- CE-IVD marked software as a medical device that aids clinicians to more easily interpret NGS oncology tests
- Classifies detected variants in accordance to up-to-date literature and local medical guidelines
- Informs on actionable therapies and clinical trial options
Pleasanton, Ca, March 21, 2019 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the CE-IVD mark and launch of NAVIFY Mutation Profiler, clinical software that provides annotation, interpretation and clinical reporting of next-generation sequencing (NGS) tests, and the launch of NAVIFY Therapy Matcher, an optional clinical decision support app that further aids clinicians in linking clinically actionable mutations to relevant therapy options.
Clinical labs looking to develop or install NGS testing in-house today face a number of challenges. Among the greatest obstacles cited is the complexity of interpretation and the challenge of providing meaningful reporting to clinicians. NAVIFY Mutation Profiler empowers diagnostic labs to overcome these challenges by simplifying how labs report on their NGS tests.
“We are excited with the launch of NAVIFY Mutation Profiler and NAVIFY Therapy Matcher. Together they offer a clinical decision support solution that addresses a major workflow challenge for NGS labs, synthesizing large amounts of medical and scientific data into actionable insights,” said, Neil Gunn, Head of Roche Sequencing Solutions.
“Precision medicine requires precision in clinical interpretation and reporting. With NAVIFY Mutation Profiler our lab has access to the most clinically relevant and up-to-date information, drastically reducing our curation time,” said Professor Markus Tiemann, Institut für Hämatopathologie Hamburg. “The intuitive software produces concise, actionable reports that accelerate our clinicians’ ability to deliver the best treatment options for our patients.”
About the NAVIFY Decision Support portfolio
The NAVIFY Decision Support portfolio helps healthcare professionals navigate increasing complexity of medical and scientific information by transforming large amounts of data into actionable insights. With the launch of NAVIFY Mutation Profiler, Roche expands its NAVIFY Decision Support portfolio, moving one step closer to personalized healthcare. Together with NAVIFY Tumor Board, and the integrated NAVIFY Clinical Decision Support apps, NAVIFY Mutation Profiler helps to better bridge precision diagnostics with personalized clinical management. The portfolio has the power to fundamentally change the way oncology teams manage care for cancer patients across the continuum of care. The NAVIFY portfolio is continuously evolving to include additional workflow products and clinical decision support applications that will aid the transformation of healthcare delivery.
Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible.
Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management.
Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. Thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Moreover, for the tenth consecutive year, Roche has been recognised as the most sustainable company in the Pharmaceuticals Industry by the Dow Jones Sustainability Indices (DJSI).
The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2018 employed about 94,000 people worldwide. In 2018, Roche invested CHF 11 billion in R&D and posted sales of CHF 56.8 billion. 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 www.roche.com.
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