Tag: <span>FDA</span>

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Roche develops new COVID-19 antibody test

Roche has announced it is developing a new serology test to detect COVID-19 antibodies, with a planned launch date in early May. The Elecsys Anti-SARS-CoV-2 immunoassay is an in vitro test, using human serum and plasma drawn from a blood sample, to detect antibodies and determine the body’s immune reaction to SARS-CoV-2. The test may...

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Abbott launches COVID-19 antibody test

Abbott has launched its third test for coronavirus (COVID-19) and will start shipping it in the U.S. The test is a serology test ―also called an antibody test―, which could be a critical next step in battling this virus. Abbott’s test helps to detect the IgG antibody to SARS-CoV-2. An antibody is a protein that...

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Siemens developing new diagnostic for COVID-19

The Erlangen, Germany-based company said its Fast Track Diagnostics (FTD) SARS-COV-2 Assay is already being shipped in Europe for research use only. Siemens Healthineers is looking at speaking with FDA to release the test under Emergency Use Authorization. Siemens Healthineers is adding more firepower in the fight to make more novel coronavirus (SARS-CoV-2) diagnostics available....

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Cepheid molecular test for the qualitative detection of SARS-CoV-2

Cepheid has developed an automated molecular test for the qualitative detection of SARS-CoV-2, the virus that causes COVID-19. The test leverages the design principles of Cepheid current Xpert® Xpress Flu/RSV cartridge technology, in which multiple regions of the viral genome are targeted. The test can provide rapid detection of the current pandemic coronavirus SARS-CoV-2 in...

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Hologic’s molecular test for SARS-CoV-2 receives FDA Emergency Use Authorization

Hologic, Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for the Company’s new Panther Fusion® SARS-CoV-2 assay, a molecular diagnostic test that detects SARS-CoV-2, the virus that causes COVID-19 disease. Hospital, public health and reference laboratories can perform the test on Hologic’s Panther Fusion system, a...