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Last updated: June 13, 2026
Back to directoryFreenome SimpleScreen CRC medical AI product profile
Blood-based colorectal cancer screening program built on Freenome's multiomics platform, which combines genomic, epigenomic, proteomic, computational-biology, and machine-learning signals.
Precision medicine and data
Best fit
Health systems evaluating whether an easier blood-draw screening option could improve average-risk CRC screening participation while preserving guideline-based follow-up and colonoscopy pathways.
- Primary use case
- AI-enabled multiomics colorectal cancer screening workflow using a standard blood draw, clinical-lab processing, and health-system screening program partnership
- Audience
- Health systems, screening program leaders, gastroenterology groups, oncology prevention teams, laboratory leaders, and population-health teams evaluating blood-based colorectal cancer screening access
- Risk level
- High
- Pricing signal
- Public pages invite health systems to apply for founding-partner early access and do not publish pricing; request current laboratory, partnership, payer, workflow, and patient billing terms.
- Official sources
- 5 official sources
Compare within workflow: Precision medicine and data · comparison shortlist · source index
Regulatory, privacy, evidence, and workflow lens
Product-specific review. These product-specific signals summarize what the cited sources imply before treating Freenome SimpleScreen CRC as safe for a local clinical, operational, or research workflow.
| Regulatory / FDA | Treat as a high-risk screening and laboratory workflow. Verify FDA clearance or approval status, CLIA and state laboratory requirements, local medical policy, and whether early-access or commercial use is permitted for the exact population and clinical pathway. |
|---|---|
| Privacy | Review clinical-trial, laboratory, patient, provider, research, commercial-relationship, genomic, proteomic, website, cookie, third-party service-provider, retention, de-identification, international-transfer, and security terms before sharing identifiable data. |
| Evidence | Use PREEMPT CRC and the JAMA publication as core diligence inputs, but evaluate sensitivity, specificity, advanced adenoma performance, population fit, follow-up adherence, comparison to existing screening methods, and real-world implementation outcomes locally. |
| Workflow | Best governed as a supervised screening-access program with primary care, GI, laboratory, oncology prevention, privacy, compliance, payer, scheduling, and navigation teams defining eligibility, ordering, result disclosure, colonoscopy follow-up, and monitoring. |
Where Freenome SimpleScreen CRC fits
Freenome describes SimpleScreen CRC as an early-access blood-based colorectal cancer screening test developed from its multiomics platform. Its science and PREEMPT CRC pages describe computational biology, machine learning, genomic, epigenomic, and proteomic signals, a prospective multi-center study in average-risk screening participants, and a JAMA-published validation dataset. Freenome's health-system page states SimpleScreen CRC has not been FDA cleared or approved and that Freenome's clinical laboratory is CLIA-certified for high-complexity testing. Its privacy notice describes personal information collected from website visitors, clinical-trial participants, health care providers, research collaborators, and commercial partners, along with security, retention, sharing, and de-identification practices.
Not for: Replacing diagnostic colonoscopy, screening high-risk patients outside stated study criteria, autonomous cancer diagnosis, or clinical deployment without regulatory, laboratory, privacy, payer, and follow-up governance.
What to verify before using Freenome SimpleScreen CRC
- Current FDA, CLIA, state laboratory, payer, guideline, and local medical-policy status for SimpleScreen CRC at the time of ordering.
- Whether the intended population matches average-risk adults studied in PREEMPT CRC, including age, exclusion criteria, screening interval, and follow-up colonoscopy workflow.
- How blood samples, genomic, epigenomic, proteomic, clinical-trial, patient, provider, and commercial-relationship data are collected, retained, de-identified, shared, secured, and governed.
- How positive, negative, invalid, delayed, or discordant results are communicated to patients and clinicians, routed for colonoscopy, documented, and monitored for equity and adherence.
- Local validation plan for screening uptake, sensitivity, specificity, advanced adenoma detection limits, follow-up completion, false reassurance, access, patient experience, and downstream capacity.
Source links
Use these links to confirm current claims, terms, regulatory status, pricing, and deployment requirements.
- www.freenome.com / our-company / health-systems
- www.freenome.com / our-science
- www.freenome.com / clinical-expertise / the-preempt-crc-study
- www.freenome.com / privacy-policy
- www.freenome.com / newsroom / freenome-announces-expanded-artificial-intelligence-and-deep-learning-initiatives-accelerated-by-nvidia-to-advance-personalized-multi-cancer-detection
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