GenMark Achieves CE Mark for its ePlex® Blood Culture Identification Gram-Positive and Gram-Negative Panels
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.website at www.genmarkdx.com under the investor relations section and will be archived for future reference. To listen to the conference call, please dial (877) 312-5847 (US/Canada) or (253) 237-1154 (International) and use the conference ID number 48903152 approximately five minutes prior to the start time.
ABOUT GENMARK DIAGNOSTICS
GenMark Diagnostics (NASDAQ: GNMK) 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. For more information, visit www.genmarkdx.com.
SAFE HARBOR STATEMENT
This press release includes forward-looking statements regarding events, trends and business prospects, which may affect our future operating results and financial position. Such statements, including, but not limited to, those regarding our future financial performance and the clinical, economic and quality impacts of new products, are all subject to risks and uncertainties that could cause our actual results and financial position to differ materially. Some of these risks and uncertainties include, but are not limited to, our ability to successfully commercialize our ePlex system and its related test menu in a timely manner, constraints or inefficiencies caused by unanticipated acceleration and deceleration of customer demand, our ability to successfully expand sales of our product offerings outside the United States, and third-party payor reimbursement to our customers, as well as other risks and uncertainties described under the “Risk Factors” in our public filings with the Securities and Exchange Commission. We assume no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made.
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GenMark Diagnostics, Inc.
President/Chief Executive Officer
Source: GenMark Diagnostics, Inc.
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