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Emergency Use Authorization
FDA issues EUAs for 2 POC COVID-19 tests
By
LabPulse.com staff writers
The U.S. Food and Drug Administration (FDA) granted emergency use authorizations (EUAs) for two separate point-of-care (POC) assays for SARS-CoV-2 developed by Tangen Biosciences and SD Biosensor.
October 4, 2023
FDA awards EUA to Alphadera Labs’ COVID-19 test
By
Nick Paul Taylor
Alphadera Labs received the EUA after evaluating its test on 60 clinical nasopharyngeal swabs specimens. ALPHADx provided the same results as a “highly sensitive” FDA-authorized molecular SARS-CoV-2 test.
August 2, 2023
FDA authorizes Discover Labs to run molecular COVID-19 test at its Texas facility
By
Nick Paul Taylor
Under the terms of the EUA, Discover Labs can run the COVID-19 test at its CLIA-certified Austin facility. The test is for prescription use only.
July 7, 2023
Cue Health receives FDA emergency use authorization for molecular mpox test
By
Leo O'Connor
The test demonstrated high accuracy in clinical trials, achieving 100% concordance with the Center for Disease Control and Prevention’s (CDC's) mpox test on the samples tested, Cue Health said.
March 20, 2023
Mologic receives FDA EUA for at-home SARS-CoV-2 antigen test, eyes additional respiratory diseases
By
LabPulse.com staff writers
The development of the rapid antigen test was funded under an $11.8 million contract through the US National Institutes of Health (NIH) Rapid Acceleration of Diagnostics (RADx) initiative.
February 27, 2023
Lucira Health files for bankruptcy despite receiving FDA green light
By
Leo O'Connor
The firm is seeking a strategic or financial partner for the resumption of manufacturing and development of additional home diagnostic testing products.
February 27, 2023
FDA authorizes Lucira Health OTC test, the first to detect influenza and COVID-19 viruses
By
LabPulse.com staff writers
In people with symptoms, the Lucira COVID-19 & Flu Test correctly identified 99.3% of negative and 90.1% of positive influenza A samples; 100% of negative and 88.3% of positive COVID-19 samples; and 99.9% of negative influenza B samples, the FDA said.
February 24, 2023
FDA grants emergency use authorization for Anavasi LAMP-based COVID-19 test, detector
By
LabPulse.com staff writers
Anavasi said its point-of-care platform will enable the rapid development of tests to detect viral and bacterial targets, including influenza, respiratory syncytial virus (RSV), and sexual health-related strains, among others.
February 13, 2023
FDA authorizes Cepheid molecular test to detect monkeypox virus at the point of care
The Xpert Mpox test is a real-time polymerase chain reaction assay to detect Mpox virus DNA in lesion swab specimens from individuals suspected of monkeypox by their healthcare provider.
February 10, 2023
BD nabs FDA authorization for SARS-CoV-2, influenza A/B, RSV combination test
By
LabPulse.com staff writers
The test uses a single nasal or nasopharyngeal swab sample to identify and distinguish whether a patient has COVID-19, the flu, RSV, or some combination of the three, with results available in two hours.
February 8, 2023
LumiraDx obtains FDA authorization for test to detect flu A, flu B, SARS-CoV-2
By
LabPulse.com staff writers
The test leverages a single-step direct method for nucleic acid extraction and amplification on validated open RT-PCR instruments.
February 7, 2023
Lucira Health applies for FDA Emergency Use Authorization of over-the-counter COVID-19, flu A, flu B molecular test
By
LabPulse.com staff writers
The single-use test fits in the palm of the hand, runs on two AA batteries, and with one shallow nasal swab provides a positive or negative result for COVID-19, flu A, or flu B in less than 30 minutes.
January 3, 2023
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