Zacks Investment Research | Feb 26, 2020 09:05PM ET
QIAGEN N.V. (NYSE:QGEN) announced the shipping of its latest QIAstat-Dx Respiratory Panel 2019-nCoV test kit to four hospitals in China for evaluation purposes. The latest test kit helps detect the novel coronavirus SARS-CoV-2, thus adding rapid Sample to Insight syndromic testing to the company’s molecular testing solutions portfolio during the public health emergency.
Currently, QIAGEN is on track to ship QIAstat-Dx testing kits to public health institutions in other regions, including Europe, South-East Asia and the Middle East. Notably, the QIAstat-Dx system was introduced in Europe in 2018, after receiving the CE mark. The system was also cleared by the FDA in mid-2019.
With the recent developments in the QIAstat-Dx system, QIAGEN aims to strengthen its foothold in the Molecular Diagnostics business globally.
A Peek Into the Product
The QIAstat-Dx Respiratory 2019-nCoV Panel is the latest version of the existing QIAstat-Dx respiratory panel for differential analysis of 21 viral and bacterial pathogens in respiratory syndromes. It enables better syndromic testing, with Sample to Insight workflows.
The expanded panel is currently being assessed at a Paris-based hospital, where the latest panel, with SARS-CoV-2, is being evaluated against the real-time polymerase chain reaction (RT-PCR) testing.
Significance of the Panel
Since January, QIAGEN has been providing necessary instruments and consumables to help detect the virus in China and other regions. Per the company, it proactively made sure to make the newly developed QIAstat-Dx respiratory panel with SARS-CoV-2 available for detection purposes.
However, the regulatory status of the QIAstat-Dx respiratory panel will vary by location, given the growing response to the coronavirus outbreak. An emergency authorization from the United States, the Korean KCDC/MFDS, the FDA and China’s National Medical Products Administration (“NMPA”) to market the latest panel is currently in the company’s pipeline. Meanwhile, the panel will be available in Europe and other regions, with CE-IVD marking.
Industry Prospects
Per a report by Zacks Investment Research
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