Novacyt gets another Covid-19 test approved in the UK
Clinical diagnostics company Novacyt announced on Thursday that its ‘PROmate’ Covid-19 2G Real-Time PCR test had been approved in the UK, under the UK Health Security Agency's coronavirus test device approvals (CTDA) regulations.
The AIM-traded firm said the PROmate test was the first direct-to-PCR product to be added to the CTDA register of approved products, and was designed to detect two SARS-CoV-2 targets in response to an “increasing shift” from single-gene to multi-gene testing solutions.
It explained that direct-to-PCR products removed the need for complex, manual or automated extraction solutions, and were designed to “significantly improve” laboratory workflow and reduce costs.
The process also allowed testing to take place away from traditional, laboratory-based settings, due to simplicity and ease-of-use.
Thus, the PROmate test was “well-suited” for industries such as travel, sport, film, media, and workplace settings.
The company noted that the validation of the PROmate test followed the UK approval of its ‘genesig’ real-time PCR test under the CTDA, as announced in late November.
In addition, the PROmate Covid-19 1G real-time PCR test, currently being supplied to the NHS under a National Microbiology Framework, remained on the temporary protocol list as the company awaited further updates on an additional seven products submitted to the CTDA across its Covid-19 testing portfolio.
“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,” said chief executive officer David Allmond.
“It provides total viral inactivation, with a ready-prepared mix containing internal control for run validity, meaning there is no need for a category two 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.”
At 1512 GMT, shares in Novacyt were up 0.36% at 196.3p.