- No public price.
- Not disclosed
- Not disclosed
- —
- 2014
- US
Pathology
Freenome
by Freenome · founded 2014 · US
FDA-approved SimpleScreen CRC blood test for colorectal cancer screening in adults 45 and older at average risk.
On this page
40/100
Editorial rating 3.0 / 5
- Regulatory & Compliance18/28
FDA cleared (1 K-number on record)
- Clinical Integration0/6.6
No EHR integrations listed
- Evidence Strength0/28.8
No peer-reviewed coverage
- Vendor & Market14.4/18
Mid-tier funding and adoption
- Sentiment & Transparency2.5/5
Pricing on request, no public amounts
▸ Show all 11 dimensions▾ Hide dimension detail
- FDA clearance18/18
FDA cleared (1 K-number on record)
- HIPAA / SOC2 / BAA0/10
No public HIPAA/SOC2/BAA attestation
- EHR integrations (count)0/4
No EHR integrations listed
- Top-3 EHR coverage (Epic / Oracle / Athena)0/2
None of the top-3 EHRs covered
- Peer-reviewed papers0/21
No peer-reviewed coverage
- RCT / meta-analysis / systematic review0/8
No RCT, meta-analysis, or systematic review
- Funding & adoption signal8/12
Mid-tier funding and adoption
- Years in market6/6
Founded 2014 (12 years)
- Pricing transparency3/5
Pricing on request, no public amounts
FDA-approved SimpleScreen CRC blood test for colorectal cancer screening in adults 45 and older at average risk.
No public price.
Evidence record
PMAP250029 (opens in new tab)July 24, 2026
SimpleScreen CRC
- Score computed November 2, 2026, method 1.2.0
- Review written November 2, 2026
MedAI Verdict, Freenome record, https://medaiverdict.com/tools/freenome, version November 2, 2026
Bottom line
FDA approved Freenome's SimpleScreen CRC under PMA P250029 on July 24, 2026 as a qualitative blood test on cell-free DNA for colorectal cancer screening in adults 45 and older at average risk, with colonoscopy following a positive result. Freenome's release of July 27, 2026 says Abbott will commercialize the test exclusively in the US starting this fall. The test fits average-risk adults in the indicated age band. Freenome reports a sensitivity of 81.1% for colorectal cancer and 13.7% for advanced precancerous lesions, so a buyer whose priority is those lesions is looking at the lower figure.
What is the test approved to do?
The FDA generic name is "System, colorectal neoplasia, DNA methylation and hemoglobin detection". Freenome describes its work as blood-based screening that uses multiomics, AI and machine learning, and SimpleScreen is the first of a SimpleScreen portfolio. The approved indication is screening of adults 45 and older at average risk, and a positive result is followed by colonoscopy.
What performance does Freenome report?
Freenome reports prespecified results of 81.1% sensitivity for colorectal cancer, 13.7% for advanced precancerous lesions and 30.7% for lesions with high-grade dysplasia. Specificity for advanced colorectal neoplasia is reported at 90.4%. The release describes the PREEMPT CRC trial as enrolling more than 48,000 asymptomatic average-risk adults aged 45 to 85 at over 200 sites.
A 2025 JAMA paper titled "Clinical Validation of a Circulating Tumor DNA-Based Blood Test to Screen for Colorectal Cancer" has a Freenome-affiliated author, and the validation is vendor-run. Its link to PREEMPT CRC is unverified. A 2026 review of blood-based colorectal cancer tests in Gastrointestinal Endoscopy Clinics of North America (PMID 42692772) covers the Freenome test alongside Guardant Shield, Exact Sciences Cologuard and Epi proColon.
Who sells the test to clinicians?
Freenome develops the test, and the approval release says Abbott will commercialize it exclusively in the US. The release says Abbott pays Freenome a $100 million milestone for the approval. Freenome says it was founded in 2014, and a $254M round on February 15, 2024 was led by Roche. The company has traded on the Nasdaq Capital Market as FRNM since July 21, 2026.
The release gives no price. Commercialization and reimbursement sit with Abbott.
The verdict
The indicated population is the buyer: average-risk adults 45 and older who choose a blood-based screen and accept colonoscopy after a positive result. A buyer whose priority is finding advanced precancerous lesions has Freenome's own 13.7% sensitivity for them to weigh against 81.1% for colorectal cancer.
Editorial review last generated November 2, 2026. Synthesized from clinician sentiment, peer-reviewed coverage, and our editorial silo picks. Refined by hand where vendor facts change.
What it costs
All tiers are custom-quoted. The vendor does not publish per-provider list pricing.
| Tier | Monthly | Annual | Notes |
|---|---|---|---|
| Enterprise | Not stated | Not stated | No public price. |
Source: vendor pricing page. Last checked November 2, 2026.
Who builds it
Freenome (Freenome) was founded in 2014 in US, putting it 12 years into market.
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