With our release of VarSeq 3.0.0, we’re excited to highlight one of the most impactful capabilities of our platform: Dx Mode. This program enables VarSeq to be used as a Class A Medical Device, supporting laboratories operating within the European In Vitro Diagnostic Regulation (IVDR). The use of Dx Mode is backed by Golden Helix’s ISO 13485-compliant quality management system.
What is Dx Mode?
This is more than just another module. This program was created to show that VarSeq has been successfully deployed and to ensure that your team knows how to use the software with confidence. We have addressed the complexity of using an NGS Tertiary Analysis Solution as a Class A Medical device for IVDR compliance by making this an FAS-led onboarding experience. With our renowned FAS Support Team, a lab can easily transition into IVDR compliance.
As precision medicine advances and regulations evolve, our mission remains the same: to empower labs with high-quality, rigorously validated software tools that support informed clinical decision-making.
Dx Mode in VarSeq 3.0.0 takes another major step forward in that commitment.
VarSeq as a Class A Medical Device
With Dx Mode enabled, VarSeq can be used as a Class A in vitro diagnostic medical device under IVDR. This designation represents the safest class of medical devices, which is appropriate for software that supports genomic interpretation workflows while maintaining strict quality, traceability, and validation standards. This means that the ‘Dx Mode’ Stamp will show that VarSeq 3.0.0 has undergone deployment validation (this indicates that VarSeq operates as expected), and that the team is using the software correctly. VarSeq 3.0.0 Dx Mode supports our customers with regulatory alignment, ensuring labs can confidently integrate VarSeq into their diagnostic pipelines.
How to Activate Dx Mode in VarSeq 3.0.0
Turning on Dx Mode in VarSeq ensures that your instance of the software is validated, documented, and ready for use in regulated environments. As mentioned above, to activate, labs must complete two key steps:
- Installation Verification: A short verification process confirms that VarSeq is correctly installed, configured, and fully operational in your local environment.
- User Certification: At least one member of your team must complete the Golden Helix User Certification Program, demonstrating their proficiency with VarSeq’s variant analysis tools. This will include hands-on training with an FAS, culminating in a short quiz to demonstrate that the user is correctly implementing the software.
Once these steps are completed, this program can be enabled and used on a per-version basis. Our users remain in control of when they update VarSeq and can re-validate with version upgrades as they choose.
Taking the Next Step
Overall, our customers love Dx Mode and the activation process. Our friendly FAS team makes onboarding approachable and accessible. As a bonus, certification ensures that your team works with confidence and consistency while running NGS tests. Most importantly, this program keeps a lab’s workflows aligned with IVDR expectations.
Whether your lab is preparing for IVDR compliance, serving international clients, or strengthening internal quality systems, Dx Mode offers a clear and supported pathway to confident clinical operation. Please reach out to [email protected] or your Area Director for more information.
