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GenMark Diagnostics, Inc. (Nasdaq: GNMK), a leading provider of automated, multiplex molecular diagnostic testing systems, today announced it has achieved CE Mark under the European In-Vitro Diagnostic Devices Directive (98/79/EC) for its ePlex Blood Culture Identification Gram-Positive (BCID-GP) Panel and its Blood Culture Identification Gram-Negative (BCID-GN) Panel. BCID-GP and BCID-GN complete the ePlex family of sepsis panels, which also includes the BCID Fungal Pathogen (BCID-FP) Panel that achieved CE Mark in April 2017.
“We are very pleased to bring these additional Blood Culture Identification (BCID) panels to the European market. This rounds out our family of ePlex blood stream infection assays, which we’ve designed to offer 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. “Based on multiple internal and external studies, we are very pleased with the performance of all three ePlex BCID panels, which we believe will have a significant impact on the management of a critical disease state, while bringing clinical, economic, and quality benefits to ePlex customers and their patients,” added Massarany.
“Sepsis resulting from blood stream infection has a high mortality rate and is one of the most expensive conditions managed in the hospital. Rapid, accurate, and easy-to-use diagnostics are needed to ensure timely pathogen identification and to inform appropriate therapy selection,” stated Prof. Brigitte König, Institute of Medical Microbiology and Infectious Diseases, Leipzig University. “The ePlex BCID solution, with Gram-Positive, Gram-Negative, and Fungal Pathogen Panels, provides the broadest pathogen and resistance gene coverage of available rapid molecular tests while also being simple enough to perform 24/7, ensuring physicians receive lab results as quickly as possible and helping to improve outcomes for critical sepsis patients.”
The Company plans to release its second quarter earnings results on Tuesday, August 1, 2017. Management will hold a conference call to review the Company’s financial performance starting at 8:30 a.m. ET on the same day. The conference call will be concurrently webcast. The link to the webcast will be available on the GenMark Diagnostics, Inc….