// Trust & Security Report
Freenome Holdings, Inc.
Blood-based multiomics cancer screening platform using AI/ML for early detection; includes SimpleScreen CRC (colorectal), PREEMPT CRC (prospective study), and PROACT LUNG (lung cancer study) with clinical-grade testing via CLIA-certified laboratory.
Certifications held
2
Maturity
Growth
Trains on your data
Unknown
Trust center
No
// Certification ledger
Each held certification is backed by a verbatim quote from the vendor's own trust or security page. “Not confirmed” means we could not verify it publicly, not that the vendor lacks it.
Verify on freenome.com“Freenome's Clinical Laboratory is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) as qualified to perform high complexity clinical testing.”
Verify on freenome.com“We comply with the EU-U.S. Data Privacy Framework ("EU-U.S. DPF"), the UK Extension to the EU-U.S. DPF, and the Swiss-U.S. Data Privacy Framework. We have certified to the U.S. Department of Commerce that we adhere to the DPF Frameworks.”
> Show 5 unconfirmed / not-held certifications
source: freenome.comSimpleScreen CRC has not been cleared or approved by the U.S. Food and Drug Administration (FDA).
No public evidence of SOC 2 certification; no trust center or security page published.
No public evidence of ISO 27001 certification; not mentioned in privacy policy or public materials.
No public claim of HIPAA compliance in privacy policy, terms of use, or public materials despite handling Protected Health Information (PHI). HIPAA status unresolved—company may be HIPAA-covered or may operate as business associate under BAA, but this is not documented publicly.
No public evidence; company uses AI/ML as core technology but makes no public claims regarding AI governance certifications.
// Privacy & AI training
Trains on customer data
Not stated
Data processing agreement
Not offered
Data region
United States (on-premises servers); international transfers via standard contractual clauses or adequacy decisions
No explicit mention in privacy policy of AI/ML training on collected personal or clinical data. The platform uses AI/ML for cancer detection analysis, but customer data training practices are not disclosed.
// Security controls
Encryption in transit and at rest
Encryption mentioned in privacy policy; specific protocols (TLS, AES) not detailed.
freenome.comAccess controls and authentication
User access and authentication controls, data integrity controls mentioned.
freenome.comContinuous monitoring and logging
Continuous security monitoring and event logging stated.
freenome.comPhysical and organizational safeguards
Physical, organizational, administrative, and technical measures noted; details not published.
freenome.comPenetration testing, vulnerability management
No public information available; not mentioned in published materials.
Incident response and breach notification
No details published in privacy policy or public materials.
// Products & data scope
data: Patient blood sample data, multiomics biomarkers, clinical history; handles Protected Health Information (PHI)
Blood-based colorectal cancer screening test; FDA PMA submitted August 2025, expected approval mid-2026. Clinical validation: 85% CRC sensitivity, 22% APL sensitivity at 90% specificity. Partner: Exact Sciences (Abbott) for commercialization.
data: 40,000+ trial participants; full clinical and genomic data collection for validation and research
Largest prospective colorectal cancer screening study; generates clinical evidence for SimpleScreen platform validation and FDA submissions.
data: Up to 20,000 geographically and demographically representative participants; lung cancer screening data
Ongoing lung cancer early detection study; recruitment and validation phase.
// What to watch
- HIPAA compliance status unresolved: Company handles Protected Health Information (PHI) through clinical trials and patient testing, yet makes no public claim of HIPAA compliance. No mention in privacy policy, terms, or public materials. Unclear whether company is HIPAA-covered, operates under BAA agreements, or does not consider itself subject to HIPAA.
- No published trust center: /security page returns 404; no dedicated security/compliance documentation published.
- Missing standard SaaS security certifications: No public SOC 2 Type 1/II, ISO 27001, or ISO/IEC 42001 certifications despite using AI/ML as core technology.
- Vendor type mismatch: Freenome is a clinical biotech/diagnostics company, not an AI SaaS platform. Primary products are FDA-regulated medical devices (pending approval) and clinical studies, not software tools for purchase. Question whether this vendor is appropriate for AIFoxx's AI tools directory.
- FDA approval pending: SimpleScreen CRC not yet FDA-cleared/approved (expected mid-2026); regulatory status ongoing.
- AI/ML training disclosure gap: Privacy policy does not disclose whether customer/patient data is used to train the AI/ML models. This is material for biotech companies.
- Over-claim potential: Marketing positions platform as AI-driven cancer detection, but specific AI governance and testing standards are not publicly documented.
// At a glance
Pricing model
Not disclosed publicly; clinical laboratory service model (likely test-per-order with insurance/patient reimbursement)
Self-hostable
No
// How we verified this
Every certification marked HELD is confirmed against a verbatim quote on Freenome Holdings, Inc.'s own trust, security, or privacy pages. We reject certifications claimed only on third-party aggregators, on a cloud host's behalf, or by a similarly named company.
Last verified 2026-07-07. Compliance changes over time. Always confirm directly with the vendor before relying on any certification for a purchasing or compliance decision.
freenome.com