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respiratory infection

The company also said that it expects a clearance decision from US regulators in the near term on a lower respiratory tract infection test that runs on its Unyvero system.

The test detects 20 common viruses and bacteria that cause upper respiratory infections using the firm's high-throughput, automated MDx-3000 instrument.

The combined firm will be based in Gaithersburg, Maryland and will focus on infectious disease diagnostics and antimicrobial resistance prediction services. 

The test is designed to detect clinically relevant pathogens and markers of antibiotic resistance from bronchoalveolar lavage specimens.

Stakeholders discussed last year's decision by Palmetto to deny coverage for large respiratory panels and discussed the way forward for test developers and labs.

McKesson will be the exclusive distributor of the QiaStat-Dx system in US hospitals with fewer than 200 beds and non-exclusive distributor for future expansion into retail pharmacy clinics.

The QiaStat-Dx system will now be commercially available in the US along with a panel that detects more than 20 respiratory viral and bacterial pathogens.

The firm has three clinical trials in progress to validate the clinical utility of products it soon intends to submit for regulatory clearances to the FDA.

The Polish company recently received 9 million Polish złoty ($2.4 million) from the country's National Center for Research and Development to support its activities.

The company will rely more on distribution partners in Europe for its Unyvero product line while continuing highly targeted commercialization efforts in the US.

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