AI-Driven Ruleset Helps Detect COVID-19 Novel Coronavirus in Patients
Persivia (Marlborough, MA), a provider of real-time bundled payment, value-based care, population health, and quality management solutions, has launched a new COVID-19 surveillance module within its Soliton AI engine. Delivered as part of its CareSpace platform, the module uses data from multiple sources to identify patients who could be infected with COVID-19 novel coronavirus. Given the shortage of tests for COVID-191, the ruleset will help healthcare professionals more effectively target patients who need to be tested. More...26 Mar 2020
Researchers Attach Coronavirus to Genetically Modified Measles Vaccine
Researchers from the University of Pittsburgh’s Center for Vaccine Research (CVR; Pittsburgh, PA; USA) are developing a SARS-CoV-2 vaccine using a measles vector — meaning a measles vaccine engineered to express SARS-CoV-2 proteins on its surface — to generate immunity to the virus. CVR is a part of an international consortium led by Institut Pasteur (Paris, France) in collaboration with Themis Bioscience GmbH (Vienna, Austria) to develop a SARS CoV 2 vaccine and take it through phase I clinical trials in humans. The Coalition for Epidemic Preparedness Innovations (CEPI), an international, intergovernmental organization, is committing about USD 5 million to the consortium. More...26 Mar 2020
LexaGene Accelerates FDA EUA Submission of Rapid, Onsite Analyzer for Detection of COVID-19
LexaGene Holdings, Inc. (Beverly, MA, USA), a biotechnology company, is accelerating its Food and Drug Administration (FDA) Emergency Use Authorization (EUA) submission for its rapid, onsite analyzer for the detection of novel infectious diseases such as COVID-19. More...26 Mar 2020
Hologic’s Panther Fusion SARS-CoV-2 Assay Receives FDA Emergency Use Authorization
Hologic, Inc. (Marlborough, MA, USA) has received Emergency Use Authorization (EUA) by the US Food and Drug Administration (FDA) for its new Panther Fusion SARS-CoV-2 assay, a molecular diagnostic test that detects SARS-CoV-2, the virus that causes COVID-19 disease. More...26 Mar 2020
Roche Initiates Phase III Clinical Trial for Patients Hospitalized with Severe COVID-19 Pneumonia
Roche (Basel, Switzerland) has begun working with the Food & Drug Administration (FDA) to initiate a randomized, double-blind, placebo-controlled Phase III clinical trial in collaboration with the Biomedical Advanced Research and Development Authority (BARDA), a part of the US Health and Human Services Office of the Assistant Secretary for Preparedness and Response (ASPR), to evaluate the safety and efficacy of Actemra/RoActemra (tocilizumab) plus standard of care in hospitalized adult patients with severe COVID-19 pneumonia as compared to placebo plus standard of care. More...26 Mar 2020
bioMérieux Receives Emergency Use Authorization for BIOFIRE COVID-19 Test
bioMérieux’s (Marcy-l'Étoile, France) subsidiary, BioFire Defense, has received Emergency Use Authorization (EUA) by the US Food and Drug Administration of its BIOFIRE COVID-19 test for use in CLIA moderate and high complexity clinical laboratories to detect SARS-CoV-2. More...26 Mar 2020
Quidel Receives FDA Emergency Use Authorization for Molecular COVID-19 Diagnostic Assay
Quidel Corporation (San Diego, CA, USA), a provider of rapid diagnostic testing solutions, cellular-based virology assays and molecular diagnostic systems, has received Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) to market its Lyra SARS-CoV-2 Assay, a real-time RT-PCR test intended for the qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal or oropharyngeal swab specimens from patients suspected of COVID-19. More...25 Mar 2020
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