Get ready for the future with regulatory compliant variant interpretation

Welcome to another novel blog post!

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Author: Dolores Salvado

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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.

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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. 

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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.

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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:

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1. Laboratories may be forced to use commercial IVD devices instead of in-house developed tests, when available.
2. Laboratories have to apply the same standards and substantially the same efforts to the development of in-house developed tests very much like regular IVD manufacturers.
3. Regulations apply to software as well, e. g. open source software that is used in several institutions may be an IVD device in its own right.

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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. 

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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! 

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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).

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But what will it mean to Nostos Genomics and our AION platform?

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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. 

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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:

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• ‍A CE-marked in vitro diagnostic medical device (CE-IVD) ‍
• Manufactured in compliance with the effective principles of quality management for medical devices (ISO 13485:2016)
• Compliant with the EU's General Data Protection Regulation (GDPR). 
• Data security guaranteed by the AION platform hosted on ISO 27001 (HDS) compliant infrastructure

And…..

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• Soon to be IVDR certified (something which we are extremely proud of)

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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.

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If you’re interested in finding out more, get in touch today to speak to one of our experts and book a demo!

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For more information about AION, visit https://www.nostos-genomics.com/solutions

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References:

1. Ben Liesfeld, ‘The IVDR affects how genetic testing laboratories can operate all over Europe’, Limbus News, Medium, 2020, https://blog.limbus-medtec.com/the-ivdr-affects-how-genetic-testing-laboratories-can-operate-all-over-europe-c39749e8ef07
2. Johner Institute, 2018, In-vitro Diagnostic Device Regulation IVDR, https://www.johner-institute.com/articles/regulatory-affairs/ivd-regulation-ivdr/
3. DNV GL, Group Technology and Research (GTR), Precision Medicine Program, Clinical Decision Support Software Regulatory landscape in Europe from May 26th 2020, https://bigmed.no/assets/Reports/clinical_decision_support_software.pdf

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