Therapy Areas: Respiratory
Qiagen Expands QIAstat-Dx Syndromic Testing Menu
11 January 2022 - - German sample and assay technologies provider Qiagen N.V. (NYSE: QGEN) (Frankfurt Prime Standard: QIA) has launched enhancements in the commercialization of its QIAstat-Dx syndromic testing solution which enables laboratories and hospitals worldwide to test patients for multiple pathogens from one sample with new tests and the launch of a higher-throughput version that includes a new level of walk-away efficiency through the new QIAstat-Dx Smart Drawer, the company said.

The test enhancements for QIAstat-Dx, a fully integrated molecular diagnostic testing solution with one-step sample processing that provides results in about one hour, involve:

The submission of a Gastrointestinal panel for US regulatory approval designed to detect 22 common viral, bacterial and parasitic pathogens that can cause potentially life-threatening infections.

Qiagen launched a first version of this multiplex test in Europe in 2019 and is planning to submit an updated version for IVDR review and approval in 2022.

The CE-registration of a Meningitis / Encephalitis panel in Europe designed to detect 15 different pathogens and help to distinguish between meningitis (inflammation of the membrane surrounding the brain and spinal cord) and encephalitis (inflammation within the brain).

The test analyzes 15 pathogens simultaneously and enables clinicians to undertake a one-step, fully integrated molecular diagnosis of either condition in about one hour.

The new panels build on the successful uptake of two different respiratory tests designed for use on QIAstat-Dx, which is available worldwide.

The QIAstat-Dx Respiratory+ test can detect 22 different respiratory pathogens, including the SARS-CoV-2 virus (including Delta and Omicron variants of interest), while the QIAstat-Dx Respiratory 4 Plex Flu A-B/RSV/SARS-CoV-2 test is a so-called four-plex test designed for detection of the coronavirus as well as influenzas A or B, and respiratory syncytial virus.

Building on the currently available QIAstat-Dx Analyzer with one to four analytical modules, and both systems using the same test cartridges, QIAstat-Dx Rise is planned to be made available with the European CE marking to customers in the middle of 2022.

The submission for US regulatory approval is planned for the end of 2022, the company said.

QIAstat-Dx Rise has random access capacity to hold up to 18 different tests for processing, and leading to up to 56 tests in an eight-hour shift and 160 tests per day with eight analytical modules.

This new version will enable customers to raise testing efficiency and their "walk-away" time with the new QIAstat-Dx Smart Drawer.

This feature automatically detects sample types for the QIAstat-Dx panels, provides digital cartridges traceability and prioritization, and enables immediate urgent testing. With a footprint less than 60 cm, the system also requires minimal lab space and can be placed as a stand-alone device on any lab bench.


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