QIAGEN N.V. 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.
Per a report by Grand View Research, the global molecular diagnostics market size was valued at $9.2 billion in 2019 and is expected to expand, seeing a CAGR of 9%, between 2020 and 2027. Technological advancements in molecular diagnostics are expected to be the primary driver behind the market’s growth.
Given the market potential, the shipping of test kits and further evaluations of the panel is well-timed.
Recent Developments in Molecular Diagnostics
Of late, QIAGEN has been witnessing a slew of developments in its molecular diagnostics business arm.
The company is currently providing various testing solutions for SARS-CoV-2 like enabling laboratory-developed tests (LDTs), mid- and high-throughput automation, and two new RT-PCR tests for the detection of SARS-CoV-2. However, the RT-PCR tests (developed at QIAGEN sites in China and the United States) will be available for research purposes only.
QIAGEN’s QuantiFERON-TB Gold Plus was adopted by Nigeria for the latent TB testing in February. Further, the company announced the receipt of the CE Mark for its therascreen PIK3CA (phosphatidylinositol3-kinase catalytic subunit alpha) Rotor-Gene Q (RGQ) PCR Kit and its subsequent Europe launch.
In January, QIAGEN launched the QIAGEN Clinical Insights (“QCI”) Precision Insights in Europe, with the inclusion of the European Society for Medical Oncology (“ESMO”) guidelines and European Medicines Agency (“EMA”) approved oncology drugs catalogue. Further, QIAGEN announced a collaboration with Amgen to develop a tissue-based therascreen test paired with investigational treatment AMG 510 to identify patients, whose cancer has KRAS G12C mutation.
Shares of QIAGEN have dipped 8.7% in the past year compared with the industry’s 6.5% decline.
Zacks Rank & Key Picks
Currently, the company carries a Zacks Rank #3 (Hold).
Some better-ranked stocks from the broader medical space are ResMed Inc. RMD, Medtronic plc MDT and Hill-Rom Holdings, Inc. HRC.
ResMed has a projected long-term earnings growth rate of 12%. It currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Medtronic’s long-term earnings growth rate is estimated at 7.4%. The company presently carries a Zacks Rank #2.
Hill-Rom’s long-term earnings growth rate is estimated at 11.1%. It currently carries a Zacks Rank #2.
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