Emergency Use Authorization: Page 4

Acupath to process PCR test for international travelers
CLX manages the cloud-based TrustAssure platform, which is used by dozens of airlines globally and services more than 75 countries worldwide, Acupath said. The platform supports a network of healthcare providers providing COVID-19 PCR tests that satisfy entry requirements for international destinations. Using TrustAssure eliminates the need to be tested last minute at the airport, the company said.
August 4, 2021
2020 06 15 18 14 5259 Swab Sample Collection 400
PathogenDx nabs CE-IVD Mark for DetectX-Rv test
DetectX-Rv will now be available for sale and distribution to qualified laboratories across the European Union. DetectX-Rv's microarray utilizes nasopharyngeal swabs and nasal aspirate or fluid to detect SARS-CoV-2 within three hours after RNA extraction.
July 21, 2021
2021 02 25 23 48 3444 Covid Virus Dna Molecule 400
Quidel recalls Lyra SARS-CoV-2 assay due to false-negative tests
In a July 7 announcement, the FDA said that Quidel began the recall on April 26. The recall affects over 18,000 kits, with each kit containing 96 reactions.
July 6, 2021
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FDA puts kibosh on use of Innova Medical coronavirus test
In a June 10 notice, the FDA said it had "significant concerns" that the performance of Innova's SARS-CoV-2 Antigen Rapid Qualitative Test had not been proven in clinical studies. Also, the FDA noted that the test had not been authorized or cleared by the agency for commercial distribution in the U.S.
June 9, 2021
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Beckman Coulter launches new COVID-19 IgG test
The assay is traceable to the First World Health Organization (WHO) International Standard for anti-SARS-CoV-2 immunoglobulin (human) and reports results directly aligned with the binding antibody units/milliliter (BAU/mL) standard established by the WHO.
May 19, 2021
2019 08 09 22 20 6739 Beckman Coulter Aacc 2019 400
Mologic lands NIH funding for COVID-19 rapid antigen self-test
Intended for use by nonhealth professionals, the nasal swab test is designed to indicate the presence of SARS-CoV-2 nucleoprotein in approximately 20 minutes, according to the vendor. Mologic said it will now accelerate development and clinical validation of the COVID-19 self-test. It has also received guidance on how to achieve emergency use authorization from the U.S. Food and Drug Administration.
April 5, 2021
2021 02 25 23 48 3444 Covid Virus Dna Molecule 400
Thermo Fisher to launch new qPCR system
Clinical diagnostic and hospital laboratories across the U.S. have ramped up PCR testing over the last year in response to the global COVID-19 pandemic. These laboratories are now seeking solutions to continue to screen for COVID-19 after emergency use authorizations (EUAs) for SARS-CoV-2 assays expire.
March 24, 2021
2020 05 07 22 15 9104 Thermo Fisher Scientific 400
FDA approves marketing of BioFire COVID-19 test
The diagnostic test had emergency use authorization and received approval for marketing through the FDA's "de novo" pathway, a regulatory pathway for low- to moderate-risk devices of a new type. The de novo request was based on additional data showing validation beyond what is needed for emergency use authorization.
March 17, 2021
2020 07 16 23 29 1615 Laboratory Scientist Biosafety 400
Vela Diagnostics adds 2 SARS-CoV-2 assays
The genotyping assay uses next-generation sequencing (NGS) to sequence the entire SARS-CoV-2 genome in less than two hours, the company said. The accompanying Sentosa SQ Reporter software then calls out mutations and classifies them by lineage, aiding research into and understanding of the novel coronavirus.
February 25, 2021
2020 05 08 21 55 4265 2020 03 12 Sars Co V 2 400
FDA releases new guidance for developers of COVID-19 products
Among other documents, the agency has issued a policy for evaluating impact of viral mutations, which explains the effect of variants on test performance, due to a number of factors including the type of variant and test design. The guidance document provides instruction for test developers on how to design products with variants in mind and to monitor performance over time as new mutations of the virus emerge.
February 22, 2021
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Molecular Designs creates PCR test for COVID-19 variant
To detect the variant, labs must sequence the viral genome from positive SARS-CoV-2 tests but the process is expensive and slow, the firm said. The new test targets four signature mutations in the variant, and Assurance Scientific Laboratories is currently validating the test for clinical use. If all goes according to plan, Assurance will fill for authorization under its existing U.S. Food and Drug Administration emergency use authorization.
February 21, 2021
2020 11 11 22 30 8321 3d Closeup Coronavirus 400
Luminex receives $11.3M from BARDA for multiplex assay
The panel will be able to run on all Aries 6- and 12-cassette systems. Results will be available in less than two hours, the firm said. BARDA is part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services.
February 18, 2021
2021 01 12 23 44 3780 Blood Test Samples Lab 400
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