Latest news with #IVDR
Business News Wales
5 days ago
- Health
- Business News Wales
Llusern Scientific Speeding Up Infection Diagnosis with Welsh Innovation Support
Llusern Scientific is developing rapid diagnostic tests to transform how urinary tract infections are diagnosed and treated. With targeted support from the Welsh Government's Innovation team, the company, which is based at Cardiff Edge Business Park, is bringing its first product to market. It is set to pave the way for faster diagnosis, better patient outcomes and reduced antibiotic misuse. Established in 2020 as a spin-out from the University of South Wales, the company set out to address a major health challenge. Urinary infections affect more than 100 million people worldwide each year. Its portable, easy-to-use molecular diagnostic device delivers accurate results within 35 minutes, giving clinicians fast and reliable information. The company has now announced that it has been awarded ISO 13485 certification for its Lodestar DX testing system, a rapid molecular diagnostic platform for urinary tract infections (UTIs). Dr Emma Hayhurst, co-founder and CEO of Llusern Scientific, said: 'When we founded Llusern Scientific, we were on a mission to make a positive difference in healthcare by developing a point-of-care diagnostic that would enable us to improve antimicrobial stewardship. Achieving ISO 13485 certification is a major milestone in our mission because it demonstrates that we have built a manufacturing facility to world-class standards. 'Not only does our Lodestar UTI testing system help a clinician decide whether or not to prescribe an antibiotic, but it will also identify the bacterial cause of the UTI. This enables clinicians to quickly target the right bug with the right treatment to save lives. Now we have ISO 13485 certification, our next goal is to achieve IVDR certification to further expand the market potential for our innovative molecular diagnostic globally.' There are more than 400 million UTI cases globally each year, of which around 90% are women. According to the Sepsis Trust approximately 15-30% of sepsis cases are caused by a UTI. Research has shown that antibiotics are overprescribed by as much as two times for UTIs leading to them being a major driver of antimicrobial resistance (AMR). As well as providing guidance on the best treatment option, Lodestar DX also provides a clear 'rule-out' decision where antibiotics are not necessary, helping to reduce AMR through antibiotic stewardship. ISO 13485 certification is a crucial regulatory step for marketing medical devices globally, as it demonstrates that a manufacturer has a robust Quality Management System in place, showing commitment to patient safety, regulatory compliance, and consistent product quality. Llusern is preparing for commercial launches across India and the Middle East and North Africa region this year, and the US in 2026. The company has received a range of targeted support from the Welsh Government's Innovation team, including SMART Flexible Innovation Support (SFIS), expert design assistance and intellectual property (IP) strategy development—each playing a vital role in advancing the technology and preparing for commercial scale-up. Initial SFIS support in early 2024 enabled the team to develop a clear innovation plan, setting out priorities for product improvements, new clinical applications and growth. A second SFIS award in September 2024 has since supported the delivery of this plan, while design and IP interventions have strengthened its route to market. As a result, Welsh Government innovation support has helped Llusern Scientific to: Enhance its existing diagnostic platform, making it suitable for use in a wider range of clinical settings. Develop a new unique test panel design, addressing contamination risks and improving ease of use for non-laboratory settings. Strengthen its IP portfolio through a comprehensive audit and actionable recommendations, boosting investor confidence. Expand research and development facilities at Cardiff Edge Business Park. Advance collaborations with Public Health Wales and NHS partners, supporting clinical validation and real-world evidence generation. While Agile Cymru funding has provided valuable opportunities to explore international markets, the company's core innovation progress has been driven by targeted support from the Welsh Government's Innovation team.
Yahoo
04-06-2025
- Business
- Yahoo
Introduction to the In-Vitro Diagnostic Regulation (IVDR): Online Training Course with Practical Workshops (July 16-17, 2025) Led by Stuart Angell (Director, IVDeology Ltd.)
Dublin, June 04, 2025 (GLOBE NEWSWIRE) -- The "Introduction to the In-Vitro Diagnostic Regulation (IVDR) Training Course" has been added to offering. The In-Vitro Diagnostic Regulation (EU) 2017/746, which came into force in May 2017 with a transition period of five years, is intended to strengthen the current approval system for in-vitro diagnostics and makes substantial changes to the existing IVD Directive (98/79/EC) legislation. The regulation introduces a new risk-rule classification system based on the Global Harmonization Task Force (GHTF) rules which, for the first time, takes patient impact into consideration. This will have a significant impact on all manufacturers of IVDs as about 80 per cent of all devices will now require some form of conformity assessment by a Notified Body. This seminar will clarify the requirements applicable to in-vitro diagnostic devices under the new regulation, highlight the major changes to responsibility and product data expectations and provide a thorough understanding of the impact on the industry. Practical workshops over the two days will help consolidate the information provided. Certifications CPD: 12 hours for your records Certificate of completion Who Should Attend? Regulatory affairs personnel Persons responsible for regulatory compliance Quality assurance professionals Those responsible for OEM/subcontractor control of IVDs Economic operators, importers, distributors Agenda Day 1 Introduction to IVDs Definition of an IVD Why are IVDs regulated separately? Investigating standards and their use Exploring CE marking Historical overview of the current IVD Directive (98/79/EC) Examining the structure and content of the IVD Directive Introduction to IVD Regulation (EU) 2017/746 How did we come from the Directive to the Regulation? Main drivers for change Scale of change Structure and Annex Notified Bodies How has the role of the Notified Bodies changed under the IVD Regulation? Conformity assessment IVD Regulation - key changes Persons responsible for regulatory compliance Economic operators, importers, distributors UDI Software Intended use/intended purpose (including an interactive workshop) Performance evaluation Clinical evidence Compiling the technical documentation for an IVD Structure and content of STED Technical file vs design dossier Labelling requirements and strategies Understanding electronic instructions for use (e-IFUs) Use of language and symbols Translation requirements Traceability and EUDAMED UDIs Day 2 ISO 13485:2016 Introduction to ISO 13485 Key changes from 2012 to 2016 Where does it fit with IVDD & IVDR? Risk-based classification How are IVDs classified? Workshop: Product classification Discussion on the classification of example IVDs Risk management Regulatory requirements ISO14971 Usability Workshop: Risk management Clinical evidence and common specifications Scientific validity vs performance evaluation Vigilance and PMS Regulatory requirements Incident reporting/FSCA management Case studies: Reporting/recalls PMS Key timelines and practical considerations Discussion: Preparing a roadmap for transition SpeakerStuart Angell Director, IVDeology Angell, This MDTI expert is a joint director in his own consultancy specialising in global regulatory affairs strategy and compliance for in vitro diagnostics and medical devices focusing on the transition to the new IVD/Medical Device Regulations, MDSAP and ISO13485:2016. He has over 15 years in the IVD industry and in previous roles has been responsible for designing, reviewing and maintaining regulatory frameworks for self-declared and annex list II products including technical documentation for EU and global submissions (FDA, Health Canada, TGA, Russia, Latin America). He has an excellent understanding of risk management, Post Market Surveillance (PMS) and more information about this training visit About is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. CONTACT: CONTACT: Laura Wood,Senior Press Manager press@ For E.S.T Office Hours Call 1-917-300-0470 For U.S./ CAN Toll Free Call 1-800-526-8630 For GMT Office Hours Call +353-1-416-8900Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
02-06-2025
- Business
- Yahoo
Press Release Biocartis NV: Biocartis Announces IVDR Class C CDx Certification of the Idylla™ EGFR Mutation Test
PRESS RELEASE 02/06/2025, 10:00 CEST Biocartis Announces IVDR Class C CDx Certification of the Idylla™ EGFR Mutation Test Mechelen, Belgium, 02 June 2025 – Biocartis NV ('Biocartis'), an innovative molecular diagnostics company, is pleased to announce that its Idylla™ EGFR Mutation Test has received the European Union (EU) Technical Documentation Assessment and Quality Management System certificate under the European In Vitro Diagnostic Medical Device Regulation (EU) 2017/746 (IVDR), making it the first Idylla™ Test to be certified as a Class C Companion Diagnostic (CDx) IVD Medical Device under the IVDR framework. The IVDR-certified Idylla™ EGFR Mutation Test is designed to serve as a CDx for the detection of EGFR exon 19 deletions and the L858R mutation, which are key biomarkers that guide targeted therapies for patients with non-small cell lung cancer (NSCLC). The IVDR certification confirms the Test's compliance with Europe's rigorous new regulatory standards, ensuring enhanced patient safety, improved information transparency, and robust data traceability. Designed for use on the Idylla™ Platform, the Test qualitatively detects 44 mutations across exons 18, 19, 20, and 21 of the EGFR gene – all within a single cartridge. Among these, exon 19 deletions and L858R mutations are validated as CDx targets, and the remaining mutations have been analytically validated. Utilizing formalin-fixed, paraffin-embedded (FFPE) tissue samples, the Test is fully automated from sample to result, delivering fast results in under 3 hours – streamlining laboratory workflows and empowering oncologists with timely treatment decisions for their patients. With 99.2% sensitivity (PPA) and 99.0% specificity (NPA) for the CDx targets, the Idylla™ EGFR Mutation Test ensures accurate detection of key EGFR mutations, providing healthcare professionals with actionable results to guide treatment decisions in NSCLC. For more information about the Test, please visit the Biocartis website or contact the Biocartis team. While the IVDR-certified Idylla™ EGFR Mutation Test is now available to customers across Europe, with availability in other non-US markets expected to follow progressively – Biocartis is also developing the Idylla™ EGFR CDx Test in the US with AstraZeneca. Upon approval, the Test will be intended to help identify patients with NSCLC who may respond to treatment with Tagrisso® (Osimertinib), AstraZeneca's third-generation EGFR-TKI treatment. Roger Moody, Chief Executive Officer of Biocartis, commented: 'Achieving IVDR certification for our Idylla™ EGFR Mutation Test is a key milestone for Biocartis and reinforces our commitment to quality and regulatory excellence. This is the first Idylla™ Test to be certified under the new IVDR framework, and we are currently pursuing certification of additional Tests in our portfolio. The IVDR establishes more rigorous standards to improve patient safety and diagnostic accuracy, and we are proud to be at the forefront of this evolution in European diagnostics.' ----- END ----- More information: info@ Biocartis NV. Generaal De Wittelaan 11B, 2800 Mechelen, Belgium About Biocartis With its revolutionary and proprietary Idylla™ Platform, Biocartis aspires to enable personalized medicine for patients around the world through universal access to molecular testing, by making molecular testing actionable, easy, fast and suitable for any lab. The Idylla™ Platform is a fully automated sample-to-result, real-time PCR (Polymerase Chain Reaction) based system designed to offer in-house molecular biomarker testing in only 3 hours, allowing fast and optimal treatment selection. Idylla™'s continuously expanding menu of molecular diagnostic tests and research assays addresses key unmet clinical needs. Today, Biocartis offers tests supporting lung, skin, thyroid, colorectal, endometrial, blood, brain and breast cancer. More information: Follow us on LinkedIn, Facebook and X (Twitter). Disclaimers Idylla™ Platform is CE-marked in Europe in compliance with EU IVD Regulation 2017/746, listed as a class II device in the US under establishment registration 3009972873, and registered in many other countries. Idylla™ EGFR Mutation Test (A0270/6) is CE-marked in Europe in compliance with the EU IVD Regulation 2017/746 (IVDR). Biocartis and Idylla™ are registered trademarks in Europe, the US and many other countries. The Biocartis and Idylla™ trademarks and logos are used trademarks owned by Biocartis NV. © June 2025, Biocartis NV. All rights lors de la récupération des données Connectez-vous pour accéder à votre portefeuille Erreur lors de la récupération des données Erreur lors de la récupération des données Erreur lors de la récupération des données Erreur lors de la récupération des données
Business Wire
29-05-2025
- Business
- Business Wire
Diagnostics.ai Launches Industry's First CE-IVDR Certified Transparent AI Platform for Molecular Diagnostics as Regulatory Deadlines take Effect
LONDON--(BUSINESS WIRE)-- Revolutionary Platform Sets New Benchmark for Transparency and Compliance in Diagnostic AI First-of-its-kind platform for molecular diagnostics shows exactly how AI-generated PCR result analyses are achieved - delivering transparency, trust, and CE-IVDR compliance. As the May 26th CE-IVDR compliance deadline comes into effect, launches the industry's first fully-transparent machine learning platform for clinical real-time PCR diagnostics – demonstrating exactly how each result was achieved, a first for molecular-testing machine learning. The technology is backed by over 15 years of experience and millions of successfully processed samples with >99.9% proven accuracy. The CE-IVDR Strategic Advantage Platform is response to the new wave of stringent EU regulations under the In Vitro Diagnostic Medical Devices Regulation (IVDR), which demand heightened standards for diagnostic accuracy, reproducibility, and algorithm transparency. 'While most diagnostic algorithms remain an impenetrable 'black box,' the API was engineered with transparency included from the ground up,' said Aron Cohen, Chief Executive Officer of 'Our platform delivers transparency and traceability that meet and support the highest standards set by CE-IVDR, making the AI decision-making process visible, understandable, and traceable.' Key Innovations of the Transparent AI Architecture platform is built around a pioneering 'model-aware' architecture, enabling laboratories to understand the suggestions that the AI makes. Highlighted Benefits: Transparent Result Attribution Directly shows how and why a result was achieved, eliminating reliance on post-hoc interpretations. Real-Time Model Monitoring Allows laboratories to track model performance and detect drift in real time – meeting IVDR Article 72 requirements. Per-Test Algorithm Accountability Easy to understand per test reports, ensuring comprehensive auditability. Clinician-Ready Explanation Generation Provides laboratory professionals and clinicians with clear, auditable explanations of diagnostic outcomes, supporting informed clinical communication. 'Our platform bridges the gap between compliance necessity and clinical confidence,' said Dr. Brian Glenville MD, Chairman of 'Laboratory directors can now explain to regulators, clinicians, and patients exactly how each diagnostic result was determined, creating a new level of trust in molecular diagnostics.' Now Available Across Europe The CE-IVDR Strategic Advantage Platform - including the CE-IVDR and MHRA registered AI API, as well as technical, regulatory and implementation support - is now available across Europe for both clinical laboratories and diagnostic manufacturers, empowering them to meet and exceed regulatory obligations while achieving deeper confidence in diagnostic results. Already in successful use in the U.S., U.K., and other countries, is trusted by leading laboratories for its reliable and transparent diagnostic performance. About is an established leader in AI-powered PCR analysis with over 15 years of experience serving clinical laboratories worldwide. The company has processed millions of samples with documented >99.9% accuracy and maintains full CE-IVDR and MHRA compliance. transparent machine learning platform transforms laboratory efficiency while enabling regulatory compliance.
The Wire
09-05-2025
- Business
- The Wire
DNV recognized as a Notified Body for Certification under In Vitro Diagnostic Regulation (IVDR)
OSLO, Norway, May 8, 2025 /PRNewswire/ — DNV, the independent assurance and risk management provider, has been recognized by the European Commission as a notified body for the certification of devices under the European Union's In Vitro Diagnostic Regulation (IVDR). The designation increases capacity for certifying in vitro diagnostic devices and providing access to the … Continue reading "DNV recognized as a Notified Body for Certification under In Vitro Diagnostic Regulation (IVDR)"
