NEW YORK (GenomeWeb) – GenMark Diagnostics said Thursday that it has achieved CE marking under the European In‐Vitro Diagnostic Devices Directive for its ePlex Blood Culture Identification fungal pathogen panel.
The panel is the first in the GenMark Sepsis Solution, which will also include BCID Gram-Positive and Gram-Negative panels, the firm said.
"Rapid diagnosis of bloodstream infections can have significant impact on improving patient outcomes and reducing cost of therapy," Hany Massarany, president and CEO of GenMark, said in a statement, adding GenMark's approach will enable this impact by providing "the broadest pathogen inclusivity and drug resistance markers of any multiplex molecular solution on the market today."
Danièle Maubon, a clinician at the Grenoble Alpes University Hospital, said that "fungal bloodstream infections are some of the most critical conditions we face in the clinical laboratory, and diagnosing them quickly and accurately has a significant positive impact on patient outcomes."
Maubon noted that the ePlex Fungal Pathogen Panel brings rapid and essential information regarding fungemia, and its ease of use "allows a perfect integration in the routine workflow."
GenMark also reported preliminary first quarter 2017 revenues of $12.5 million, an increase of 13 percent over the prior-year period. The firm said that it added more than 15 customer agreements during Q1, and that it finished the first quarter with more than 70 agreements for more than 100 ePlex analyzers, many of which have been installed at end-user sites.
Massarany said that first quarter revenue was in line with its expectations.