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.
The high-throughput system is now approved with the firm's Blood Culture ID, Gastrointestinal, Meningitis/Encephalitis, and the previously approved Respiratory Panel.
The Belgian MDx firm's sights are set on assays for cancer, infectious disease, and sepsis, as well as new iterations of its flagship Idylla platform.
By Ben Butkus