Therapy Areas: Devices
Novacyt wins UK approval of new COVID-19 PCR test
15 July 2022 -

Clinical diagnostics company Novacyt (Euronext Growth:ALNOV) (AIM:NCYT) announced on Friday that its exsig COVID-19 Direct Real-Time PCR test has been approved in the UK.

The new test was approved 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. It removes the need for manual or automated extraction solutions, which Novacyt said could significantly improve laboratory workflow and reduce costs.

Additionally, 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.

This is Novacyt's fifth PCR product to be added to the CTDA register of approved products.

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