Receive our newsletter – data, insights and analysis delivered to you
  1. Uncategorised
July 23, 2020

Coronavirus company news summary – Luminex submits EUA request for expanded NxTAG Respiratory Pathogen Panel – Megna Health secures EUA for Rapid COVID-19 IgG and IgM Combo Test Kit

By Chloe Kent

Luminex has submitted an Emergency Use Authorisation (EUA) request to the US Food and Drug Administration (FDA) for an expanded version of its NxTAG Respiratory Pathogen Panel (RPP) to now include the SARS-CoV-2 virus for high-throughput testing of Covid-19. The new test is a mix of the firm’s original NxTAG RPP, an FDA-cleared in vitro diagnostic for syndromic respiratory infection testing and the circulating pathogen today, SARS-CoV-2.

Avacta Group has commenced work with the UK government’s COVID-19 National Diagnostic Research and Evaluation Platform (CONDOR) programme to analyse and clinically validate the high throughput Covid-19 bead-assisted mass spectrometry (BAMS) laboratory assay, which has been developed with US-based Adeptrix.

Megna Health has secured EUA from the FDA for its Rapid COVID-19 IgG and IgM Combo Test Kit. Claimed to be a lateral flow based immune assay, this kit tests both IgM and IgG antibodies against coronavirus with a drop of blood sample, of less than 5uL. It provides result in less than 15 minutes. Besides studies in 411 patients, the test kit has been validated by NIH/NCI independently.

Related Companies

Content from our partners
The added value of Qarad’s multilingual freephone service to their eIFU solution
Small and simple: how medical device manufacturers select materials
Precision wire: The future of bespoke medical treatment
Topics in this article:
NEWSLETTER Sign up Tick the boxes of the newsletters you would like to receive. The top stories of the day delivered to you every weekday. A weekly roundup of the latest news and analysis, sent every Friday. The medical device industry's most comprehensive news and information delivered every month.
I consent to GlobalData UK Limited collecting my details provided via this form in accordance with the Privacy Policy
SUBSCRIBED

THANK YOU