Product News: QIAGEN gains funding for approval process of QIAstat-Dx test kit for COVID-19

The test kit aims to differentiate novel coronavirus from 21 other pathogens implicated in respiratory syndromes

18 Mar 2020

QIAGEN has announced that it will develop a new QIAstat-Dx test kit to differentiate the novel SARS-CoV-2 coronavirus from 21 other serious respiratory infections and will receive advanced development support from the U.S. Department of Health and Human Services' Office of the Assistant Secretary for Preparedness and Response. Accelerated development of the QIAstat-Dx test kit further expands QIAGEN’s global mobilization for the emergency, which already includes a dramatic increase in production of components for a full range of U.S. and international testing protocols.

QIAGEN’s QIAstat-Dx solution to help in the response to COVID-19 disease becomes the first syndromic testing product selected for development through ASPR's Biomedical Advanced Research and Development Authority (BARDA) streamlined selection process, known as an easy broad agency announcement. BARDA will contribute $598,000 to accelerate QIAGEN's evaluation of the testing cartridge that detects the genetic material of SARS-CoV-2, the virus that causes COVID-19.

The QIAstat-Dx kit will be a molecular testing panel designed to aid in the diagnosis of patients with respiratory syndromes, in about one hour, by differentiating the novel coronavirus from 21 other bacterial and viral respiratory pathogens. QIAGEN’s panel will include assays targeting two genes used to detect the pathogen behind the disease, Severe acute respiratory syndrome-related coronavirus 2 (SARS-CoV-2). The virus was provisionally called 2019-nCoV when it first surfaced.

“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. “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.”

QIAGEN is aggressively managing supply chains and customer service to help address the pandemic. The company has worked with customers to help support laboratory-developed tests, including applications for QIAGEN automation systems. Unlike other companies, QIAGEN is not facing supply chain interruptions from China or other markets. For customers facing delays or allocations, QIAGEN is working out individualized supply plans and alternative workflow solutions.

The HHS funding and QIAGEN’s discussions with the U.S. Food and Drug Administration (FDA) are the first steps to adding the QIAstat-Dx syndromic testing solution to U.S. efforts to contain the outbreak.

In the rapidly evolving global response to the coronavirus outbreak, 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 other markets in the coming weeks.

The QIAstat-Dx system was introduced in Europe in 2018 and in the United States in mid-2019. It enables fast, cost-effective and easy-to-use syndromic testing with Sample to Insight workflows. A technician simply loads a clinical sample (such as a swab) into a single-use QIAstat-Dx cartridge and places it in the analyzer. QIAGEN chemistries for sample processing and analysis are built in, and the QIAstat-Dx instrument delivers results in about one hour.

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