September 4, 2020 - Roche (Basel, Switzerland) announced that the cobas SARS-CoV-2 & Influenza A/B Test for use on the cobas 6800/8800 Systems received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA). This test is intended for the simultaneous qualitative detection and differentiation of SARS-CoV-2, Influenza A, and Influenza B in … [Read more...]
Roche to launch SARS-CoV-2 Rapid Antigen Test in countries accepting CE Mark
September 2, 2020 - Roche (Basel, Switzerland) announced it will launch a SARS-CoV-2 Rapid Antigen Test in late September for markets accepting the CE Mark. Roche also intends to file for Emergency Use Authorization (EUA) with the U.S. Food and Drug Administration (FDA). The SARS-CoV-2 Rapid Antigen Test is for use in point-of-care (POC) settings for both … [Read more...]
Roche receives FDA approval of FoundationOne Liquid CDx, comprehensive pan-tumor liquid biopsy test
August 28, 2020 - Roche (Basel, Switzerland) received U.S. Food and Drug Administration (FDA) approval for FoundationOne Liquid CDx, Foundation Medicine’s comprehensive pan-tumor liquid biopsy test for patients with solid tumors. FoundationOne Liquid CDx is a comprehensive genomic profiling (CGP) test that analyzes more than 300 cancer-related genes and multiple genomic … [Read more...]
Gain insights into COVID-19 testing options
From the upcoming September issue of Repertoire Magazine August 24, 2020 - Trying to make sense of the continually evolving information on coronavirus testing? Check out our quick, 7 minute educational video where Roche’s Medical and Scientific Affairs partner, Dr. John Osiecki, breaks down the different types of COVID-19 tests that are available today. In this … [Read more...]
Roche, Regeneron collaborate to increase global supply of REGN-COV2 investigational antibody combination for COVID-19
August 19, 2020 - Roche (Basel, Switzerland) and Regeneron are partnering to develop, manufacture and distribute REGN-COV2, Regeneron’s investigational antiviral antibody combination against COVID-19, to people around the globe. According to the companies, REGN-COV2 “could provide a much-needed treatment option for people already experiencing symptoms of COVID-19, and also … [Read more...]
FDA Approves Roche’s ENSPRYNG for Neuromyelitis Optica Spectrum Disorder (NMOSD)
August 17, 2020 - Roche (Basel, Switzerland) announced that the U.S. Food and Drug Administration (FDA) has approved ENSPRYNG (satralizumab-mwge) as the first and only subcutaneous treatment for adults living with anti-aquaporin-4 (AQP4) antibody positive neuromyelitis optica spectrum disorder (NMOSD). NMOSD is a rare, lifelong and debilitating autoimmune disorder of the … [Read more...]
FDA approves Roche’s Evrysdi (risdiplam) for treatment of spinal muscular atrophy (SMA) in adults, children
August 10, 2020 - Roche (Basel, Switzerland) received approval from the U.S. Food and Drug Administration (FDA) for Evrysdi (risdiplam) for the treatment of spinal muscular atrophy (SMA) in adults and children 2 months of age and older. Evrysdi showed clinically-meaningful improvements in motor function across two clinical trials in people with varying ages and levels of … [Read more...]
Roche receives FDA authorization for Epstein-Barr virus quantitative test on the cobas 6800/8800 Systems
August 06, 2020 - Roche (Basel, Switzerland) announced that the U.S. Food and Drug Administration (FDA) has authorized the cobas EBV test. This is the first quantitative in vitro diagnostic test for Epstein-Barr virus (EBV) DNA in the U.S., the company claims. The authorization gives healthcare professionals the ability to run a large number of patient tests for the … [Read more...]
Roche collaborates with Blueprint Medicines to bring a new treatment to people with RET-altered cancers
Roche (Basel, Switzerland) and Blueprint Medicines Corporation announced the signing of a licensing and collaboration agreement providing exclusive rights to Roche for global co-development and commercialization outside the U.S., excluding Greater China. In the U.S., Genentech, a member of the Roche Group, will obtain co-commercialization rights to pralsetinib, Blueprint … [Read more...]