First Over-the-Counter Covid-19 Test Gets FDA Clearance

The U.S. Food and Drug Administration on Tuesday authorized a Covid-19 test that can be administered and processed at home, the first such test allowed to be sold over-the-counter at drugstores or other retail locations without a prescription. The antigen test, made by Ellume USA LLC, is a single-use, disposable test that searches for pieces…

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Streck Cell-Free DNA BCT® Receives U.S. FDA De Novo Clearance

LA VISTA, Neb., Sept. 11, 2020 /PRNewswire/ — Streck Cell-Free DNA BCT received U.S. Food and Drug Administration De Novo clearance for In Vitro Diagnostic use when paired with the Guardant360 CDx liquid biopsy assay. Cell-Free DNA BCT is the first and only circulating nucleic acid first blood collection tube to be cleared for use…

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COVID-19 Is Transmitted Through Aerosols. We Have Enough Evidence, Now It Is Time to Act

Many months into the COVID-19 pandemic, the coronavirus is still spreading uncontrolled through the U.S. Public health authorities including the U.S. Centers for Disease Control and Prevention (CDC) and the World Health Organization (WHO) tell us to remain six feet apart, wash our hands, disinfect frequently touched surfaces, and wear masks. But compliance with these measures—especially masks—is mixed, and…

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People with Hidden Immunity Against Covid-19

BBC.Com 19-July-2020. While the latest research suggests that antibodies against Covid-19 could be lost in just three months, a new hope has appeared on the horizon: the enigmatic T cell.T The clues have been mounting for a while. First, scientists discovered patients who had recovered from infection with Covid-19, but mysteriously didn’t have any antibodies against…

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U.S. FDA OKs Testing of Pooled Samples for COVID-19

The U.S. Food and Drug Administration on 19 July approved testing pooled batches of samples for the COVID-19 virus, a strategy supporters say could help screen more people faster and at less cost than through individual tests. The strategy saves reagents by combining samples from four people and running a single test. If the batch…

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Moderna’s COVID-19 Vaccine Shows Early Promise in Phase I Trial

Jul 15, 2020 By Mark Terry (BioSpace) – In mid-May, Moderna released positive interim data from its Phase I trial of mRNA-1273, its mRNA vaccine against SARS-CoV-2, the virus that causes COVID-19. It was in a press release and although the company shares rocketed, critics immediately took aim at what they felt was a lack…

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Could a Blood ‘Observatory’ Stop Pandemics?

By Robert Bazell – Science 26 Jun 2020: Vol. 368, Issue 6498, pp. 1413. Michael Mina is out for blood—millions of samples, which a nascent effort dubbed the Global Immunological Observatory (GIO) would monitor for signs of pathogens spreading through the population. Instead of a telescope, it will rely on technology that can measure hundreds…

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BioGX and Bosch Healthcare Solutions Announce Partnership to Develop Infectious Disease Tests for the Vivalytic Platform

BIRMINGHAM, Ala. and STUTTGART, Germany, May 26, 2020 /PRNewswire/ — BioGX and Bosch Healthcare Solutions have partnered to develop point-of-care infectious disease tests for the Bosch Vivalytic all-in-one platform. Vivalytic is a universal sample-to-result platform for molecular diagnostics which can be used at the point-of-need. The patient sample is placed into the test cartridge, which…

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F.D.A. Clears Everlywell Coronavirus Testing Kit for Use at Home

The agency granted emergency clearance for a testing kit that allows a consumer to take a nasal sample at home and send it to a laboratory for the diagnosis. The Food and Drug Administration on Saturday granted emergency clearance for a coronavirus testing kit that will enable individuals to take a nasal sample at home…

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