Novacyt announced that the Company's PROmate® COVID-19 1G (q32) Real-Time PCR test has been approved in the UK under the UK Health Security Agency's Medical Devices (Coronavirus Test Device Approvals) (Amendment) Regulations 2021 ("CTDA"). The PROmate® COVID-19 1G test for use on Novacyt's q32 instrument is the Company's second direct-to-PCR and third product to be added to the CTDA register of approved products. The test is designed to detect a SARS-CoV-2 gene target within ORF1ab and, as with all the Company's direct-to-PCR products, removes the need for complex, manual, or automated extraction solutions to significantly improve laboratory workflow and reduce costs.

The test was previously on the CTDA Temporary Protocol list of products which can continue to be sold in the UK whilst validation is being processed. As previously announced, Novacyt's PROmate® COVID-19 1G test for use on the Company's q16 instrument (currently on the Temporary Protocol list) continues to be supplied to the NHS under a National Microbiology Framework.