After receiving premarket notification (510(k)) clearance from FDA, Qiagen, Germantown, Md, and Hilden, Germany, has announced the US launch of its QIAstat-Dx syndromic testing system. At launch, the system’s menu will include the multiplex QIAstat-Dx respiratory panel for simultaneous qualitative detection and identification of multiple respiratory viral and bacterial pathogens.
QIAstat-Dx is a multiplex molecular diagnostic system that enables fast, cost-effective and flexible syndromic testing, with sample-to-insight solutions powered by Qiagen chemistries. Based on the company’s proprietary DiagCore technology, the system received the CE mark in January 2018 and has already achieved a significant installed base.
In the United States, QIAstat-Dx is being launched with a comprehensive respiratory panel that detects more than 20 pathogens. The panel is the first of many assays planned for QIAstat-Dx in the US market, including the planned launch of a gastrointestinal panel later in 2019. With the ability to multiplex as many as 48 targets, QIAstat-Dx is eventually expected to have a broad menu that will span companion diagnostics, infectious diseases, oncology, and other disease areas.
The QIAstat-Dx respiratory panel is a multiplexed nucleic acid test that evaluates nasopharyngeal swabs obtained from individuals suspected of having respiratory tract infections. The panel identifies the following pathogens and subtypes: adenovirus, Bordetella pertussis, Chlamydophila pneumoniae, coronavirus 229E, coronavirus HKU1, coronavirus NL63, coronavirus OC43, human metapneumovirus A+B, influenza A, influenza A H1, influenza A H3, influenza A H1N1/pdm09, influenza B, Mycoplasma pneumoniae, parainfluenza virus 1, parainfluenza virus 2, parainfluenza virus 3, parainfluenza virus 4, rhinovirus/enterovirus, and respiratory syncytial virus A+B.
The demand for syndromic testing with molecular diagnostics is growing rapidly, as a way to accurately evaluate infections and other diseases that manifest as a set of symptoms with uncertain causes. For the United States, Qiagen estimates the total addressable market in respiratory syndromes and flu testing at about 1.5 million tests per year.
“QIAstat-Dx delivers the precision of molecular testing to identify hard-to-diagnose respiratory infections, which sicken millions of US patients each year and kill tens of thousands,” says Thierry Bernard, senior vice president and head of molecular diagnostics for Qiagen. “We are pleased to roll out the QIAstat-Dx respiratory panel for healthcare providers as they begin to prepare for the 2019–2020 flu season.
“DiagCore has been enthusiastically received in Europe and other regions of the world for its rapid, clear insights in clinics and other near-patient settings, as well as its cost-efficiency,” adds Bernard. “We now look forward with the launch of QIAstat-Dx to similar success in the United States. QIAstat-Dx will provide physicians with results to aid in the appropriate diagnosis and treatment for each patient. We are developing a deep menu of additional multiplex panels, such as tests for gastrointestinal syndromes and meningitis infections.”
For further information, visit Qiagen.
Featured image: Qiagen preparation research laboratory.