A widespread healthcare infection is qualitatively detected using a molecular assay kit.
Qiagen NV (Venlo, The Netherlands), provider of sample and assay technologies, announced that its artus Clostridium difficile
QS-RGQ MDX kit has been cleared by the US Food and Drug Administration (Silver Spring, MD, USA) for the qualitative detection of Clostridium difficile.
The FDA has also granted 510(k) regulatory clearance for the QIAsymphony RGQ MDx system, Qiagen's flagship automation platform that is transforming laboratory workflows and driving dissemination of molecular diagnostics.
The US milestone for Qiagen's global rollout of its sample-to-result automation platform, together with the FDA clearance of the first in a portfolio of tests for hospital acquired infections (HAIs), supports the expected growth in QIAsymphony placements globally to more than 1,250 by year-end 2014 and 1,500 by year-end 2015, the company said.
QIAsymphony RGQ MDx is a modular system for cost-effective handling of entire laboratory workflows. The three modules are QIAsymphony SP for sample preparation, QIAsymphony AS for assay setup, and QIAGEN's real-time PCR detection platform Rotor-Gene Q MDx, which received FDA clearance in 2012.
The QIAsymphony family has the broadest test menu in its category in Europe and other markets. In the United States until now the system has been primarily used for laboratory-developed assays. The FDA clearance therefore marks an important milestone as a record number of assays are now positioned to be submitted for clearance or approval in the United States, a company representative said.
With the launch of the artus C. difficile
test, QIAGEN now offers four FDA-regulated diagnostics designed to run on the QIAsymphony family of automated platforms. In Europe, more than 20 CE-marked assays run on the system. Innovation continues to expand the content menu, with about 35 new tests in development. The artus C. difficile
kit, already available in Europe, will be the first US launch among Qiagen's advanced diagnostics for healthcare-associated infections.
Additional workflows for HAIs include the artus VanR QS-RGQ MDx Kit for detection of vancomycin-resistant bacteria, available in Europe and expected to be submitted in the second quarter 2014 to the FDA; the artus MRSA QS-RGQ MDx Kit for methicillin-resistant Staphylococcus aureus
(MRSA), expected to be launched in Europe during the second quarter 2014 and to be submitted to the FDA in the third quarter 2014; and further other additions under development. QIAGEN also is in advanced stages of developing test kits for diagnosis of group B streptococcus and Herpes Simplex Virus (HSV1/2).
The artus C. difficile
test was developed in partnership with IntelligentMDx under a multiyear agreement. IntelligentMDx (Cambridge, MA, USA) has entered into a multi-year development and license agreement with Qiagen (Venlo, The Netherlands) to design, develop, and manufacture several undisclosed CE-marked and FDA cleared diagnostic tests for use on Qiagen's QIAsymphony RGQ automated platform. Financial terms have not been disclosed.