Coronavirus company news summary - Seegene gets CE-IVD Mark for Combo Swab self-collection device - SpeeDx to supply molecular assay in UK - Verdict Medical Devices
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Coronavirus company news summary – Seegene gets CE-IVD Mark for Combo Swab self-collection device – SpeeDx to supply molecular assay in UK

02 Sep 2021

South Korean diagnostics firm Seegene has secured CE-IVD Mark for its Combo Swab self-collection device with four diagnostic assays. The swab is intended for at-scale sample collection, enabling patients to easily obtain samples from the nasal and oral cavities under a healthcare professional’s supervision. With the CE Marking, Combo Swab can be used with Seegene’s Allplex SARS-CoV-2 Assay, Allplex SARS-CoV-2 Master Assay, Allplex SARS-CoV-2 Variants I Assay and Allplex SARS-CoV-2/FluA/FluB/RSV Assay.

Quidel is set to offer its non-prescription QuickVue At-Home OTC COVID-19 Test for customers at more than 7,000 CVS Pharmacy locations in the US and the retailer’s online store, beginning next week. One pack of the test will comprise two rapid antigen self-tests. The move is intended to meet the increased customer demand for the test, Quidel said. The company aims to achieve a target run-rate capacity of nearly 70 million rapid antigen Covid-19 tests a month by the end of 2021.

SpeeDx has become part of the new Public Health England (PHE) National Microbiology Framework to provide diagnostic goods and services in the UK. Under the framework’s Lot 1, SpeeDx will enable non-exclusive access to its in-vitro diagnostics and related services to participating public health authorities. The company’s offerings involve a dual-target molecular assay for Covid-19, called PlexPCR SARS-COV-2.