Cepheid actively monitors for COVID-19 virus mutations and its PCRplus is an elevated PCR class of testing intended for molecular diagnostic testing solutions.

Cepheid, PCRplus-based Xpert Virus Tests, Omicron Variant, Molecular DiagnosticsThe FDA granted Emergency Use Authorization (EUA) to Cepheid in September 2021 for a PCRplus-based Xpert CoV-2/Flu/RSV test as well as a multiplex test for viruses that cause COVID-19, influenza, and RSV infections. .

Cepheid with the newly introduced PCRplus-based Xpert coronavirus tests are well equipped to detect the ‘Omicron’ variant B.1.1.529.

Cepheid is a leading molecular diagnostics company, headquartered in Sunnyvale, California, dedicated to improving healthcare through the development, manufacturing and marketing of accurate, easy-to-use molecular testing systems and tests.

Cepheid actively monitors for COVID-19 virus mutations and PCRplus is an elevated PCR test category dedicated to molecular diagnostic test solutions that offer exceptional accuracy, speed, flexibility, simplicity and expertise in test design.

The Xpert Xpress SARS-CoV-2, Xpert Xpress SARS-CoV-2/Flu/RSV and Xpert Xpress CoV-2/Flu/RSV plus tests all appear to be unaffected by this newly emerging variant, based on in-silico (computer-based) ) analysis.

The FDA granted Emergency Use Authorization (EUA) to Cepheid in September 2021 for a PCRplus-based Xpert CoV-2/Flu/RSV test as well as a multiplex test for viruses that cause COVID-19, influenza, and RSV infections. .

Cepheid’s CoV-2 tests, designed with multiple genetic targets to ensure comprehensive virus detection, have proven robust and reliable over time. This test design approach is used on all Cepheid’s Xpert CoV-2 tests to help protect against variants and ensure health care providers are reliant on test performance.

said David Persing, MD, Ph.D. , EVP, Chief Medical Officer and Scientific Officer will benefit.

“Since the beginning of the epidemic, we have focused heavily on staying ahead of the SARS-CoV-2 genetic drift and tailored our tests in anticipation of the presence of variants such as Omicron and potential future variants,” he added.

Cepheid’s latest assay, Xpert Xpress CoV-2/Flu/RSV plus, is designed to include a more robust three-gene detection of SARS-CoV-2, enabling more confident viral variant detection, mitigating the potential effects of viral mutations.

These tests have not been approved or approved by the Food and Drug Administration. It is licensed by the US Food and Drug Administration (FDA) under the European Union Agreement (EUA) for use by approved laboratories. Xpert Xpress SARS-CoV-2 is licensed only for the detection of DNA from SARS-CoV-2, and not for any other viruses or pathogens.

Xpert Xpress SARS-CoV-2/Flu/RSV and Xpert Xpress CoV-2/Flu/RSV plus are licensed only for simultaneous qualitative detection and differentiation of DNA from SARS-CoV-2, influenza A virus and influenza B virus, RSV and not for any viruses or other pathogens.

Tests are permitted only for the duration of the declaration that there are circumstances that justify authorizing the emergency use of in vitro diagnostic tests for the detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 USC § 360bbb-3(b)(1), Unless the authorization is terminated or revoked sooner.

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