(CercleFinance.com) – Novacyt announces the approval of its genesig® COVID-19 3G real-time PCR test in the UK under the UK Medical Device Safety Agency’s 2021 Regulations (Device Approvals). coronavirus test, amendment, ‘CTDA’). This makes the company’s seventh PCR test added to the CTDA registry of approved COVID-19 diagnostic products.
The genesig® COVID-19 3G test, CE marked April 2021, is designed to detect three distinct SARS-CoV-2 genetic targets (ORF1ab, M gene and S genes) from combined nasal and oropharyngeal specimens.
James McCarthy, Acting Group Chief Executive of Novacyt, said: ‘We believe that the ability of our 3G COVID-19 test to simultaneously target three distinct SARS-CoV-2 genes provides a highly accurate option for detection. This approval secures our good position with our consolidated COVID-19 portfolio to weather any future outbreaks as we continue to focus on broader offering as part of our growth strategy.’