515
- FDA approval (MedTech Dive): https://www.medtechdive.com/news/freenome-secures-fda-nod-for-blood-based-colorectal-cancer-test/826290/
- Freenome: https://www.freenome.com

## Connected records

- drugs: [Cologuard Plus](https://onco.cc/drugs/cologuard-plus/), [Shield](https://onco.cc/drugs/shield/)
- cancers: [Colorectal cancer](https://onco.cc/cancers/colorectal/)
- technologies: [Colorectal cancer screening (colonoscopy, FIT, stool DNA, blood)](https://onco.cc/technologies/colorectal-screening/), [DNA methylation profiling](https://onco.cc/technologies/methylation-profiling/), [Liquid biopsy (ctDNA)](https://onco.cc/technologies/liquid-biopsy/)
- companies: [Abbott Laboratories](https://onco.cc/companies/abbott/), [Freenome](https://onco.cc/companies/freenome/)
- terms: [Cell-free DNA (cfDNA)](https://onco.cc/terms/cfdna/), [Screening](https://onco.cc/terms/screening/), [Sensitivity and specificity](https://onco.cc/terms/sensitivity-specificity/)
- trials: [PREEMPT CRC](https://onco.cc/trials/preempt-crc/)
- key papers: [Clinical validation of a circulating tumor DNA-based blood test to screen for colorectal cancer (PREEMPT CRC)](https://onco.cc/key-papers/paper-preempt-crc-shaukat-jama-2025/)

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JSON: https://onco.cc/api/v1/entities/simplescreen-crc.json