The firm will encounter stiff competition, particularly from BioMérieux and Luminex, but there are untapped opportunities for adoption, according to industry analysts.
The firm expects that revenues from ePlex installations at US customer sites will positively impact its financial results for the second half of 2017.
The test, which runs directly from a patient nasopharyngeal swab, is the fifth assay on the firm's sample-to-result molecular diagnostics platform.
CEO Hany Massarany said that 2017 will be a pivotal year for the company as it expects to launch the ePlex sample-to-answer system in the US.
The FDA cleared the test to enable clinicians to provide better antibiotic treatment to patients with lower respiratory tract infections or sepsis.
CLIA waivers are driving the promise of MDx uptake in physicians’ offices, but achieving adoption in larger settings will remain a strategic imperative.
GenMark's CEO said that the firm continues to focus on growing the ePlex instrument's global reach and expanding its menu.
Encouraged by positive customer feedback from early installations, the firm is shifting its sales focus to the ePlex system and respiratory pathogen panel.
The test detects 11 viruses and three bacterial pathogens in approximately one hour and requires two minutes of hands-on time.
The new platform, called Fusion, is an addition to the Panther system and will run qPCR assays with three "mini panels" currently in the works.