# SimpleScreen CRC by Freenome

Canonical page: https://technooptimist.io/biotech/simplescreen-crc
Frontier: [Biotech](https://technooptimist.io/biotech.md) · Field: Cancer DNA tests · Company: [Freenome](https://technooptimist.io/companies/freenome.md)
Stage: Deploy (4 of 5: Research → Proto → Pilot → Deploy → Scaling)
Updated: last update 2026-07-27, facts checked 2026-10-11
Goal: Get people who skip colonoscopy and stool tests screened with a simple blood draw, catching colorectal cancer while it is still curable.
Status: FDA approved July 2026; Abbott launching in the US this autumn; upgraded version to follow.
Next milestone: Abbott US commercial launch, target Q4 2026

## Milestones

| Status | Milestone | Date | Slip |
| --- | --- | --- | --- |
| Done | PREEMPT CRC pivotal study (48,995 adults) results |   |   |
| Done | Final FDA submission module; Exact Sciences license | Aug 2025 |   |
| Done | American Cancer Society guideline adds blood tests | May 2026 |   |
| Done | FDA approval | 27 Jul 2026 |   |
| Current | Abbott US commercial launch | Q4 2026 |   |
| Planned | Next-generation version submitted as a PMA supplement |   |   |

## Upcoming events

- **Q4 2026**: Abbott US commercial launch

## Most important updates

- **27 Jul 2026**: FDA approves Freenome's SimpleScreen CRC blood test; Abbott to market it in the US. The FDA approved SimpleScreen CRC for average-risk adults aged 45 and older, making it the second blood-based colorectal screening test after Guardant Health's Shield. ([our story](https://technooptimist.io/stories/fda-approves-freenome-s-simplescreen-crc-blood-test-abbott-to-market-it-65f898d2.md) · [original source](https://medtechdive.com/news/freenome-secures-fda-nod-for-blood-based-colorectal-cancer-test/826290))
- **6 Aug 2025**: Freenome licenses its colorectal blood test to Exact Sciences in a deal worth up to $885M. Freenome gave Exact Sciences, maker of the Cologuard stool test, exclusive rights to sell its blood-based colorectal screening test, and submitted the final module of its FDA application. ([our story](https://technooptimist.io/stories/freenome-licenses-its-colorectal-blood-test-to-exact-sciences-in-a-deal-5f1df735.md) · [original source](https://www.freenome.com/newsroom/freenome-announces-exclusive-license-agreement-with-exact-sciences-to-commercialize-freenomes-blood-based-screening-test-for-colorectal-cancer/))

## Current obstacles

- **Misses most precancers**: Finds only 13.7% of advanced precancerous lesions, so unlike colonoscopy it rarely prevents cancer.
- **Guideline and payer status**: A $500M milestone hinges on a USPSTF A or B rating; ACS lists blood tests only for people who decline other tests.

## Physics limits

- **Too little tumour DNA early on**: Small, early tumours and polyps shed almost no DNA into blood, so blood tests are physically limited in catching the earliest, most curable lesions.
- **Specificity costs colonoscopies**: At 90% specificity, about 1 in 10 healthy people screened gets a false alarm and a colonoscopy, a trade-off that grows with population screening.

## How it works

### Shed DNA: Tumours leak DNA into blood

Dying cancer cells release DNA fragments; a few copies circulate among billions from healthy cells.

### Methylation: Read the chemical tags

Cancer DNA carries distinctive methyl marks; the test reads them at single-letter resolution.

### Multiomics + AI: Combine signals

Machine-learning models weigh DNA and other blood markers to call a sample positive or negative.

### Follow-up: Positive means colonoscopy

The test triages; a colonoscopy confirms and removes polyps or cancer.

## Spec sheet

| Spec | SimpleScreen CRC | Provenance |
| --- | --- | --- |
| Colorectal cancer detected | 81.1% | reported |
| Stage I cancers detected | 63.5% | reported |
| Advanced precancerous lesions detected | 13.7% | reported |
| Specificity | 90.4% | reported |
| PREEMPT CRC participants | 48,995 | reported |

Provenance: reported = stated by the company; estimated = our estimate; sample = a sample figure.

## About Freenome

Brisbane, California company that reads DNA methylation and other signals in blood to screen for cancer. Its colorectal test SimpleScreen won FDA approval in July 2026 and is sold by Abbott.

- SimpleScreen CRC: FDA approved 27 Jul 2026 for average-risk adults 45+, the second blood test after Guardant's Shield.
- Abbott (which bought Exact Sciences) sells it in the US; deal worth up to $885M to Freenome.
- Listed on Nasdaq (FRNM) in July 2026 via a SPAC, raising about $310M.

- Headquarters: US
- Status: public
- Last round: SPAC merger + PIPE $310M, Jul 2026, led by Perceptive Advisors, RA Capital
- Website: https://www.freenome.com
- People: Aaron Elliott (Chief Executive Officer); Riley Ennis (Co-founder, Chief Product Officer)
- Partners, customers, investors: Abbott (partner)

Company page: https://technooptimist.io/companies/freenome.md

## Related programs

Everything in Biotech: https://technooptimist.io/biotech.md

---

The Techno Optimist tracks every frontier of technology, program by program: https://technooptimist.io/ (a Markdown version of any page: add .md to its URL; site map for agents: https://technooptimist.io/llms.txt).
Data API (JSON, realtime stream): https://technooptimist.io/developers. People read 5 pages free, then Reader $10/month; these Markdown pages are open to agents.