Abbott Laboratories received FDA emergency use authorization (EUA) for its COVID-19 molecular test, which will run on the company's new Alinity m system, as well as its COVID-19 antibody blood test, which will run on the Alinity i system. The two actions bring to five the number of COVID-19 tests developed by the Abbott Park, Ill.-based company to receive EUAs.
The May 12 Senate hearing regarding the COVID-19 pandemic included the usual conversations about contact tracing, but Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said he is “cautiously optimistic” that one of the vaccines currently in trial in the U.S. will work, but that it is unlikely a vaccine will be ready by September 2020. In contrast, Assistant Secretary for Health Brett Giroir said testing capacity may reach 50 million tests per month by that time, thanks in part to the fact that antigen testing is now part of the FDA’s emergency use authorization mechanism.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Caption Health, Cardiofocus, Cytosorbents, Helius Medical Technologies, Optiscan Biomedical, Ortho Clinical Diagnostics, Thermo Fisher Scientific, Transit Scientific.
DUBLIN – The Innovative Medicines Initiative (IMI), a public-private research partnership between the European Commission (EC) and Europe’s pharmaceutical industry, has boosted funding for a fast-track response to the COVID-19 pandemic from €45 million (US$48.8 million) to €72 million.
The U.S. FDA has issued an emergency use authorization (EUA) for an antigen test for the SARS-CoV-2 virus from Quidel Corp., of San Diego, that is more readily deployed than other diagnostic tests for the pathogen. Quidel’s offering can be used at the point of care (POC) and as a lab test.
The U.S. FDA has expanded the emergency use authorization (EUA) for Rutgers University’s saliva-based COVID-19 test to include at-home use of Spectrum Solutions LLC’s SDNA-1000 whole saliva collection device, a development that underscores the need for wider testing as localities across the country emerge from lockdown and restart their economies. This is the first at-home option for saliva collection; the action comes just two weeks after the FDA authorized Laboratory Corp. of America’s polymerase chain reaction test for SARS-CoV-2, the virus that causes COVID-19, to include the company’s Pixel self-collection kit for nasal samples.
HONG KONG – Blockchain technology usually is associated with digital currencies. However, it’s now emerging as an important platform for COVID-19 management. It’s been a focus in China, where a top-down approach is key to driving sectors and technology.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Accelmed, Aidoc, Avita Medical, Bellerophon Therapeutics, Datametrex AI, Fresenius Medical Care North America's Renal Therapies Group, Gaia, Inspire Medical Systems, Kc Wearable, Mevion Medical Systems, Orexo, Perkinelmer, Quest, Rochal Industries, Sanara Medtech, Seevix, Tearlab, Technopath, Telemedicine Clinic, Tissue Regenix, Unilabs, Zoll.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbott, Aspenstate, Elemaster, Myriad, Visioncare.