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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Gates-Backed At-Home COVID-19 Testing Program

(Reuters) – An at-home coronavirus testing project in Seattle backed in part by the Bill and Melinda Gates Foundation said on Saturday it was working with U.S. regulators to resume the program after being suspended by the Food and Drug Administration. The Seattle Coronavirus Assessment Network (SCAN), which aims to monitor the spread of the…

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Fluxergy Announces $30 Million to Expand Manufacturing Capacity of Its One-hour Point-of-care Diagnostic Testing System in Response to COVID-19

IRVINE, California, May 13, 2020 /PRNewswire/ — Irvine, California-based Fluxergy LLC, a diagnostic test company, is making a $30 million investment to expand its capability to scale production of the Fluxergy Analyzer diagnostic testing system in response to the COVID-19 pandemic. The Fluxergy system, utilizing state-of-the-art PCR and microfluidics technology, has been shown to accurately identify the SARS-CoV-2 virus in one…

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FDA Grants Emergency Use Authorization for Rutgers’ At-Home COVID-19 Saliva Test

Published: May 08, 2020 By Alex Keown Rutgers’ RUCDR Infinite Biologics received an amended Emergency Use Authorization from the U.S. Food and Drug Administration (FDA) for the first SARS-CoV-2 coronavirus test that will allow people to collect their own saliva at home and send to a lab for results. The new at-home saliva self-collection assay, developed by RUCDR in partnership with Utah-based Spectrum Solutions…

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Profile of a Killer: The Complex Biology Powering the Coronavirus Pandemic

Scientists are piecing together how SARS-CoV-2 operates, where it came from and what it might do next — but pressing questions remain about the source of COVID-19. Nature 581, 22-26 (2020) doi: 10.1038/d41586-020-01315-7 PDF version In 1912, German veterinarians puzzled over the case of a feverish cat with an enormously swollen belly. That is now…

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Vela Diagnostics Coronavirus RT-PCR Test Provisionally Authorized by Singapore Regulator

Vela Diagnostics said on Thursday it has received provisional authorization from Singapore’s Health Sciences Authority for the firm’s ViroKey SARS-CoV-2 RT-PCR Test. As a result, Vela can offer the test to healthcare institutes, private hospitals, medical clinics, and clinical laboratories licensed in Singapore. The test is a probe-based reverse transcription PCR test for detecting the…

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