Novacyt’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 and Coronavirus Test Device Approvals Regulations 2021.
The PROmate COVID-19 1G test is designed to detect a SARS-CoV-2 gene target within ORF1ab and – as with all of the company’s direct-to-PCR products – removes the need for complex, manual or automated extraction solutions to accelerate laboratory workflow and reduce costs.
The test is Novacyt’s second direct-to-PCR test and the third product to be added to the CTDA register of approved products. It was previously on the CTDA Temporary Protocol list of products which can continue to be sold in the UK while seeking validation.
David Allmond, group CEO of Novacyt, commented: “Providing total viral inactivation without the need for a category 2 laboratory to handle the live virus, our PROmate tests reduce handling risk and help bring testing nearer to patients. We look forward to continuing to meet the demand for high quality COVID-19 testing in the UK, as well as leveraging our direct-to-PCR technology for new disease targets in future.”
Novacyt is currently awaiting further updates on five other products submitted to the Coronavirus Test Device Approvals across its COVID-19 testing portfolio. Throughout the pandemic, the company produced a significant number of lateral flow and PCR tests for use in many countries across the world.
