Emergency Use Authorization: Page 2

Visby Medical receives FDA Emergency Use Authorization for respiratory test in CLIA-waived settings
By LabPulse.com staff writers
The Respiratory Health Test is a rapid PCR device that detects and differentiates upper respiratory infections caused by influenza A & B and SARS-CoV-2.
January 3, 2023
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CorDx receives FDA Emergency Use Authorization for COVID-19 antigen test
By LabPulse.com staff writers
The COVID-19 Ag lateral flow immunoassay provides qualitative detection of the nucleocapsid protein antigen from the SARS-CoV-2 virus, providing a result in 10 minutes.
December 1, 2022
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Roche obtains FDA authorization for monkeypox test on high-throughput MDx system
By LabPulse.com staff writers
Roche's Cobas MPXV test targets two different regions of the MPXV genome which are both less prone to mutations than other parts of the genome, the firm said.
November 16, 2022
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BD, CerTest launch monkeypox assay for global and U.S. markets
By LabPulse.com staff writers
The companies used the BD Max System open-architecture reagent suite to develop the CerTest Viasure Monkeypox molecular assay. The assay comes in a lyophilized format and in the form of a tube that snaps into the test-specific position on the BD Max ExK TNA extraction strip supplied by BD, the companies said.
September 25, 2022
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OIG: FDA recommendations for future pandemics
By Leo O'Connor
OIG offered numerous recommendations to manage such infectious disease emergencies, saying the FDA should access and, when appropriate, revise its guidance for Emergency Use Authorization (EUA) submissions for tests.
September 21, 2022
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FDA issues monkeypox testing guidance, first EUA to Quest
By Leo O'Connor
The agency issued guidance that outlines its views regarding enforcement policies, recommendations for emergency use authorization (EUA) requests for monkeypox diagnostic tests, and plans to prioritize review of EUA requests.
September 6, 2022
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Nanomix, Mobility to develop COVID-19 antibody POC test
By LabPulse.com staff writers
Under the agreement, Nanomix would supply the product elements and Mobility Health would complete development and validation of the test.
September 1, 2022
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Mylab and Hemex launch new COVID-19 test
By LabPulse.com staff writers
The lateral flow test is the result of a collaborative effort to develop COVID-19 point-of-care testing in India.
July 6, 2022
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BD nabs CE Mark for respiratory viral panel
By LabPulse.com staff writers
The panel, a molecular diagnostic combination test for SARS-CoV-2, influenza A + B, and respiratory syncytial virus (RSV), uses a nasal swab or nasopharyngeal swab sample.
June 30, 2022
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Cue Health seeks full FDA nod for molecular COVID-19 test
By LabPulse.com staff writers
The test, which received emergency use authorization from the FDA in June 2020, has been used by millions of Americans and by healthcare institutions such as Johns Hopkins Medicine, Mayo Clinic, Memorial Hermann, and UPMC Children's Hospital of Pittsburgh, according to Cue.
May 3, 2022
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Truvian appoints four top executives
By LabPulse.com staff writers
Truvian has appointed Ajay Bansal as chief financial officer, Tyler Jensen as chief product officer, Joe Benson as vice president of strategy and portfolio management, and Eric Zieger as vice president of global sales.
April 20, 2022
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KSL launches COVID-19 immunity test
By LabPulse.com staff writers
KSL's COVID-19 immune index can help monitor effectiveness of COVID-19 virus protection through a simple blood test. The test allows patients to understand their immune status so they can better time booster vaccines.
April 5, 2022
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