This last Wednesday we introduced VarSeq Dx Mode which enables customers to use VarSeq as a CE marked in vitro diagnostic medical device! If you missed our live webcast, no problem! You can watch the recording here.
In brief, we started out discussing IVDR and that it establishes standardization for medical devices and their manufacturers that market and sell these devices or products in the European Union. IVDR is replacing previous directives (IVDD, MDD, and AIMDD) primarily to improve post market surveillance which assess the safety and reliability of devices after they have been in the introduced to the market. Devices that are currently CE marked under these previous directives are in an active transition period and must switch to IVDR as early as 2027. In addition, until these devices transition to IVDR, they have to maintain their IVDD certification and they can only make minor changes to the products and cannot introduce new features to the product.
Next we discussed the role of ISO13485 with the new IVD regulation. Many labs currently have quality management systems that comply with ISO 15189, which is actually a requirement stated by IVDR. However, the IVD regulations also clarify that ISO 15189 compliant quality management systems are not sufficient for manufacturing lab developed tests and it is expected for these labs to update or augment their current quality management systems to comply with ISO 13485. This whole process becomes easier for labs when the lab developed tests are built by integrating IVDR compliant devices with ISO 13485 certified manufactures.
Golden Helix has been an ISO 134585 certified manufacturer since January of this year and VarSeq is a CE marked IVD under IVDR as of this April! Just this week we released VarSeq 2.6.1 which offers the use of VarSeq as a medical device via Dx mode. To use VarSeq in Dx mode there are a couple of requirements:
- To complete an installation verification test to ensure VarSeq is installed correctly and functioning optimally in the user’s environment.
- Complete the Golden Helix User Certification Program to confirm that at least one lab member has the knowledge and understanding of VarSeq to conduct variant analysis within the software.
There were also some really good questions that you all asked and you find these questions with their answers below:
Q1. Is the customer certification program required?
Yes, from the regulatory perspective auditors need confirmation that VarSeq is installed correctly and functioning proficiently in our users environments and confirmation that our users have sufficient understanding and knowledge of the VarSeq software and how to conduct analysis within it. We expect that this process for existing customers is straight forward to obtain but there is an expected learning curve for new customers to get up to speed.
Q2. What does the certification process entail?
We touched on this a bit during the presentation but there is a tiered approach to certification depending on which features are activated on the license. Essentially our field application scientist team will take you through certification process individually. But the certification covers a variety of knowledge factors and practical factors for VarSeq usage and variant analysis within VarSeq. The certification will end with a quiz and short FAS practical and both are required to pass. But then Dx mode can be enabled once this process is completed.
Q3. Does everyone in the lab need to obtain the certification?
No, minimally only one person needs to be certified to use VarSeq to activate Dx Mode for the lab. However, we plan to work with your certification needs as a lab so this could mean doing a classroom style approach if multiple VarSeq users need to be certified and actually we recommended in particular for larger labs to have additional people certified.
Q4. How long is Dx Mode active?
Dx mode is validated on a per VarSeq version basis. For instance, if you activate Dx Mode for VarSeq 2.6.1, then we release a VarSeq 2.7.0 version, Dx Mode will remain validated for 2.6.1, but if you wish to upgrade VarSeq and to use Dx Mode for 2.7.0, the validation process has to happen again to validate dx mode for VarSeq 2.7.0. Previously validated versions can still be used in Dx Mode, so if you upgrade to VarSeq 2.7.0 and have not yet validated 2.7.0 for Dx Mode, 2.6.1 could still be used in Dx Mode since it had already been validated.
Q5. Does this apply outside of Europe?
Yes, anyone can obtain Dx Mode. This is especially relevant for labs that process samples from European countries even if the lab itself is not physically headquartered in a European country. In addition, some other countries or regions follow European regulatory best practices, so Dx Mode would be interesting or applicable to these labs too.
Q6. Are there additional expenses?
Yes, there are additional expenses but as Casey discussed we now have some very attractive bundles to offer as part of the introduction of Dx Mode. But in general this is a great topic to discuss with area directors.