Novacyt announced that the Company's PROmate® COVID-19 2G 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 2G test is the first direct-to-PCR product to be added to the CTDA register of approved products and is designed to detect two SARS-CoV-2 targets within ORF1ab in response to an increasing shift from single-gene to multi-gene testing solutions. Direct-to-PCR products remove the need for complex, manual or automated extraction solutions and are designed to significantly improve laboratory workflow and reduce costs.

It also allows testing to take place away from traditional, laboratory-based settings due to simplicity and ease of use. Therefore, the PROmate® COVID-19 2G PCR test is well suited for industries such as travel, sport, film, media, and workplace settings. The validation of the PROmate® COVID-19 2G test follows the UK approval of the Company's COVID-19 genesig® Real-Time PCR test under the CTDA, as announced on 26 November 2021.

In addition, as previously announced, Novacyt's PROmate® COVID-19 1G Real-Time PCR test, currently being supplied to the NHS under a National Microbiology Framework, remains on the temporary protocol list (due to expire on 28 February 2022) and the Company awaits further updates on an additional seven products submitted to the CTDA across its COVID-19 testing portfolio.