First direct-to-PCR test added to the CTDA register of approved UK products

Novacyt – an international specialist in clinical diagnostics – has announced that the company’s PROmate COVID-19 2G Real-Time PCR test has been approved in the UK.

The PROmate COVID-19 2G test is the first direct-to-PCR product to be added to the CTDA register of approved products. It can detect two SARS-CoV-2 targets within ORF1ab in response to a shift from single-gene to multi-gene testing solutions.

Direct-to-PCR products are designed to improve laboratory workflow and cost effectiveness while also making testing processes simpler – replacing traditional, laboratory – based settings.

The approval 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. Novacyt’s PROmate COVID-19 1G Real-Time PCR test is currently being supplied to the NHS, under a national Microbiology Framework.

The Novacyt Group is an international diagnostics business generating an increasing portfolio of in vitro and molecular diagnostic tests. Alongside its global partners, the group directly serves microbiology, haematology and serology markets, which include major corporates.

David Allmond, group CEO of Novacyt, commented: “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,” he added.