Welcome to another novel blog post!
Author: Dolores Salvado
Regulatory compliance isn't always the most interesting or exciting subject matter to engage an audience on, but at Nostos it's something we take very seriously. We think it's important, not only to ensure we provide our customers with confidence and peace of mind that they are using a solution that is compliant to the highest regulatory standards for medical in vitro diagnostics devices. But most importantly, to ensure our users and ultimately their patients, get the best information to drive diagnosis and clinical outcomes.
Around 18 months ago (in May 2022), the IVDR 746/2017 (In Vitro Devices Regulation) entered into force. As you may well be aware, IVDR represents a much more rigorous regulatory framework with many more requirements to ensure higher quality and optimum performance of the device - as well as guarantee its safety to the end user.
Changes to the regulation clearly provide many benefits: 1) To the patient - who will receive more accurate diagnosis, as the new legislation now requires clinical benefits to be demonstrated 2) To the laboratory - who will now be able to provide devices which have been tested to a higher standard, and 3) To the IVD manufacturer - who (in the case of Nostos) welcomes the exciting new challenge to improve the quality of our AION platform even further.
However, with that said, we are well aware that for many of our customers - that work in genetic testing laboratories - it may well create more of a headache to them for a number of reasons1:
So, the need for health institutions and genetic testing laboratories to ultimately comply with the regulations, or use commercial IVD devices, could potentially be an up-hill struggle. Having gone through this transition at Nostos, we are all too familiar with the many hoops you need to jump through to achieve the IVDR certification.
We worked quickly towards meeting the requirements of the new regulation and set to work thinking about what we would need to do to become a first in class IVDR compliant variant interpretation platform!
For us, this involved setting up a QMS designed on risk-based approaches, guaranteed clinical performance validation procedures, as well as continuous post-market surveillance evaluation. Not to mention undergoing a strict conformance assessment by one of the few IVDR notified bodies in the EU.
With compliance in mind, our aim is always to provide our users with our technical expertise on clinical performance and safety, according to the state-of-art AI-driven clinical decision support-IVD. Whilst ensuring our customers also become compliant to IVDR and support their regulatory compliant processes (either as In-house IVD manufacturer: IVDR, ISO 13485:2016; or as a clinical diagnostics provider ISO 15189:2022).
But what will it mean to Nostos Genomics and our AION platform?
Our mission is all about providing our users and ultimately their patients - people with a genetic disease - the information they need to make informed health decisions. That means we need to be able to provide a clinically validated platform that not only enhances laboratory efficiencies with quicker diagnosis and higher diagnostic yields, but also complies with the highest possible quality and regulatory standards across the EU - improving the effectiveness of genetic testing laboratories.
To achieve this, we keep compliance at the top of the agenda, we keep it top of mind and at the heart of everything we do - As a result our AION platform is:
All of which is enabling labs to take advantage of the growing demand for genetic testing and scale accordingly, as we increase the interpretation throughput for each analyst on staff - empowering people living with genetic diseases to start a new journey.
If you’re interested in finding out more, get in touch today to speak to one of our experts and book a demo!
For more information about AION, visit https://www.nostos-genomics.com/solutions