Biotechnology company Novacyt has had it’s PROmate COVID-19 2G Real-Time PCR test approved in the UK.
The test, which is designed to detect two SARS-CoV-2 targets within ORF1ab is the first direct-to-PCR product to be added to the CTDA register of approved products in the UK where it has been approved under the UK Health Security Agency’s Medical Devices (Coronavirus Test Device Approvals) (Amendment) Regulations 2021 (CTDA).
David Allmond, Group CEO of Novacyt, said: “Our PROmate COVID-19 range offers a unique combination of workflow efficiency, results in as little as 80 minutes and exceptional clinical performance, optimised for both our genesig q16 and q32 instruments. It provides total viral inactivation, with a ready-prepared mix containing internal control for run validity, meaning there is no need for a category 2 laboratory to handle the live virus, thereby removing handling risk and bringing the test nearer to patients. With this approval from the CTDA, we can continue to meet the demand for high quality COVID-19 testing in the UK.”
Novacyt focuses on clinical diagnostics and has created the Direct-to-PCR test which means that testing doesn’t need to be done in traditional, laboratory-based settings and can be used in workplace settings, the travel industry and others such as sport, film and media. Direct-to-PCR products also reduce costs as they improve laboratory workflow.
The test is currently being supplied to the NHS under a National Microbiology Framework on the temporary protocol list which will expire on 28 February 2022.