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November 3, 2021

Coronavirus company news summary – Qiagen’s multiplex test obtains CE mark for Covid-19, flu and RSV detection – Avacta and Novacyt withdraw supply of some Covid-19 tests in the UK

By Chloe Kent

Qiagen has obtained a CE mark for its QIAstat-Dx Respiratory 4 Plex Flu A-B/RSV/SARS-CoV-2 test, which is intended to be used on the QIAstat-Dx system. The newly launched polymerase chain reaction (PCR) multiplex test can rapidly detect and distinguish between influenza A and B, respiratory syncytial virus (RSV) and Covid-19 infections. Using the simple QIAstat-Dx modular cartridge-based system, the test provides rapid results in nearly one hour without needing further preparation of the sample.

Avacta and Novacyt have suspended the marketing of certain Covid-19 tests in the UK following the Medical Devices (Coronavirus Test Device Approvals) (Amendment) Regulations 2021 of the UK Health Security Agency coming into effect. Avacta has halted the sales of its AffiDX SARS-CoV-2 Lateral Flow Rapid Antigen Test in the country until the agency concludes the desktop evaluation. Novacyt will now only market its PROmate COVID-19 test while the authority reviews its other nine tests.

Semiconductor supplier Renesas Electronics has ramped up production of a synchronous boost converter solution used with Lucira Health’s at-home Covid-19 test, due to anticipated high demand. The single-use Lucira COVID-19 All-In-One Test Kit obtained Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) in November last year. It has a ‘swab, stir and detect’ design to deliver a positive or negative result in the at-home setting in just 30 minutes.

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