Diagnostics & Genomics
S

SOPHiA GENETICS

Cloud native genomics analysis company (NASDAQ: SOPH). The SOPHiA DDM platform applies machine learning with patented algorithms to call, annotate, and pre classify variants from next generation sequencing data, technology agnostic across sequencing instruments, with genomics, radiomics, and multimodal analytics modules. Deployed as software that hospitals and labs run themselves: at Mount Sinai, for example, SOPHiA provides the analytical software while the health system runs it as a laboratory developed test in its own CLIA certified, CAP accredited lab. The platform reports a network of more than 750 hospitals, academic centers, and labs and a federated learning model across participating institutions. Certain applications are research use only and regional clearance varies.

Last VerifiedJuly 12, 2026
Founded
2011
Headquarters
Boston, Massachusetts
Categories
diagnostics-and-genomics
Indexed Products
SOPHiA DDM Platform
Buyer Segments
Academic Medical Center, Large IDN, Pharma / Life Sciences
Assessment

Capability Axes

AI Capability
AI Centrality
A
Vendor Published

The product is the AI: SOPHiA DDM uses machine learning with patented algorithms to call, annotate, and pre classify genomic variants from raw sequencing data, distinguishing clinically relevant alterations from sequencing noise. Analysis is the deliverable.

Autonomy and Oversight Model
Not rated
Model and Technology Transparency
Not rated
Clinical and Operational Evidence
B
Vendor Published

Scale is well documented (reported 1.8 million plus genomic profiles analyzed, roughly 30,000 analyses per month, 750+ institutions). Analytical validation studies exist including a clinical trial assay validation with a research partner; independent performance figures per application were not compiled this pass.

AI Safety and PHI Stewardship
Not rated
Regulatory and Compliance
HIPAA and BAA Posture
Not rated
Security Certifications and Trust Center
Not rated
FDA and Regulatory Status
B
Vendor Published

Positioning is stated with appropriate care: the platform is IVDR certified for certain applications in the EU, while some applications are labeled Research Use Only and clearance varies by country. Deployments such as Mount Sinai run DDM as a laboratory developed test in the customer's own CLIA certified, CAP accredited lab, with SOPHiA providing software and not performing diagnostic testing. Graded on clarity of regulatory positioning, not on possession of a specific US clearance.

AI Governance and Bias Disclosure
Not rated
Integration and Deployment
EHR and Interoperability Depth
Not rated
Deployment Model and Data Residency
B
Vendor Published

Cloud native and decentralized by design, deployed into hospital and lab workflows across a reported 750+ institution network with a federated learning approach that keeps analysis distributed. Held back from A because specific data residency commitments by region were not retrieved.

Commercial
Commercial Transparency
Not Rated
Vendor Published

No public pricing. Contact the vendor. Enterprise and per analysis models are referenced in third party coverage but no rate card is published.

Setting and Specialty Coverage
Not rated
Public Record

Announced Deployments

Publicly announced health system deployments and partnerships. This is a record of announcements, not an assessment of deployment success or scale.

Mount Sinai Health System
SOPHiA DDM for cancer genomics variant analysis, run as an LDT in Mount Sinai's own lab
Commercial

Pricing

Vendor-published figures are labeled as such. Figures labeled “Estimated” are derived from third-party sources and have not been confirmed by the vendor.

Entry Price Pricing Basis BAA Tier Implementation Source
Contact the vendor
Enterprise and per analysis agreements for the DDM platform Third Party Estimated

Enterprise and per analysis models are referenced in third party coverage; SOPHiA is a public company (NASDAQ: SOPH) so aggregate economics appear in filings, but platform pricing is not published.

AI Health Index

An independent reference for evaluating AI vendors in healthcare. No vendor pays for inclusion, placement, or rating.

Index Status
Last index update
July 19, 2026
The AI Health Index is an editorial reference, not a regulatory body. Vendor data is verified against published sources and public regulatory filings. Figures labeled “Estimated” have not been confirmed by the vendor. See the Methodology page for evaluation standards and limitations.
© 2026 AI Health Index
3801 N Capital of Texas Hwy, Ste E240 · Austin, TX 78746