Cepheid with its newly introduced PCRplus-based Xpert coronavirus tests is well equipped for detection of the “Omicron” B.1.1.529 variant.
Based in Sunnyvale, California, Cepheid is a leading molecular diagnostics company dedicated to improving healthcare by developing, manufacturing, and marketing accurate yet easy-to-use molecular systems and tests.
Cepheid actively monitors COVID-19 virus mutations and its PCRplus is an elevated PCR test category reserved for molecular diagnostic testing solutions that deliver uncompromised accuracy, speed, flexibility, simplicity and exceptional test design expertise.
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 upon in-silico (computer-based) analysis.
The US Food & Drug Administration (FDA) granted Emergency Use Authorization (EUA) to Cepheid in September 2021 for its PCRplus-based Xpert CoV-2/Flu/RSV plus multiplex test for the viruses that cause COVID-19, influenza, and RSV infections.
Cepheid’s CoV-2 tests, designed with multiple gene targets to ensure comprehensive virus detection, have proven to be robust and reliable over time. This test design approach is used in all of Cepheid’s Xpert CoV-2 tests to help guard against variants and ensure the test performance healthcare providers have come to rely on.
“RNA viruses are well known to naturally undergo genetic variation, and thus are well poised to emerge in the face of new selective pressures — it is how they thrive,” said David Persing, M.D., Ph.D., EVP, and Chief Medical and Scientific Officer, Cepheid.
“From the beginning of the pandemic, we have been keenly focused on staying ahead of SARS-CoV-2 genetic drift and have designed our tests in anticipation of variants like Omicron and potential future variants,” he added.
Cepheid’s most recent test, Xpert Xpress CoV-2/Flu/RSV plus, is designed to include a more robust three-gene detection of SARS-CoV-2, enabling even more confident virus variant detection, further mitigating the possible effects of viral mutations.
These tests have has not been FDA cleared or approved. They have been authorized by the FDA under an EUA for use by authorized laboratories. Xpert Xpress SARS-CoV-2 has been authorized only for the detection of nucleic acid 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 have been authorized only for the simultaneous qualitative detection and differentiation of nucleic acid from SARS-CoV-2, influenza A virus, influenza B virus, and RSV and not for any other viruses or pathogens.
The tests are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.