NowSight: New Approvals in the United Kingdom

NovaSight announced that the ProMet Covid-19 2G real-time PCR test has been approved in the UK under the provisions of the UK Health Safety Agency Medical Devices Regulation 2021 (Coronavirus Test Device Approval – CTDA). The PROmate Covid-19 2G test is the first direct PCR product to be added to the CTDA’s Register of Approved Products. It is designed to detect the two targets of SARS-CoV-2 within ORF1ab in response to the increasing shift from single gene screening solutions to multigene solutions.

Direct PCR products eliminate complex manual or automated extraction solutions and are designed to dramatically improve laboratory workflows and reduce costs. Thanks to their simplicity and ease of use, they allow testing to be performed outside of traditional laboratories as well. Hence, PROmate Covid-19 2G PCR Test is well suited for industries like travel, sports, film, media and workplaces. The validation of the Promate Covid-19 2G test follows the UK’s acceptance of the company’s Covid-19 GeneSig real-time PCR test under the CTDA, as announced on 26 November 2021. Additionally, as previously announced, Novacyt’s PROmate Covid-19 1G real-time PCR test, currently supplied to the NHS under a National Microbiology Framework, is on the tentative protocol list (to expire on 28 February 2022). and the group awaits new information on seven other CTDA-submitted products in their Covid testing. Department.

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About the Author: Forrest Morton

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