SARS-CoV-2
If authorized by the FDA, the Proof Lab Test System may be used to deliver accurate, actionable, lab-quality results for COVID-19 (SARS-CoV-2) in as little as 18 minutes Excerpt from the Press Release: CAMBRIDGE, Mass., April 7, 2022 /PRNewswire/ — Proof Diagnostics, Inc., an innovative healthcare technology company delivering innovative solutions in molecular diagnostics, today announced the submission…
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Transfer of Trial Sponsorship Final Major Milestone before Initiation of Lung Failure Pivotal Clinical Trial Excerpt from the Press Release: CEANSIDE, Calif.–(BUSINESS WIRE)–Therapeutic Solutions International announced today the execution of a purchase agreement covering sponsorship and leadership of the FDA cleared Phase III pivotal trial assessing JadiCell adult stem cells for treatment of COVID-19 associated…
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BioFluidica LiquidScan Next-Generation Testing Platform, Can Detect Diseases in 15 Minutes Excerpt from the Press Release: SAN DIEGO, March 23, 2022 /PRNewswire/ — BioFluidica, a privately held biotechnology company, today announced they have been awarded a continuation grant from the Midwest Biomedical Accelerator Research Consortium (MBArC) on behalf of the National Institutes of Health Rapid Acceleration of…
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Excerpt from the Press Release: DEL MAR, Calif,, March 23, 2022 /PRNewswire/ — Two years into the COVID-19 pandemic there is still a need for vaccines to effectively control the spread of novel SARS-CoV-2 variants and associated cases of severe disease. The current vaccines offer limited protection over time against the omicron variant that is now dominating…
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Thermo Fisher Scientific to Support National Program to Accelerate SARS-CoV-2 Variant Identification
Excerpt from the Press Release: CARLSBAD, Calif.–(BUSINESS WIRE)–Thermo Fisher Scientific Inc., the world leader in serving science, today announced its collaboration with the National Institutes of Health (NIH) Rapid Acceleration of Diagnostics (RADx) Initiative, Helix, and Rosalind aimed at developing a new genotyping method for SARS-CoV-2 that could speed up the identification of variants as…
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CiVax™ booster vaccine administered seven months after primary vaccination with COVID-19 adenovirus vaccine shows rapid enhancement of neutralizing antibody responses in non-human primates Neutralizing antibodies against Delta and original strain increased by up to 27-fold within one week and up to 243-fold within three weeks Omicron neutralizing antibody levels were undetectable prior to booster vaccination, and…
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Second largest study to date in COVID-19 outpatients (N=1,936) Highly superior compared to placebo, with a probability of superiority of 99.91% on the primary endpoint 60% reduced risk of COVID-19-related death Primary endpoint achieved across multiple SARS-CoV-2 variants, including omicron Eiger plans to submit data to FDA for Emergency Use Authorization (EUA) Management to host…
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FDA granted IND clearance today for STI-9199 (COVISHIELD™) for a Phase 1 safety and pharmacokinetic study in healthy volunteers. Initial trials are expected to be followed by a multinational Phase 2/3 trial in both mild and moderate COVID-19 patients. STI-9199 has demonstrated in vitro and in vivo activity against all SARS-CoV-2 variants tested, including the…
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– Roche continues to increase access to accurate, timely and reliable diagnostics in the fight against COVID-19 by expanding the COVID-19 PCR portfolio on the cobas 5800 System – These tests are for the qualitative detection of SARS-CoV-2 and the qualitative detection and differentiation of SARS-CoV-2, influenza A virus, and/or influenza B virus – As…
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Excerpt from the Press Release: CARLSBAD, Calif.–(BUSINESS WIRE)–ChromaCode, Inc., a company redefining molecular testing through data science, announced today that the U.S. Food and Drug Administration has expanded the Emergency Use Authorization of ChromaCode’s HDPCR SARS-CoV-2 Assay to include several new qPCR instruments and use of 384-well plates, which has the potential to more than…
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