Qiagen Snags FDA Nod For Molecular Diagnostic System, Announces US Launch

Qiagen NV QGEN shares were spiking higher Monday following the announcement of FDA approval for its molecular diagnostic testing system.

What Happened

Germany-based Qiagen, a provider of sample and assay technologies for molecular diagnostics and applied testing, said the FDA has given 510(k) clearance for its QIAstat-Dx syndromic testing system.

Following the clearance, the company announced the U.S. launch of the testing system along with the multiplex QIAstat-Dx Respiratory Panel for simultaneous qualitative detection and identification of multiple respiratory viral and bacterial pathogens.

QIAstat-Dx is a fast, cost-effective and flexible next-gen multiplex molecular diagnostic system, Qiagen said.

"The system, based on the proprietary DiagCORE technology, received CE-IVD marking in January 2018 and already has a significant installed base." 

Why It's Important

Demand for syndromic testing with molecular diagnostics is growing rapidly, as about 35 million cases of influenza each year lead to several hundred thousand hospitalizations and as many as 56,000 deaths in the U.S., the company said, citing CDC estimates. 

Qiagen estimates the total addressable market for respiratory syndromes and flu testing to be about 1.5 million tests annually in the U.S.

What's Next

The QIAstat-Dx comes with a comprehensive respiratory panel that detects more than 20 pathogens. Qiagen said it plans to launch a gastrointestinal panel later in 2019.

"With the ability to multiplex as high as 48 targets, a deep pipeline is planned that will span infectious diseases, oncology, companion diagnostics and other disease areas," the company said. 

Qiagen shares were trading up by 3.61 percent at $38.42 at the time of publication Monday. 

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Photo courtesy of Qiagen.