SimpleScreen CRC by Freenome: status and timeline

SimpleScreen CRC

Get people who skip colonoscopy and stool tests screened with a simple blood draw, catching colorectal cancer while it is still curable.

DeployStage 4 of 5

FDA approved July 2026; Abbott launching in the US this autumn; upgraded version to follow.

Updated 27 Jul 2026Checked 11 Oct0 updates this week

Milestones

Next · Abbott US commercial launch

PREEMPT CRC pivotal study (48,995 adults) resultsDoneComplete.
Final FDA submission module; Exact Sciences licenseAug 2025Complete.
American Cancer Society guideline adds blood testsMay 2026Complete.
FDA approval27 Jul 2026Complete.
Abbott US commercial launchTarget Q4 2026Current milestone.
Next-generation version submitted as a PMA supplementNot yet reached.

Most important updates

Upcoming

Q4 2026Abbott US commercial launch (next)

Current obstacles

Misses most precancersFinds only 13.7% of advanced precancerous lesions, so unlike colonoscopy it rarely prevents cancer.
Guideline and payer statusA $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 onSmall, 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 colonoscopiesAt 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

4 parts

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
Colorectal cancer detected	81.1%^R (reported)
Stage I cancers detected	63.5%^R (reported)
Advanced precancerous lesions detected	13.7%^R (reported)
Specificity	90.4%^R (reported)
PREEMPT CRC participants	48,995^R (reported)

^R reported by the company

Update log

2 updates

Mon 27 Jul

Major: FDA approves Freenome's SimpleScreen CRC blood test; Abbott to market it in the USPressRegulatory

Wed 6 Aug 2025

Major: Freenome licenses its colorectal blood test to Exact Sciences in a deal worth up to $885MPressPartnership

About Freenome

The team behind SimpleScreen CRC

Freenome

Blood tests for cancer screening, SimpleScreen CRC

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.

freenome.com (opens freenome.com)Company profile →

Headquarters: United States
Status: Public
Valuation: public
Last round: SPAC merger + PIPE · $310MJul 2026
Works in: BiotechCancer DNA tests
Coverage: 1 program · 3 updateslatest 27 Jul 2026checked 11 Oct
Lead investors: Perceptive AdvisorsRA Capital
Partners: Abbott
People: Aaron ElliottChief Executive OfficerRiley EnnisCo-founder, Chief Product Officer

Spec

SimpleScreen CRC

Colorectal cancer detected

81.1%^R (reported)

Stage I cancers detected

63.5%^R (reported)

Advanced precancerous lesions detected

13.7%^R (reported)

Specificity

90.4%^R (reported)

PREEMPT CRC participants

48,995^R (reported)