Latest news with #InVitroDiagnosticRegulation
Business Upturn
23-07-2025
- 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
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)"
Korea Herald
08-05-2025
- Health
- Korea Herald
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 EU market. DNV offers device manufacturers a fully digital process for faster, more transparent device certification. In vitro diagnostics (IVDs) are tests used to determine a person's health status. They range from pregnancy and cholesterol tests through to HIV screening, COVID-19 tests and cancer marker detection. The safety and effectiveness of such devices is therefore crucial to public and personal health. The EU introduced the IVDR in 2017, replacing its previous In Vitro Diagnostic Directive 98/79/EC (IVDD). The IVDR provides a regulatory basis for establishing the safety and effectiveness of new IVD devices. A certificate of compliance with the IVDR will be required for most IVD device to be sold in the EU. Devices are classified according to their risk to public and personal health. Class D devices, with the highest risk, will require IVDR certification from May 2025. Class C and Class B will require IVDR certification from May 2026 and May 2027 respectively. The designation of DNV as an IVDR notified body brings greater capacity to the certification market, helping more device manufacturers access the EU market. To further streamline access to market, DNV has a fully digital certification process. Manufacturers will be able to manage certification documents online and track compliance status in real time via a secure digital platform, for faster certification with greater transparency. "DNV is looking forward to working with manufacturers of all classes of IVD devices to help them access the EU market," said Cecilie Gudesen Torp, Global Director Medical Services, Supply Chain & Product Assurance at DNV. "Being in the top 5 notified bodies for medical device certification, we offer extensive expertise and technical competence. Our global team of auditors, technical assessors and clinicians are ideally positioned to deliver efficient certification with uncompromising reliability to reduce risks and help manufacturers get to market faster."
Associated Press
26-02-2025
- Health
- Associated Press
Biomerica Achieves IVDR Certification in the European Union for Food Intolerance Tests Targeting Crohn's Disease and Ulcerative Colitis
Significant Milestone: Biomerica secures IVDR (In Vitro Diagnostic Regulation) certification, ensuring compliance with stringent European Union standards and allowing sales of the products in the EU Focus on Precision Medicine: Certification covers Biomerica's food intolerance products developed to support patients with Crohn's Disease and Ulcerative Colitis (UC), both of which are chronic and debilitating inflammatory bowel diseases (IBD). Global Reach: Positions Biomerica to expand its presence in the European market while adhering to the highest standards of safety, quality, and performance. IRVINE, Calif., Feb. 26, 2025 (GLOBE NEWSWIRE) -- Biomerica, Inc. (Nasdaq: BMRA), a global leader in advanced medical diagnostic solutions, is proud to announce that its food intolerance products for Crohn's Disease and Ulcerative Colitis have achieved CE-marking under the European Union's new In Vitro Diagnostic Medical Devices Regulation (IVDR – 2017/746). This certification marks a significant milestone for Biomerica, underscoring the company's commitment to expanding its products in international markets. The newly approved food intolerance products are designed to address the growing need for non-invasive and personalized therapies to manage Crohn's Disease and Ulcerative Colitis, conditions affecting millions worldwide. The IVDR framework, implemented to enhance the safety, quality, and performance of in-vitro diagnostics across Europe, introduces rigorous new requirements. Biomerica's food intolerance products successfully met these General Safety and Performance Requirements (Annex I of IVDR 2017/746), demonstrating the company's ability to deliver innovative solutions that improve patient outcomes. IVDR certification can also be the basis for easier market access in other international markets outside of Europe with stringent regulatory approval processes, as many countries recognize the EU IVDR certification. Improving Care for Crohn's Disease and Ulcerative Colitis Patients Biomerica's food intolerance products use proprietary technology to identify specific foods that may trigger inflammation in Crohn's Disease and Ulcerative Colitis patients. By addressing dietary triggers, these products offer a novel, personalized approach to managing symptoms and improving quality of life. 'Achieving IVDR certification is a testament to our dedication to creating diagnostic products that achieve the highest technical standards,' said Zack Irani, CEO of Biomerica. 'This certification not only validates the safety and effectiveness of our products but also positions Biomerica to expand sales of these products in the European market. We are committed to providing innovative, non-invasive solutions that enhance patient care and address unmet medical needs. Our teams are now finalizing the materials for product launch in the near future.' Expanding Biomerica's Global Presence With this certification, Biomerica is positioned to expand its presence in the European In Vitro diagnostic market. The company continues to leverage its expertise in developing products that target one of the root causes of inflammation in chronic diseases, aligning with its global growth strategy to serve both patients and healthcare providers. About Crohn's Disease and Ulcerative Colitis Crohn's Disease and Ulcerative Colitis are chronic inflammatory bowel diseases affecting millions of people worldwide. Symptoms include abdominal pain, diarrhea, and rectal bleeding, significantly impacting patients' quality of life. Current treatment options often involve medications with potential side effects, underscoring the need for alternative approaches like Biomerica's food intolerance products. The market for Crohn's Disease and Ulcerative Colitis treatments is substantial and growing. The global UC market is expected to grow from $7.72 billion in 2024 to $12.03 billion by 2032, with a CAGR of 5.7%. Globally, the Crohn's Disease therapeutics market was estimated at $13.2 billion in 2023. These figures highlight the increasing demand for effective, non-invasive solutions to help manage the disease and improve patient outcomes. About Biomerica (NASDAQ: BMRA) Biomerica, Inc. ( is a global biomedical technology company that develops, patents, manufactures and markets advanced diagnostic and therapeutic products used at the point-of-care (in home and in physicians' offices) and in hospital/clinical laboratories for detection and/or treatment of medical conditions and diseases. The Company's products are designed to enhance the health and well-being of people, while reducing total healthcare costs. Biomerica primarily focuses on gastrointestinal and inflammatory diseases where the Company has multiple diagnostic and therapeutic products in development. The Private Securities Litigation Reform Act of 1995 provides a 'safe harbor' for forward-looking statements. Certain information included in this press release (as well as information included in oral statements or other written statements made or to be made by Biomerica) contains statements that are forward-looking, such as statements relating to the Company's inFoods® IBS test and other diagnostic tests, international regulatory clearance, FDA clearance or possible future clearance of the Company's diagnostic tests and other products, timing of the commercial launch of any of the company's tests and products, possible future revenues from the sale of the company's tests and products, growth in future revenues from the sale of the company's tests and products, acceptance of the company's tests and products by physicians and their patients, international regulatory approval and sales of the company's tests and products, accuracy, efficacy and clinical trial results of the company's tests and products, the rapidity of testing results, , discussions with physicians and physician groups who could or would offer the company's tests and products to their patients, efficacy of the company's tests and products to improve GI disease symptoms in patients, the company's ability to manufacture their tests and products, and to increase manufacturing capacity to meet future product demands, the uniqueness of the Company's tests and products, pricing of the Company's tests and products, future possible insurer reimbursement for the company's tests and products, patent protection on the underlying technology of the tests and product, and current or future competition for the company's tests and products from other medical manufacturers or distributors. Such forward-looking information involves important risks and uncertainties that could significantly affect anticipated results in the future, including, without limitation: results of studies testing the efficacy of the Company's tests and products; regulatory approvals necessary prior to commercialization any of the Company's products; availability of the Company's test kits and other products; capacity, resource and other constraints on our suppliers; dependence on our third party manufacturers; dependence on international shipping carriers; governmental import/export regulations; demand for our various tests and other products; competition from other similar products and from competitors that have significantly more financial and other resources available to them; governmental virus control regulations that make it difficult or impossible for the company to maintain current operations; the Company's ability to comply with current and future regulations in the countries where our products are made and sold and the Company's ability to obtain patent protection on any aspects of its rapid test technologies. Accordingly, such results may differ materially from those expressed in any forward-looking statements made by or on behalf of Biomerica. Additionally, potential risks and uncertainties include, among others, fluctuations in the Company's operating results due to its business model and expansion plans, downturns in international and or national economies, the Company's ability to raise additional capital, the competitive environment in which the Company will be competing, and the Company's dependence on strategic relationships. The Company is under no obligation to update any forward-looking statements after the date of this release. Corporate Contact: Zack Irani 949-645-2111
