Latest news with #MattSause
Yahoo
23-05-2025
- Business
- Yahoo
Roche announces new collaboration with Broad Clinical Labs to accelerate adoption of cutting-edge SBX sequencing technology
The strategic collaboration with Broad Clinical Labs will explore and develop applications using Roche's SBX sequencing technology1, with an initial focus on critically ill newborns and their parents. Whole genome sequencing can help diagnose babies with suspected genetic disorders, such as cystic fibrosis and sickle cell disease. This project will explore how this technology could become part of routine clinical practice for newborns, as well as its use in other research applications. Basel, 23 May 2025 – Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today a strategic collaboration with Broad Clinical Labs to develop and pilot groundbreaking applications using Roche's recently unveiled next-generation sequencing (NGS) Sequencing By Expansion (SBX) technology. This collaboration will focus on harnessing the power of the SBX technology to transform clinical genomics and biomedical discovery. It will also aim to establish the SBX technology as a routine offering for fast, scalable sequencing for Broad Clinical Lab's research community. The first project will see Broad Clinical Labs using the SBX technology to advance research into trio-based whole genome sequencing of critically ill newborns and their biological parents. This program aims to establish a future state where whole genome sequencing becomes a routine component of clinical care in neonatal intensive care units (NICUs) —enabling precise, timely diagnoses and improved outcomes for infants with suspected genetic disorders. 'The SBX technology was designed with both clinical impact and scientific discovery in mind, and offers the next-generation of fast, scalable sequencing solutions,' said Matt Sause, CEO of Roche Diagnostics. 'Collaborating with Broad Clinical Labs, a leader in clinical genomics and omics research, accelerates our ability to deliver on that promise and support better outcomes for patients through cutting-edge genomic technology.' 'Integrating the SBX technology into clinical and translational pipelines opens exciting new possibilities,' said Niall Lennon, Chair and CSO at Broad Clinical Labs. 'Together with Roche, we're aiming to demonstrate how fast, scalable, and high-quality sequencing can support both routine clinical care and drive biomedical innovation.' The SBX technology represents a significant leap forward in next-generation sequencing, offering ultra-fast turnaround times, exceptional scalability, and cost efficiency across a range of sequencing applications. The SBX technology has been tailored to deliver high-throughput performance with a flexible workflow that will support rapid deployment in time-sensitive settings like neonatal intensive care units (NICUs) and comprehensive multi-omic discovery research. The collaboration will also explore the capabilities of the SBX technology for RNA sequencing, including both bulk and single-cell approaches. These efforts will focus on leveraging the longer reads of the SBX technology to unlock novel molecular insights and data types that could reshape how researchers understand disease mechanisms and identify new therapeutic targets. Broad Clinical Labs is a wholly owned subsidiary of the Broad Institute of MIT and Harvard. Broad Institute researchers, who have led the field in the development and application of single cell methods across a range of biomedical areas, will be the early users to leverage the new system. The collaboration between Roche and Broad Clinical Labs reflects a shared vision of a genomics-enabled healthcare system and reinforces both organizations' commitment to advancing precision medicine at scale. About Sequencing by Expansion (SBX) technologyRoche's groundbreaking next-generation sequencing technology is designed to overcome the limitations of traditional sequencing methods. As well as high accuracy, it also offers an unparalleled combination of flexibility and speed, making it a versatile tool for a wide range of genomic applications. One of the key benefits of the SBX technology is its scalability. The chemistry is coupled with an advanced, high-throughput CMOS sensor module that enables ultra-rapid, real-time base calls and analysis. This module is designed to process numerous samples simultaneously, creating a highly scalable and flexible architecture for cost-efficient sequencing across different project sizes, from small-scale studies to large projects involving thousands of samples. This versatility makes the SBX technology suitable for a variety of applications, including whole genome sequencing, whole exome sequencing, and RNA sequencing. As a result, it holds promise not only for research laboratories but also eventually for clinical settings where detailed genomic insights are crucial. With SBX technology, researchers can meet new and evolving research demands efficiently, paving the way for significant advances in our understanding of genetics and disease, ultimately contributing to better healthcare outcomes. The SBX chemistry was invented by Mark Kokoris and Robert McRuer who co-founded Stratos Genomics. Stratos Genomics was acquired by Roche in 2020. To find out more about Roche's novel SBX technology, click here. About Broad Clinical LabsBroad Clinical Laboratories was founded in 2013 as a subsidiary of Broad Institute, Inc. to accelerate the world toward a better understanding, diagnosis, and treatment of disease by pursuing projects, developing products, and driving adoption of cutting edge -omics technologies and novel molecular assays. Broad Clinical Labs is a leader in human whole genome sequencing, having sequenced over 750,000 genomes in service of its mission to accelerate the understanding and diagnosis of human disease. For more information, please visit 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 The SBX technology is in development and not commercially available. The content of this material reflects current study results or design goals. Roche Global Media RelationsPhone: +41 61 688 8888 / e-mail: Hans Trees, PhDPhone: +41 79 407 72 58 Sileia UrechPhone: +41 79 935 81 48 Nathalie AltermattPhone: +41 79 771 05 25 Lorena CorfasPhone: +41 79 568 24 95 Simon GoldsboroughPhone: +44 797 32 72 915 Karsten KleinePhone: +41 79 461 86 83 Nina MählitzPhone: +41 79 327 54 74 Kirti PandeyPhone: +49 172 6367262 Yvette PetillonPhone: +41 79 961 92 50 Dr Rebekka SchnellPhone: +41 79 205 27 03 Roche Investor Relations Dr Bruno EschliPhone: +41 61 68-75284e-mail: Dr Sabine BorngräberPhone: +41 61 68-88027e-mail: Dr Birgit MasjostPhone: +41 61 68-84814e-mail: Investor Relations North America Loren KalmPhone: +1 650 225 3217e-mail: Attachment 23052025_SBX Broad Clinical Labs_enSign in to access your portfolio
Newsweek
16-05-2025
- Business
- Newsweek
The New Era of Life Sciences: The Future is Now
When we published our 2024 report, children suffering from Leber Congenital Amaurosis 4 (LCA4)—a severe inherited retinal dystrophy—had only hope that one day they might see the world. Today, thanks to an investigational gene therapy, we know that the 11 children who participated in the trials can, for the first time in their lives, discern a toy, recognize a human face and even spot a grain of sand. The biotech behind this achievement is MeiraGTx, which has now filed its therapy for approval under exceptional circumstances in the U.K., which would expedite the process. Stories like that of MeiraGTx illustrate the transformative power of gene therapies on patients. More broadly, they highlight the potential for rare diseases R&D to emerge as the principal driver of therapeutic innovation. "Rare diseases have become a critical area for exploring new treatment modalities because, in many cases, there is no existing therapy, or even a model. For patients who have no options, innovative approaches are important," shares Marc Dunoyer, the CEO of Alexion, the rare diseases subsidiary of AstraZeneca. Ironically, the very severity and uncommonness of these illnesses can also be a blessing, as it allows for bolder approaches by both researchers and regulators. Moreover, rare disease drugs have historically had higher approval success rates compared to other drugs. The Tufts Center for the Study of Drug Development found that orphan-designated drugs had a Phase-1-to-approval success rate of 17 percent, compared to 7.9 percent for non-orphan drugs. Benefiting from faster approval pathways and enhanced regulatory incentives, entrepreneurs in the field face better odds of innovating successfully. And when they do, the implications of their therapies go far beyond their original target. "Many of the advances seen today, such as gene editing and RNA-based therapies, originated in rare disease research before moving into larger indications," says Dunoyer. Arcturus Therapeutics, for instance, is addressing cystic fibrosis via a new delivery mechanism. "Our cystic fibrosis program is a prime example, where the ability to inhale mRNA safely could have a huge impact on the pharmaceutical industry. The rare disease field offers a shorter regulatory pathway to approval and a higher likelihood of success. This makes it an attractive space for evaluating next-generation technologies like mRNA therapeutics," shares Arcturus' CEO, Joseph Payne, as the company is expecting results from their Phase 2 trials in 2025. Matt Sause, CEO, Roche Diagnostics. Credit: Courtesy of Roche Diagnostics. Matt Sause, CEO, Roche Diagnostics. Credit: Courtesy of Roche Diagnostics. We can perform comprehensive genomic profiling to uncover the molecular basis of a tumor. This allows doctors to provide tailored treatments. Over time, this will enable us to move to a future where we understand the molecular drivers for cancer and can deliver truly personalized healthcare. Jacob Thaysen, CEO, Illumina. Credit: Courtesy of Illumina. Jacob Thaysen, CEO, Illumina. Credit: Courtesy of Illumina. Whether it is providing clarity for families dealing with rare genetic disorders or enabling rapid and precise cancer diagnoses, our goal is to ensure patients receive the answers they need when they need them. This report has been paid for by a third party. The views and opinions expressed are not those of Newsweek and are not an endorsement of the products, services or persons mentioned. Click here to download the full report
Yahoo
06-05-2025
- Health
- Yahoo
Roche introduces innovative Elecsys PRO-C3 test to improve precision in evaluating liver fibrosis severity
F. Hoffmann-La Roche Ltd Elecsys PRO-C3, used with the ADAPT formula (age, diabetes status, PRO-C3, platelets), assesses liver fibrosis severity – a disease responsible for approximately one in every 25 deaths worldwide 1 The test delivers results in just 18 minutes on Roche's cobas analysers, providing a fast and reliable diagnostic method. The test enables earlier identification of patients with significant liver fibrosis, potentially improving outcomes through timely management and access to emerging therapies. Basel, 06 May 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today the launch of its Elecsys® PRO-C3 test, a new diagnostic solution designed to assess the severity of liver fibrosis in patients showing signs of metabolic dysfunction–associated steatotic liver disease (MASLD). The test, developed in partnership with Nordic Bioscience, offers clinicians a simple and efficient method of identifying patients with liver fibrosis of varying severity, enabling timely intervention and appropriate management of the disease. MASLD affects around 30% of the population,2 and is one of the most common causes of chronic liver disease in the developed world.3 Caused mainly by diabetes, obesity and other cardiometabolic risk factors,3 a rapidly growing number of people are living with MASLD, representing a significant burden for patients and health systems worldwide. However, despite being responsible for approximately one in every 25 deaths globally,1 the liver fibrosis associated with MASLD is often asymptomatic until the advanced stages and can go undetected for years. Unmanaged, it can lead to severe consequences such as cirrhosis, liver cancer, and liver failure. "The Elecsys PRO-C3 test addresses an urgent need in the diagnosis, staging and management of liver fibrosis," said Matt Sause, CEO of Roche Diagnostics. "With MASLD affecting a growing number of people worldwide and new treatments emerging, it is critical to detect fibrosis accurately and early. Our innovative solution simplifies the diagnostic process and eases the burden on healthcare services, providing a clear and rapid assessment while reducing the requirement for invasive biopsies." Until recently, no medicines were available to treat MASLD, and disease management options were focused on lifestyle interventions such as diet and exercise. New drug treatments for liver fibrosis are now emerging, giving clinicians, for the first time, a means of improving liver function and slowing disease progression. The Elecsys PRO-C3 test requires only a single assay, which delivers results in only 18 minutes on Roche's cobas® analysers. This streamlines the process compared to currently available tests and reduces costs. Used in combination with the ADAPT formula,4 which includes PRO-C3 levels, platelet count, age and diabetes status, it provides a clear assessment of the severity of fibrosis, including distinguishing between different severities such as significant fibrosis (≥F2), advanced fibrosis (≥F3), and cirrhosis (F4). This is crucial for determining the appropriate treatment pathway for patients and identifying those who are eligible for new and emerging therapies.
Yahoo
05-05-2025
- Business
- Yahoo
FDA grants breakthrough status to Roche's VENTANA TROP2 device
The US Food and Drug Administration (FDA) has granted breakthrough device designation to Roche's computational pathology companion diagnostic (CDx) VENTANA TROP2 (EPR20043) RxDx device. Roche noted that this immunohistochemistry (IHC) assay is the first AI-driven companion diagnostic intended for use in determining non-small cell lung cancer (NSCLC). The VENTANA TROP2 device aims to help identify NSCLC subjects who are likely to benefit from Daiichi Sankyo and AstraZeneca's Trop2-directed antibody drug conjugate, Datroway's (datopotamab deruxtecan-dlnk) treatment. It is specifically indicated for patients with advanced or metastatic non-squamous NSCLC without actionable genomic alterations. The device comprises the TROP2 algorithm, Roche digital pathology scanners, navify Digital Pathology Image Management System, and the VENTANA TROP2 RxDx Assay, which is designed to work with the OptiView DAB Detection Kit to facilitate staining processes on the BenchMark ULTRA IHC/in situ hybridisation (ISH) staining instrument. It is designed to deliver a quantitative trophoblast cell surface antigen 2 (Trop2) score by analysing whole slide images of NSCLC tissue, which are stained with TROP2. Roche noted that incorporating AstraZeneca's Quantitative Continuous Scoring (QCS) platform, the algorithm achieves a level of diagnostic precision beyond traditional manual scoring methods. The breakthrough device status by the FDA will expedite the availability of the TROP2 CDx system. According to the company, a qualified pathologist plays a crucial role in reviewing staining and image quality, ensuring tumour detection sensitivity and precision. Following this assessment, the nDP TROP2 algorithm identifies tumour cells independently and calculates the normalised membrane ratio (NMR) score, classifying the TROP2 status as positive or negative based on a predefined cutoff. Roche Diagnostics CEO Matt Sause said: 'This FDA breakthrough device designation is another example of our commitment to deliver innovation that enables more precise diagnosis in oncology. 'This solution, which leverages our industry-leading expertise in companion diagnostics development, uses AI for a greater depth of sample analysis, helping to deliver truly personalised treatment.' Earlier this year, the company secured FDA 510(k) clearance for its Tina-quant Lipoprotein (a) Gen.2 Molarity assay. "FDA grants breakthrough status to Roche's VENTANA TROP2 device" was originally created and published by Medical Device Network, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Sign in to access your portfolio
Yahoo
23-04-2025
- Health
- Yahoo
Roche receives CE Mark for its Chest Pain Triage algorithm to enhance detection of Acute Coronary Syndrome (ACS)
Roche, in collaboration with Universitätsklinikum Heidelberg, has developed a Chest Pain Triage algorithm – a CE-marked IVD medical device1 set to transform cardiac care This novel algorithm offers a standardised assessment, helping emergency room doctors to make confident clinical decisions in ruling in or ruling out heart attacks (acute myocardial infarction) Cardiovascular disease causes a third of worldwide deaths2, with chest pain being the second highest reason for emergency department (ED) visits3 Basel, 23 April 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today the introduction of its innovative Chest Pain Triage algorithm as part of the navifyⓇ Algorithm Suite. This groundbreaking algorithm is designed to more quickly and accurately detect Acute Coronary Syndrome (ACS) in patients presenting with chest pain, one of the most common reasons for Emergency Department (ED) visits. As EDs are typically one of the most crowded hospital units, leading to challenges to swiftly diagnose critical conditions, such as chest pain.4 This new algorithm was developed in collaboration with Universitätsklinikum Heidelberg. The Chest Pain Triage algorithm leverages state-of-the-art diagnostic technologies, including high-sensitivity cardiac troponin testing, to provide healthcare professionals with timely and reliable data to differentiate between cardiac and non-cardiac chest pain. This advanced algorithm is part of a wider integrated offering from Roche to address ACS, including the use of the cardiac troponin T Assay and integration with existing lab solutions, offering an efficient and comprehensive approach to patient triage in emergency settings. The Chest Pain Triage algorithm also leverages the European Society of Cardiology's (ESC) guidelines, and leading cardiologists and emergency medicine experts contributed to the development of the algorithm. "The introduction of our Chest Pain Triage algorithm underscores Roche's commitment to improving care for cardiovascular disease, one of the world's largest health burdens," said Matt Sause, CEO, Roche Diagnostics. "One of the major challenges in managing chest pain in the emergency department is the length of stay, especially since some patients aren't actually having a heart attack. Our Chest Pain Triage algorithm can help doctors quickly decide who needs urgent cardiac care and who could be discharged sooner. With an early rule-out pathway, we can cut down Emergency Department visit times by over three hours.5' The new algorithm aims to identify patients genuinely at risk by accurately identifying non-cardiac chest pain cases through a definitive Rule-In, Rule-Out or Observe recommendation according to the ESC guidelines. The algorithm simplifies decision making by automatically selecting the proper ESC 0/1, 0/2, or 0/3 accelerated pathway, based on the timing of the blood sample collection. This has the potential to reduce unnecessary hospital admissions and associated costs. The algorithm also expedites the treatment process for patients with true ACS with Rapid Assessments of chest pain onset more than three hours before the first blood sample. In addition, it includes a medical dossier for clinician support, and simplifies documentation by allowing doctors to easily copy recommendations and results into patient records. For more information, please visit the Chest Pain Triage algorithm site. The development of the Chest Pain Triage algorithm is part of Roche's commitment to early identification and treatment of Cardiovascular disease. The algorithm is available in Europe, the Middle East, and Asia, with availability in the United States at a later date, through Roche's navify Algorithm Suite, and can be integrated into current emergency department workflows*. Roche's cardiometabolic portfolio supports faster and more accurate triage decisions, and future ACS offerings will combine next-generation digital algorithms, biomarkers, near patient care devices, and laboratory analyzers. The navify Algorithm Suite is a cloud-based platform hosting clinical algorithms from Roche and partners. It provides labs and hospitals with direct workflow integration through Electronic Health Records (EHR) and Lab Information Systems (LIS) for faster and more efficient processes. About navify The navify portfolio from Roche includes more than 30 digital solutions for labs, hospitals and patients worldwide. navify solutions connect the healthcare community with a robust digital infrastructure to integrate data efficiently and to accelerate clinician access to innovations as well as operational and medical insights. This work includes collaborating with other innovative companies such as Fortinet in cybersecurity services. The navify platform is designed to deliver security at every step of the data analytical process. All data is encrypted at rest and in transit. The solution is operated in compliance with applicable laws and regulations in the USA with HIPAA (Health Insurance Portability and Accountability) as well as with GDPR (General Data Protection Regulation) regulations in Europe. Healthcare professionals can visit navify Marketplace to browse and request a growing number of next generation digital solutions from Roche and other companies — all designed to drive operational and clinical excellence, built on the foundational pillars of digital trust. More information is also available at 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. * Availability will depend on the specific market and country in some cases. Please consult a local Roche representative for the availability of the chest pain algorithm in your market References [1] European Union: EUR-Lex. Chest Pain Triage algorithm registration [Internet: accesses March 24, 2025] Chest Pain Triage algorithm is an in-vitro diagnostic (IVD) medical device CE-marked (NB 0123) under the requirements laid out in the IVD regulation (EU) 2017/746 (IVDR). [2] Saloni D et al. Cardiovascular Diseases. [Internet: accessed March 24, 2025]. Available from: [3] Yukselen Z, Majmundar V, Dasari M, Arun Kumar P, Singh Y. Chest Pain Risk Stratification in the Emergency Department: Current Perspectives. Open Access Emerg Med. 2024 Feb 4;16:29-43. doi: 10.2147/OAEM.S419657. PMID: 38343728; PMCID: PMC10853047 [4] Sartini M, et al. Overcrowding in Emergency Department: Causes, consequences, and solutions – a narrative review. Healthcare (Basel). 2022 Aug;10(9):1625) [5] Anand A, et al. High-sensitivity cardiac troponin on presentation to rule out myocardial infarction: A stepped-wedge cluster randomized controlled trial. Circulation. 2021 Jun;143(23):2214-2224) Roche Global Media Relations Phone: +41 61 688 8888 / e-mail: 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 Nina Mählitz Phone: +41 79 327 54 74 Kirti Pandey Phone: +49 172 6367262 Yvette Petillon Phone: +41 79 961 92 50 Dr Rebekka Schnell Phone: +41 79 205 27 03 Attachment 23042025_MR_Roche navify chest pain_en
