There will be lessons learned aplenty when the COVID-19 pandemic finally breaks, including how serological and molecular testing can be used to maximum effect to corral a future pandemic.
The age of molecular testing for the COVID-19 pandemic is still with us, but the emphasis in the months ahead will be on serological testing as a quicker, more useful mass testing alternative. However, test developers have a number of hurdles to overcome in devising these serological tests, including that antibodies for the virus’s antigens emerge at different times in the disease cycle, just one of several challenges that have to be met in the effort to bring the SARS-CoV-2 virus to heel.
Since April 10, 2020, the FDA has issued emergency use authorizations (EUAs) to several companies that make blood purification devices that can clear excess cytokines in the blood of patients with COVID-19. Monmouth Junction, N.J.-based Cytosorbents Corp.; Lakewood, Colo.-based Terumo BCT Inc.; and Marker Therapeutics AG, a subsidiary of Marker AG, of Zug, Switzerland, have all recently received EUAs for use of their products in adults with confirmed COVID-19 infections who are admitted to intensive care.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Advanced Sterilization Products, Axonics, Becton Dickinson, Intact Vascular, The Learning Corp, Mobidiag, Spectral.
DUBLIN – Sanofi SA and Glaxosmithkline plc are lending their considerable weight to the urgent global effort to develop a vaccine for COVID-19 by teaming up to develop an adjuvanted recombinant subunit vaccine that will employ technologies from each company. Paris-based Sanofi is contributing its recombinant spike protein antigen and its baculovirus expression system, which is also the basis of its U.S.-licensed influenza vaccine Flublok. London-based GSK is contributing its pandemic adjuvant technology.
The U.S. FDA’s routine guidance agenda may be badly disrupted by the COVID-19 outbreak, but the agency continues to pump out guidances and emergency use authorizations (EUAs) directed to the pandemic. While the FDA has included only one serological test under the diagnostic EUA paradigm, Rep. Diana DeGette penned a letter inquiring into when the agency intends to move more decisively on serological tests, arguing that the absence of action on this front endangers the nation’s economic health as well as the public’s health.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Johnson & Johnson, Takeda Pharmaceutical.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Apollo Endosurgery, Atricure, Eos imaging, Kolon Tissuegene, Piranha Medical, Pluristem, Predictive Biotech, Predictive Technology, Rethink My Health, Scworx, Shockwave Medical, Staar Surgical.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Allen Technologies, Alphatec Holdings, Auburn University, Avacta Group, Biobot Analytics, Biodesix, Chembio Diagnostics, Cryo Innovations, Cytiva, Genomoncology, Hai Kang, HPC-AI, Integra Lifesciences, Intuitive, JMA, Labcorp, Myomo, Myriad, Nanomix, National Supercomputing Centre, Novacyt Group, Organovo, Pacific Biosciences of California, Pharmacyte, Phunware, Ping An Good Doctor, Predictive Laboratories, Resolution Medical, Roji Health Intelligence, Tarveda Therapeutics, Vitalhub, Wellgistics.
