Novacyt, a clinical diagnostics specialist, has received approval for its exsig COVID-19 Direct Real-Time PCR test under the UK Health Security Agency’s Medical Devices (Coronavirus Test Device Approvals) (Amendment) Regulations 2021 (CTDA).
The exsig COVID-19 Direct Real-Time PCR test is designed to detect a SARS-CoV-2 gene target within ORF1ab and, as with all the company’s direct-to-PCR products, removes the need for manual or automated extraction solutions to significantly improve laboratory workflow and reduce costs.
The test is designed for use on an open platform, meaning it can be used with the company’s q16 and q32 instruments, as well as other validated systems. The test is the company’s fifth PCR product to be added to the CTDA register of approved products.
David Allmond, group CEO of Novacyt, said: “To ensure Novacyt is well positioned for any future COVID-19 outbreaks, the Company continues to consolidate its portfolio. The approval of exsig COVID-19 Direct supports this aim, complementing the company’s existing PCR portfolio for COVID-19 testing in the UK and further reinforcing Novacyt’s position as a first responder in infectious diseases.”