Emergency Use Authorization: Page 4

FDA issues alert on Ellume at-home COVID-19 tests
By LabPulse.com staff writers
The FDA said the incorrect results only occurred in certain lots of the Ellume COVID-19 Home Test, and that negative test results did not appear to be affected by the issue. The agency said it was working with Ellume on corrective steps to address the reason for the manufacturing issue and to resolve the problem.
October 4, 2021
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COVID-19 tests attempt to prove at-home testing concept can work
By Daniel Granderson
These COVID-19 tests were granted separate emergency use authorizations (EUAs) from the U.S. Food and Drug Administration (FDA) earlier in 2021 and all require nasal swab specimens from patients.
August 22, 2021
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Acupath to process PCR test for international travelers
By LabPulse.com staff writers
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
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PathogenDx nabs CE-IVD Mark for DetectX-Rv test
By LabPulse.com staff writers
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
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Quidel recalls Lyra SARS-CoV-2 assay due to false-negative tests
By LabPulse.com staff writers
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
By Brian Casey
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
By LabPulse.com staff writers
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
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Mologic lands NIH funding for COVID-19 rapid antigen self-test
By LabPulse.com staff writers
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
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Thermo Fisher to launch new qPCR system
By LabPulse.com staff writers
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
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FDA approves marketing of BioFire COVID-19 test
By LabPulse.com staff writers
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
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Vela Diagnostics adds 2 SARS-CoV-2 assays
By LabPulse.com staff writers
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
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FDA releases new guidance for developers of COVID-19 products
By LabPulse.com staff writers
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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