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Infectious
Influenza: Page 2
Cue Health requests FDA de novo clearance for at-home flu test
Clearance would permit the test to be used at home and elsewhere at the point-of-care (POC).
September 1, 2022
Hologic launches respiratory assays in Europe
Both products are compliant with the European In Vitro Diagnostic Medical Device Directive (IVDD) and are being made available in time for the Northern Hemisphere's respiratory viral season, the firm said.
July 10, 2022
BD nabs CE Mark for respiratory viral panel
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
Seegene secures EU approval for SARS-CoV-2 assay
The clearance will allow Seegene to market the assay to small hospitals, local clinics, and public health centers for identification of COVID-19, influenza A and B, and respiratory syncytial virus (RSV).
June 28, 2022
FDA issues EUA for Labcorp NGS test to detect SARS-CoV-2 strains
The SARS-CoV-2 virus has mutated over time, resulting in multiple strains, also known as lineages.
June 12, 2022
CorDX obtains CE Mark for test for COVID-19, flu A/B, RSV
"As COVID-19 infection prevention measures relax globally, COVID and other viral infections are projected to rise," CorDx founder and CEO Jeff Yufeng Li said in a statement.
June 2, 2022
Seegene unveils strategy for $12 COVID-19 PCR tests
The company's "in-life PCR" initiative includes asymptomatic testing for early virus detection and syndromic respiratory testing, as well as boosting PCR test accessibility through affordable pricing.
May 24, 2022
LabPulse.com Microbiology Insider
Dear Microbiology Insider,
May 17, 2022
Visby awarded $25M to develop combined flu-COVID test
The funds were awarded by the U.S. Department of Health and Human Services' Biomedical Advanced Research and Development Authority (BARDA) and will support continued development of the test. As it is, the company's Flu-COVID PCR test is a single-use, handheld, and all-in-one PCR device that detects and distinguishes between influenza A, influenza B, and SARS-CoV-2 from one sample.
March 27, 2022
Visby raises $100M in financing
The funds will be used to scale production capacity from tens to hundreds of thousands of tests per month, to expand its product portfolio to include COVID plus influenza A/B combination testing and antimicrobial resistance panels, and to deliver PCR diagnostics to consumers at-home.
March 2, 2022
Roche adds SARS-CoV-2 tests to new Cobas 5800 systems
The expansion will see the Cobas SARS-CoV-2 Qualitative and Cobas SARS-CoV-2 and Influenza A/B tests included in the Cobas 5800 system, a recently launched molecular laboratory instrument.
February 23, 2022
DnaNudge launches 90-minute COVID test in Australia
CovidNudge is a point-of-care test platform that consists of the DnaCartridge, a disposable and sealed lab-on-chip device, and the NudgeBox, a standalone instrument that is connected to the DnaNudge Cloud for processing.
February 15, 2022
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