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GenMark gets CE mark for ePlex blood culture identification fungal pathogen panel

Published 21 April 2017

GenMark Diagnostics has secured CE Mark under the European In‐Vitro Diagnostic Devices Directive (98/79/EC) for its ePlex blood culture identification fungal pathogen (BCID-FP) panel.

BCID-FP is the first panel in the GenMark Sepsis Solution, which will also include BCID Gram-Positive and Gram-Negative panels.

“We are very pleased to bring the first of our three blood culture identification panels to the European market. Rapid diagnosis of blood stream infections can have significant impact on improving patient outcomes and reducing cost of therapy.

GenMark’s approach will enable this by providing the broadest pathogen inclusivity and drug resistance markers of any multiplex molecular solution on the market today,” said Hany Massarany, President and Chief Executive Officer of GenMark.

“Fungal blood stream 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.

“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,” stated Dr. Danièle Maubon, MD, PhD, of Grenoble Alpes University Hospital.

Information on the GenMark Sepsis Solution will be highlighted at the 27th European Congress of Clinical Microbiology and Infectious Diseases Meeting (ECCMID) in Vienna, Austria, from April 22-25, 2017, during conference poster sessions and a private customer symposium.

The company also reported preliminary first quarter 2017 revenue of $12.5 million, an increase of 13% over the prior year period. In addition, the company announced that during the quarter, it added more than 15 customer agreements.

“First quarter revenue was in line with our expectations and we continue to be very pleased with the increasing customer interest in our ePlex sample-to-answer system, particularly following our submissions to FDA last quarter. We finished the first quarter with over 70 agreements totaling more than 100 ePlex analyzers, many of which have already been installed in end-user sites,” added Massarany.

GenMark Diagnostics is a leading provider of multiplex molecular diagnostic solutions designed to enhance patient care, improve key quality metrics, and reduce the total cost-of-care.

Utilizing GenMark’s proprietary eSensor® detection technology, GenMark’s eSensor XT-8® and ePlex® systems are designed to support a broad range of molecular diagnostic tests with a compact, easy-to-use workstation and self-contained, disposable test cartridges.

GenMark’s ePlex®: The True Sample-to-Answer Solution™ is designed to optimize laboratory efficiency and address a broad range of infectious disease testing needs, including respiratory, bloodstream, and gastrointestinal infections.

Source: Company Press Release