Golden Helix is built for institutions that demand complete control over patient genomic data, with certifications, deployment flexibility, and audit trails to prove it.
Golden Helix maintains the certifications and regulatory marks that clinical laboratories require. Our quality management system governs every stage of software design, development, and delivery.
Certified quality management system for the design, development, and delivery of medical device software. Governs our entire software lifecycle from requirements through release.
VarSeq Dx is CE marked for in vitro diagnostic use in the European Economic Area. Installation verification and tiered proficiency are bundled and required before diagnostic use.
Field Application Scientists support transparent NGS workflow validation from sample prep through reporting. No black-box pipelines. You understand and control every step of your validated process.
Golden Helix develops two software products under one ISO 13485-certified medical device quality management system. VarSeq Suite is licensed for research use. VarSeq Dx is an in vitro diagnostic medical device CE-marked under Regulation (EU) 2017/746 (IVDR) for clinical diagnostic use.
Research applications in genomics: variant analysis, annotation, filtering, and reporting workflows that researchers and laboratories design, validate, and control themselves.
VarSeq Suite is labeled and intended for Research Use Only (RUO). It is not a medical device and has not been cleared, approved, certified, or registered by any regulatory authority for clinical diagnostic use. Golden Helix makes no representation that VarSeq Suite satisfies requirements applicable to medical devices, in vitro diagnostic products, or clinical laboratory regulations in any jurisdiction.
Worldwide, subject to applicable export controls.
Any laboratory-developed test (LDT), clinical workflow, or patient-related application developed or implemented using VarSeq Suite is independently designed, validated, and controlled solely by you. You are solely responsible for determining the suitability, performance, regulatory status, and compliance of any such use under applicable laws and regulations.
VarSeq Dx provides the most of the VarSeq Suite capabilities: variant annotation, filtering, ACMG/AMP classification, CNV and structural variant analysis, automation, and reporting.
Clinical diagnostic use as described in its applicable Instructions for Use (IFU). VarSeq Dx is intended for use by qualified laboratory professionals and is designed to support, not replace, professional medical judgment.
VarSeq Dx is an in vitro diagnostic medical device CE-marked under Regulation (EU) 2017/746 (IVDR).
VarSeq Dx is offered only in jurisdictions where Golden Helix has determined it is authorized for distribution as a medical device.
Before VarSeq Dx may be operated as a medical device, each deployment must complete:
Both are described in the applicable IFU and supported by Golden Helix Field Application Scientists.
| VarSeq Suite | VarSeq Dx | |
|---|---|---|
| Manufacturer | Golden Helix, Inc. | Golden Helix, Inc. |
| Manufacturing QMS | ISO 13485:2016 certified | ISO 13485:2016 certified |
| Regulatory status | Research Use Only. Not a medical device. | In vitro diagnostic medical device, CE marked under Regulation (EU) 2017/746 (IVDR) |
| Intended use | Research applications | Clinical diagnostic use per IFU |
| Geographic availability | Worldwide, subject to export controls | Authorized jurisdictions only |
| Required before clinical use | Not for clinical diagnostic use | IFU + Installation Verification Test (IVT) + User Proficiency Test (UPT) |
| Validation responsibility | Customer (LDT validation) | Qualified laboratory professionals, operating under applicable laws and accreditation |
Full intended use, regulatory status, and license terms are set forth in the applicable Instructions for Use and End User License Agreement.
Multi-tenant SaaS platforms inherit shared risk. Golden Helix puts the full software suite on your infrastructure, behind your firewall.
LDAP/Active Directory integration enforces role-based access to patient data. SSO via SAML means credentials are managed at the institutional level with your existing password policies.
Every user action within VarSeq and VSWarehouse is logged and attributed to authenticated individuals. Interpretations, classifications, and signed-out reports carry full user provenance.
In air-gapped and firewall-mirrored deployments, patient data never traverses the public internet. All outbound connections support authenticated proxy routing.
All analysis, interpretation, and reporting occurs within your institution's controlled environment. Workflow state saving ensures any past analysis can be reproduced exactly as it was run.
Clinical genomics operates at the intersection of the most sensitive data categories and the strictest regulatory frameworks. Golden Helix is architected to meet these requirements without forcing trade-offs.
Request security architecture details, certification documents, or a compliance review call.
With Golden Helix, there is no shared tenancy, no vendor-hosted patient data, and no dependency on external cloud services to run your clinical workflows.
As genomic testing expands internationally, labs face increasing requirements to keep data within jurisdictional boundaries. On-premises deployment eliminates cross-border transfer concerns entirely.
Air-gapped systems are immune to network-delivered encryption attacks. No internet connection means no remote attack vector.
On-premises deployment keeps patient data within your physical network boundary. No data traverses the public internet in any deployment tier.
Multi-tenant platforms expose you to your provider’s security posture. Self-managed deployment means your perimeter is yours to control.
Unlike compromised credentials, genomic data cannot be reissued. A breach of genetic information has permanent consequences for affected patients.
Active Directory, SAML, and LDAP integration. Credentials are managed at the institutional level. Passwords never leave your network. Complexity, rotation, and reuse policies follow your existing standards.
Logical data separation for multi-group and multi-site deployments. Each clinical team operates independently within their workspace while sharing institutional knowledge through controlled catalogs.
Centralized resource management and usage monitoring. Track active users, sample throughput, and storage consumption across your entire deployment from a single administrative interface.
Regulatory guidance, IVDR transition strategies, and best practices for validating clinical genomics workflows.
Join institutions worldwide that trust Golden Helix for secure, compliant clinical genomics infrastructure.