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Oldest Black church in Fairfax County.… https://t.co/VbLC6grv8n about 13 hours ago Food and Drug Administration granted an emergency authorization for a molecular test for SARS-CoV-2 viruses done at… https://t.co/0vVMLb95bb about 1 day ago New post on : FDA Authorizes Non-Prescription Covid-19 Test https://t.co/eUj4uAqW1f #Science #Business about 1 day ago A clinical trial testing multiple treatments for people hospitalized with Covid-19 infections is dropping two thera… https://t.co/ptgpXEszkf about 2 days ago Guest Posts Tissue Culture: A Novel Propagation Method for Cannabis Industry Take care of your liver !!! … Stay healthy How to Successfully Integrate a Remote Developer Into Your Current Team Private Messenger: Leakage-Free Personal Info Encrypted Private Messenger and Multi-Purpose Ecosystem A Global Strategy to Boost Your Site’s Content Planning for the Post-Coronavirus Era Things To Consider When Choosing a Medical Career Subtle Effects of Interior Design into Our Emotions The Future of Car Charging Top 5 Government Contract Financing Options for You About guest posts on Science & Enterprise Please share Science & Enterprise Older Entries » FDA Authorizes Non-Prescription Covid-19 Test By Alan, on March 6th, 2021 Cue Covid-19 test. Click on image for full-size view (Cue Health Inc.) 6 Mar. 2021. Food and Drug Administration granted an emergency authorization for a molecular test for SARS-CoV-2 viruses done at home without a prescription. The FDA’s action authorizing the Cue Covid-19 Test by Cue Health Inc. in San Diego is the first clearance for an over-the-counter molecular test of viruses responsible for Covid-19 infections. The Cue Covid-19 Test uses mid-nose nasal swabs to collect a sample for analysis, rather than the deep nasopharyngeal swab used in professional RT-PCR tests that require a clinician. Adults can take swabs from their own nose or from children age two or more. The swab is inserted in a single-use test cartridge that amplifies RNA in the sample for analysis, with the cartridge then inserted into a cartridge reader. The reader returns results in about 20 minutes, displayed on a companion mobile app , available only for Apple iPhone 8 Plus or newer and iOS version 13 or higher. The company says an Android version of the app is in development. Cue Health tested its Covid-19 test in August 2020 at a Mayo Clinic drive-through testing facility in Mankato, Minnesota, with results published in the journal Diagnostic Microbiology and Infectious Disease . Some 292 individuals were randomly assigned for conventional RT-PCR testing or the Cue Health test. The results show positive tests for SARS-CoV-2 viruses with the Cue Health test matched RT-PCR tests 92 percent of the time, with negative tests from the Cue Health device matching RT-PCR results 98 percent of the time. The Cue Health test was first authorized by FDA for clinical use in June 2020, and the company says it’s now in use in doctors offices, hospitals, schools, businesses, dental clinics, and long-term care facilities. FDA says Cue Health plans to produce 100,000 tests by the summer of 2021. “For the first time,” says Ayub Khattak , co-founder and CEO of Cue Health in a company statement , “consumers can access laboratory-grade testing at home. This is an important milestone in the advancement of Covid-19 testing.” As reported by Science & Enterprise on 1 Mar., FDA authorized another home test for antigens indicating the presence of SARS-CoV-2 viruses, but requires a prescription. Quidel Corp., the company developing the test, says it plans to submit findings to FDA for clearance also as a home over-the-counter test. More from Science & Enterprise: Diagnostic Cleared for Covid-19, Other Diseases Tech Companies Partner on Covid-19 Breath Test FDA Issues Covid-19 Variant Regulatory Guidance Smartwatch Shown to Offer Early Covid-19 Warning U.S. Supports Home Smartphone Covid-19 Test * * * Leave a comment Regulations biomedical , clinical trials , Covid-19 , engineering , FDA , life sciences , medical device , software Two Therapies Dropped from NIH Covid-19 Trial By Alan, on March 5th, 2021 Scanning electron microscope image shows SARS-CoV-2 viruses emerging from the surface of cells cultured in the lab. (NIAID, NIH) 5 Mar. 2021. A clinical trial testing multiple treatments for people hospitalized with Covid-19 infections is dropping two therapies for not meeting efficacy standards. The Activ-3 trial sponsored by National Institute of Allergy and Infectious Diseases or NIAID, part of National Institutes of Health, removed from the trial synthetic antibody treatments made by Brii Biosciences in Durham, North Carolina and Beijing, and Vir Biotechnology in San Francisco. The trial is part of NIH’s Accelerating Covid-19 Therapeutic Interventions and Vaccines, or Activ , program to streamline and coordinate actions to combat the Covid-19 pandemic among agencies in the U.S. government, private pharmaceutical and biotech companies, international agencies, and not-for-profit groups. Among Activ’s goals is to accelerate evaluation of vaccine and therapy candidates to speed regulatory approval, including clinical trials of experimental drugs. Activ-3 is enrolling 10,000 participants at 78 sites worldwide hospitalized with Covid-19 disease, to test safety and efficacy of several therapies. The trial uses an adaptive design that allows for changing the course of the study while underway, without compromising gold-standard quality of the efficacy or safety data. Adaptive trials are usually governed by a single governing board and master protocol spelling out ground rules for the study, including standards and processes for assessing results, adding or closing sample groups, and adding new drugs or devices for testing. As reported by Science & Enterprise in December 2020, Activ-3 under its master protocol, added a combination of two synthetic antibodies made by Brii Bio, code-named BRII-196 and BRII-198 , designed to neutralize SARS-CoV-2 viruses, while reducing the risk of antibody-dependent enhancement, an unintended consequence that makes it easier for the original viruses to infect cells. The study also added Vir Biotech’s synthetic antibody code-named VIR-7831 , licensed to drug maker GlaxoSmithKline. Vir Biotech creates synthetic antibodies that work like natural, but often rare, antibodies produced by people who recover from infections, in this case from SARS-CoV-2 viruses responsible for Covid-19. Not meeting pre-defined efficacy criteria Brii Bio says in a statement that Activ-3’s independent data and safety monitoring board reviewed the first phase of data from 343 participants randomized to receive either the BRII-196/BRII-198 combination or a placebo. The board found findings from these participants on five ordinal rating scales i...