Today, the clinical diagnostics specialist, Novacyt (NCYT ), and the molecular diagnostic group,Yourgene Health (YGEN , both received approvals in the UK under the UK Health Security Agency’s Medical Devices (Coronavirus Test Device Approvals) 2021 regulations. 

Novacyt, a diagnostics firm that develops in vitro and molecular diagnostic tests, announced that its PROmate® COVID-19 2G real-time PCR test has been approved in the UK, making it the first direct-to-PCR product to be added to the CTDA’s register of approved products.

Novacyt’s PROmate® test is designed to detect two SARS-CoV-2 targets within the ORF1ab gene 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.

The product also allows testing to take place away from traditional, laboratory-based settings due to simplicity and ease of use. Therefore, Novacyt believes 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® 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.

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.

Since thai is due to expire by the end of the month, the Company is awaiting further updates on an additional seven products submitted to the CTDA across its COVID-19 testing portfolio.

Commenting, David Allmond, Group CEO of Novacyt, stated: “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.”

Meanwhile, Yourgene also announced this morning that it has received confirmation from the UK Health Security Agency that the Clarigene® SARS-CoV-2 test has received UK approval.

The company said the product is expected to be included on CTDA’s register of products that have been approved under 38A(5) of the Medical Devices Regulations 2002 ‘in due course’. 

Yourgene told investors that its primary source of COVID-19 revenues, PCR testing and sequencing services, has remained unaffected by the extended time taken to receive this approval under these newly introduced UK regulations ‘because they were not reliant on selling Clarigene® or Clarigene® achieving approval under CTDA regulations,’ it explained.

Following today’s approval from the CTADA, Yourgene can now actively market the Clarigene® test to new UK customers to meet the needs of continued seasonal PCR testing. 

The company highlighted that the Clarigene® test  will be one of a small number of UK manufacturers with COVID-19 testing products currently approved for sale in the UK.

Follow News & Updates from Novacyt here:  and Yourgene Health here: