Latest news with #IVDR
Business Upturn
11 hours ago
- Health
- Business Upturn
Roche receives CE Mark for minimally invasive blood test to help rule out Alzheimer's disease
Elecsys pTau181 is the first In Vitro Diagnostic Regulation (IVDR) certified test to rule out Alzheimer's associated amyloid pathology. The minimally invasive, blood-based test can serve as a rule out for Alzheimer's pathology, reducing the need for confirmatory testing with a negative result. Data from clinical study supports use in primary care for people with varying signs of cognitive decline. Basel, 23 July 2025 – Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today it has received CE Mark for its Elecsys® pTau181 test to measure phosphorylated Tau (pTau) 181 protein which is an indicator of amyloid pathology, a hallmark of Alzheimer's disease. The test, which has been developed in collaboration with Eli Lilly and Company, can be used by clinicians in conjunction with other clinical information to rule out Alzheimer's disease as the cause of cognitive decline. This could avoid the need for further confirmatory investigation for patients testing negative. 'The burden of Alzheimer's disease on society and healthcare systems is increasing as the world's population ages,' said Matt Sause, CEO of Roche Diagnostics. 'With Elecsys pTau181, doctors can give patients and their caregivers the clarity they need when establishing the cause of cognitive decline. By enabling an earlier and less invasive diagnosis, this test has the potential to improve patient outcomes and decrease costs for healthcare systems worldwide.' Barriers to early and accurate diagnosis of Alzheimer's disease exist across the world. Up to 75% of people living with symptoms are not diagnosed, and those who have received a diagnosis waited nearly three years on average after symptom onset.1 The identification of amyloid pathology is critical for Alzheimer's diagnosis and treatment. Current methods to confirm amyloid pathology – including positron emission tomography (PET) and cerebrospinal fluid (CSF) assessment – can be expensive, difficult to access and invasive. With a negative Elecsys pTau181 blood test, people can avoid further unnecessary investigations for Alzheimer's using CSF or PET and can identify the care pathway that is right for them. Clinical study results support that the test can be implemented effectively across care settings, including primary care, where most patients first seek help for cognitive concerns. Those with positive results are then able to undergo further testing, supporting earlier identification of Alzheimer's pathology. This is key to accessing new treatments that are most effective when used early in the disease progression, enabling patients to make informed decisions about their future care. Clinical data support the Elecsys pTau181 test for varying signs of cognitive decline The CE Mark for the Elecsys pTau181 blood test was based on data from a prospective, multicentre study, which included 787 patients across the US, Europe and Australia. The study showed the test was able to rule out Alzheimer's disease with a high negative predictive value (NPV) of 93.8% based on a 22.5% prevalence of amyloid positivity according to positron emission tomography (PET) scans, with 83.6% sensitivity. The rule out performance of the test was only minimally impacted by the patients' age, gender, body mass index or impaired kidney function. This global, prospectively-collected, diagnostic registrational clinical study was the first of its kind in the industry to investigate the test's clinical performance in a diverse patient population, aged 55-80 years old that reflects as closely as possible the patients who could benefit from the test. It involved a subset of patients from a wider study looking at a highly diverse set of patients with broad inclusion criteria, to ensure the test could be used effectively across different geographies and ethnicities. Elecsys pTau217 blood test Roche is also developing the Elecsys pTau217 blood test, an in-vitro diagnostic immunoassay for the quantitative determination of the protein Phospho-Tau (217P) in human plasma for use as an aid in identifying amyloid pathology. Recent data presented on Elecsys pTau217 showed that it was able to accurately detect amyloid pathology and was more stable than a pTau217/Aβ42 ratio in blood and plasma samples at room and refrigerator temperatures. Together with the high throughput and full automation of the assay, these data support the potential of Elecsys pTau217 as an accurate standalone test that could be scaled up for broad implementation in routine clinical practice worldwide across Roche's unmatched installed base. About Roche in Alzheimer's With more than two decades of scientific research in Alzheimer's disease, Roche is working towards a day when we can detect and treat the disease early, in order to stop or even prevent its progression to preserve what makes people who they are. Today, the company's Alzheimer's disease portfolio spans investigational medicines for different targets, types and stages of the disease, including trontinemab. On the diagnostics side, it also includes approved and investigational tools, including digital, blood-based tests and CSF assays, aiming to more effectively detect, diagnose and monitor the disease. Yet the global challenges of Alzheimer's disease go well beyond the capabilities of science, and making a meaningful impact requires collaboration both within the Alzheimer's community and outside of healthcare. Roche will continue to work together with numerous partners with the hope to transform millions of lives. About Roche Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world's largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice. For over 125 years, sustainability has been an integral part of Roche's business. As a science-driven company, our greatest contribution to society is developing innovative medicines and diagnostics that help people live healthier lives. Roche is committed to the Science Based Targets initiative and the Sustainable Markets Initiative to achieve net zero by 2045. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit . All trademarks used or mentioned in this release are protected by law. References [1] Alzheimer's Disease International. World Alzheimer Report 2022 [Internet; cited April 2025]. Available from: . Last accessed: April 2025 Roche Global Media Relations Phone: +41 61 688 8888 / e-mail: [email protected] Hans Trees, PhD Phone: +41 79 407 72 58 Sileia Urech Phone: +41 79 935 81 48 Nathalie Altermatt Phone: +41 79 771 05 25 Lorena Corfas Phone: +41 79 568 24 95 Simon Goldsborough Phone: +44 797 32 72 915 Karsten Kleine Phone: +41 79 461 86 83 Kirti Pandey Phone: +49 172 6367262 Yvette Petillon Phone: +41 79 961 92 50 Dr Rebekka Schnell Phone: +41 79 205 27 03 Roche Investor Relations Investor Relations North America Loren KalmPhone: +1 650 225 3217 e-mail: [email protected] Attachment Media Investor Release Elecsys pTau181 CE Mark English Disclaimer: The above press release comes to you under an arrangement with GlobeNewswire. Business Upturn takes no editorial responsibility for the same. Ahmedabad Plane Crash
Scotsman
28-06-2025
- Health
- Scotsman
Webinar welcomes national standards body for support on navigating new legislation
A free webinar has encouraged medical device innovators to learn more about new Post-Market Surveillance (PMS) legislation and how to successfully navigate it. Sign up to our Scotsman Money newsletter, covering all you need to know to help manage your money. Sign up Thank you for signing up! Did you know with a Digital Subscription to The Scotsman, you can get unlimited access to the website including our premium content, as well as benefiting from fewer ads, loyalty rewards and much more. Learn More Sorry, there seem to be some issues. Please try again later. Submitting... Hosting the educational session on Wednesday, June 25 – entitled ' The new Post-Market Surveillance legislation for medical devices - what you need to know' – formal NHS Scotland partner InnoScot Health believes it was a key opportunity to better understand the changes for Great Britain. The changes are intended to improve the safety of medical devices – including in vitro diagnostics (IVD) and active implantable devices – while providing certainty for manufacturers. Advertisement Hide Ad Advertisement Hide Ad Part of wider regulatory reform, the amended regulation will, the Medicines and Healthcare products Regulatory Agency (MHRA) says, 'introduce clearer and more risk-proportionate PMS requirements'. Head of Innovation, Robert Rea, InnoScot Health The 'lunch and learn' webinar was presented by Head of Regulatory Affairs Elaine Gemmell, who provided an overview of the complexities of the current landscape and outlined why it is vital to receive professional advice in order to navigate it successfully. She was joined by guest speakers from The British Standards Institution (BSI) – Damon Williams, Sales Manager – Medical Devices, UK & Ireland, and Umar Butt, Business Development Manager, North UK and Ireland. The national standards body of the United Kingdom, BSI is recognised through a Memorandum of Understanding with the UK Government, producing technical standards on a wide range of products and services. Advertisement Hide Ad Advertisement Hide Ad They spoke on the similarities and key deviations the UK PMS regulation has from EU MDR/IVDR and anticipated changes. User (UGC) Submitted Elaine said: 'Our June webinar was an opportunity to gain a more in-depth understanding of what is crucial new legislation for medical device manufacturers. 'Never more have we needed transformative approaches to healthcare for better patient outcomes, and new medical device breakthroughs are a key driver in realising that goal. 'But clearer, more robust post-market surveillance requirements are necessary to improve safety for both patients and public alike, and in greater alignment with international standards. Advertisement Hide Ad Advertisement Hide Ad 'In response, we now have an important amendment this month and manufacturers are advised to learn more. 'We believe attendees found it useful and instructive in taking practical steps.' The webinar was rounded off by an opportunity to ask questions of the speakers. The medical device industry has experienced unprecedented growth over recent years, and changes to the regulatory landscape mean it is vital innovators get the right advice, support and signposting to develop effective and innovative healthcare products.
Business News Wales
18-06-2025
- 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
