GBC Blog

Emergency Use Application (EUA) Follows Completion of Test Validation with Patient Samples by Physician-Scientists at UC San Diego

IRVINE, Calif., March 30, 2020 /PRNewswire/ — Fluxergy LLC, a research and medical diagnostic test company based in Irvine California, has submitted an Emergency Use Authorization (EUA) request to the U.S. Food and Drug Administration (FDA) Center For Devices and Radiological Health, seeking an authorization that would permit medical professionals to begin using the company’s high-speed Research Use Only…

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Vela Diagnostics to Offer ViroKey™ SARS-CoV-2 RT-PCR Test After Completion of Emergency Use Authorization (EUA) Validation

SINGAPORE, March 29, 2020 /PRNewswire/ — Ahead of Emergency Use Authorization (EUA) and in accordance with the U.S. Food and Drug Administration (FDA) Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency guidance document issued on March 16, 2020, Vela Diagnostics will offer the manual ViroKey™ SARS-CoV-2 RT-PCR Test when validation is…

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Randox and Bosch to Launch Game-Changing Vivalytic Point of Care (POC) Coronavirus Test

By HospiMedica International – 28 Mar 2020.Global diagnostics company Randox Laboratories (Crumlin, UK) and leading technology manufacturer Bosch Healthcare Solutions GmbH (Waiblingen, Germany) will launch a game-changing point of care coronavirus test in April 2020. The Vivalytic Viral Respiratory Tract Infection (VRI) Array can identify SARS-CoV-2 (COVID-19) and differentiate it from nine other respiratory infections…

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GenomicTree to Export COVID-19 Diagnostic Kit to USA

GenomicTree said that it would start the shipment of its COVID-19 molecular diagnostic kit to Los Angeles, CA. Currently, the U.S. permits COVID-19 molecular diagnostic products to enter its market through two channels – the Food and Drug Administration’s “Emergency Use Authorization (EUA) system,” and the verification procedures of the state-managed Clinical Laboratory Improvement Amendments…

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Coronavirus Test Tracker: Commercially Available COVID-19 Diagnostic Tests

MaAs labs and diagnostic developers race to meet demand for assays to detect the SARS-CoV-2 coronavirus, 360Dx is updating this tracker on a regular basis in order to provide readers with up-to-date and accurate information on the regulatory status of these tests in the US, European, and Asian markets. The tracker includes only those tests…

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BioMérieux Receives Emergency Use Authorization for BIOFIRE® COVID-19 Test

March 24, 2020 MARCY L’ÉTOILE, France–(BUSINESS WIRE)–Regulatory bioMérieux (Paris:BIM), a world leader in the field of in vitro diagnostics, today announced that its subsidiary, BioFire Defense, has received Emergency Use Authorization by the U.S. Food and Drug Administration of its BIOFIRE® COVID-19 test for use in CLIA moderate and high complexity clinical laboratories to detect…

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Researchers At UC San Diego Evaluating Potential “One-Hour” COVID-19 Diagnostic Test Developed By Irvine-Based Innovator Fluxergy

IRVINE, Calif., March 17, 2020 /PRNewswire/ — Physician-scientists at the University of California, San Diego (UCSD) are the first to evaluate a new diagnostic testing system designed by Irvine, CA-based Fluxergy, that holds promise for identifying the SARS-CoV-2 virus (also known as the novel coronavirus) in as little as 45 minutes and typically within one…

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First of 3 Diagnostic Tests for Coronavirus (COVID-19) Available from bioMérieux

Business Wire – March 10, 2020 – bioMérieux (Paris:BIM), a world leader in the field of in vitro diagnostics, is announcing the forthcoming launch of 3 different tests to address the COVID-19 epidemic and to meet the different needs of physicians and health authorities in the fight against this emerging infectious disease. bioMérieux has finalized…

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MicroRNA Signatures May Aid in Early Detection of Lung Cancer

March 11, 2020, Leah Lawrence – Researchers say they can distinguish between lesions that are benign and those that could become invasive — but the technology required is not yet used routinely. Testing only occurred among symptomatic patients. Circulating microDNA profiles may serve as a useful tool for lung cancer detection in symptomatic patients when…

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U.S. Coronavirus Testing Threatened by Shortage of Critical Lab Materials

By DAVID LIM and BRIANNA EHLEY 03/10/2020 06:56 PM EDT A looming shortage in lab materials is threatening to delay coronavirus test results and cause officials to undercount the number of Americans with the virus. The slow pace of coronavirus testing has created a major gap in the U.S. public health response. The latest problem…

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