18th March 2020 Editorial by: Paul Carton
US Health Service Grants Qiagen Funding to Speed up COVID-19 Test-Cartridge FDA-Approval
Qiagen has received more than half a million in funding from the US Department of Health to aid the FDA approval process of its QIAstat-Dx Respiratory SARS-CoV-2 Panel test kit. The molecular-based syndromic test, which is a first of its kind to test for COVID-19, can differentiate SARS-CoV-2 from 21 other respiratory pathogens in one hour, from sample to result.
The COVID-19 testing panel will work on Qiagen's QIAstat-Dx system, an all-in-one analyzer for respiratory infections, which was introduced in Europe in 2018 and the US, in 2019. A technician simply loads a clinical sample (such as a swab) into a single-use cartridge and places it in the QIAstat-Dx analyzer and receives a result in approximately one hour. The QIAstat-DX Respiratory Panel SARS-CoV-2 test kit has undergone evaluation in four hospitals in China and at the Bichat-Claude Bernard Hospital in Paris after it passed the initial evaluation there.
The assay, which can differentiate SARS-CoV-2 from 21 other respiratory pathogens, targets the ORF1b gene (RNA-dependent polymerase) and the E-gene (envelope protein).
The regulatory status of the QIAstat-Dx Respiratory SARS-CoV-2 Panel will vary by location. The panel will be available with CE-IVD marking in Europe and US FDA EUA approval in the coming weeks, with Korean KCDC/MFDS and China's National Medical Products Administration, also been approached.
"The coronavirus emergency goes to the heart of QIAGEN's mission and expertise. Our team is partnering with customers and public health authorities worldwide to quickly scale up capacity for coronavirus testing, and also to make available the Sample to Insight QIAstat-Dx respiratory panel with SARS-CoV-2 detection," said Thierry Bernard, Interim CEO of QIAGEN and Senior Vice President, Head of the Molecular Diagnostics Business Area.
He continued,"We have scaled up production to respond to the rapid spread of COVID-19, moving to 24-hour, seven-day-a-week operations at two key sites, investing to expand capacity by 70% and adding staff. Our top priority is producing the QIAamp and EZ1 sample technologies recommended in the U.S. Centers for Disease Control guidelines for testing, as well as the new QIAstat-Dx cartridges. We are working closely with laboratories, hospitals and other customers around the world to assess their flexibility, timing and quantity needs."
Date Published: 18th March 2020
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