December 12, 2024
In 2024, Roche continued to make significant advances in diagnostics through innovation, simplicity and collaboration – all to help improve patient care across the U.S. Working with our partners, we introduced groundbreaking technologies and streamlined solutions focused on delivering accessible, impactful diagnostics that make a difference. Explore how our efforts are shaping the future of healthcare and strengthening our commitment to our customers and the patients they serve.
Science is at the core of everything we do. In 2024, our science-based advancements included the pTau217 biomarker1 for Alzheimer’s disease research and the HPV self-collection solution – a groundbreaking solution that pushes the boundaries of innovation, empowering earlier detection and improved outcomes. By focusing on transformative technologies and pioneering research, we demonstrate our deep commitment to addressing today’s healthcare challenges and shaping the future of disease research.
We are dedicated to simplifying diagnostics to make healthcare more efficient and accessible. Some of our many significant milestones in 2024 include the deployment of 100 cobas® 5800 systems and the launch of innovative solutions like the cobas® liat SARS-CoV-2, Influenza A/B and RSV test.2 We’re introducing new assays and tools designed for seamless integration and improved workflow efficiency, enabling labs to deliver faster, more reliable results. These advancements reflect our commitment to operational simplicity, empowering healthcare providers to focus on what matters most: better outcomes for patients
At Roche, we know that collaboration is key to transforming healthcare. In 2024, our partners continued to play vitally important roles in supporting seamless transitions to new technologies – for example, the launch of HPV on the cobas® 5800 system. We continue to work alongside world-class healthcare providers to deliver impactful diagnostic solutions, earning accolades from 94% of customers for our commitment to service performance.3 Together with our partners, we will continue delivering meaningful change to help improve patient care and outcomes.
Our pTau217 assay* is mentioned in one of TIME's Best Inventions of 2024 in the Medical Care category. These medical innovations and partnerships aim to make diagnosis of Alzheimer's disease more accessible and effective.
*The pTau217 assay is available for research use only, not for use in diagnostic procedures. A similar version of the assay is under development and received FDA Breakthrough Device Designation.
Roche is proud to be the recipient of six IMV ServiceTrakTM awards, presented this week at the Association of Diagnostics and Laboratory Medicine (ADLM) annual industry conference.
Roche announced on April 11, 2024, that its Elecsys pTau217 assay received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA).
Get ready to experience new possibilities in clinical chemistry with the cobas® c703 and ISE neo analytical modules. The cobas® c703 and ISE neo are in development and are not available for sale or distribution in the US. A 510(k) submission is pending with the FDA.
Roche announced FDA approval of its human papillomavirus (HPV) self-collection solution, one of the first in the U.S. With over half of U.S. cervical cancer patients underscreened and more than 13,000 diagnoses annually, this innovative option empowers women to privately collect their own samples in a healthcare setting, improving access to testing and enabling early detection of this preventable disease.
Roche announced on May 15, 2024, the U.S. Food and Drug Administration (FDA) approval of its human papillomavirus (HPV) self-collection solution, one of the first available in the United States. This solution was also recognized in TIME's Best Inventions of 2024 in the Medical Care category.
Roche introduces the rebranded and improved cobas® eplex system highlighting a commitment to continuous product improvement across the entire platform, from raw materials to manufacturing and quality control.
Roche strengthens CGP portfolio offering with focused efforts to accelerate additional sequencer compatibility, automation, and a novel complex signature, HRDsig.
Roche announced on June 10, 2024, that the U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for its cobas® liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test, an automated, multiplex, real-time polymerase chain reaction (RT-PCR) assay on the cobas® liat system.
Roche has secured regulatory clearance to acquire LumiraDx’s innovative Point of Care technology, paving the way for a game-changing addition to its diagnostics portfolio. This integration will enhance decentralized testing solutions, bringing advanced, accessible care to primary settings across the globe.
Effective and integrated point-of-care testing and treatment are essential to curb transmission rates for sexually transmitted infections (STIs) like chlamydia, gonorrhea and syphilis.
Leaders from Vanderbilt Health discuss their organization's strategies to implement tenets of diagnostic stewardship into their respiratory testing algorithms to improve patient care.
Roche announced on October 18, 2024, that the VENTANA® Claudin 18 (43-14A) RxDx Assay is the first U.S. Food and Drug Administration (FDA) approved immunohistochemistry (IHC) companion diagnostic for determining CLDN18 protein expression in tumors of patients with gastric or gastroesophageal junction (GEJ) adenocarcinoma.
The PATHWAY HER2 (4B5) test helps identify patients with previously treated, unresectable or metastatic HER2-positive biliary tract cancer (BTC) who may be eligible for treatment with ZIIHERA.
The American Society for Colposcopy and Cervical Pathology (ASCCP) Guidelines have been updated to include dual-stain biomarker as an acceptable triage option for high-risk HPV positive test results.
VENTANA DP 200 cleared for IVD use as an aid to the pathologist to review and interpret digital images
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