Study Highlights Potential Clinical Value of ePlex® Blood Culture ID Panels

Major teaching hospital in Grenoble, France demonstrates that ePlex BCID results could have modified antimicrobial treatment in 45% of patients

CARLSBAD, Calif., Feb. 16, 2021 (GLOBE NEWSWIRE) -- GenMark Diagnostics, Inc. (NASDAQ:GNMK), a leading provider of automated, multiplex molecular diagnostic testing systems, announced today the publication of a manuscript in Frontiers in Cellular and Infection Microbiology that highlights strong performance and the potential clinical impact of the ePlex Blood Culture Identification (BCID) Panels. The study, "Evaluation of Microbiological Performance and the Potential Clinical Impact of the ePlex^® Blood Culture Identification Panels for the Rapid Diagnosis of Bacteremia and Fungemia,” looked prospectively at the identification of pathogens and antimicrobial resistance genes, as well as retrospectively analyzing clinical outcomes, based on ePlex BCID Panel results compared to standard of care.

Key Study Findings

In an analysis of 158 bloodstream infection episodes, the ePlex Blood Culture Identification Panels were utilized to assess potential therapeutic interventions in a timelier manner compared to conventional microbiology. With an overall sensitivity of 98%, the rapid result from the ePlex BCID Panels would have allowed the clinical team to modify treatment in 45% of patients. Moreover, lack of an ePlex BCID result was considered a loss or a probable loss of opportunity for modification of therapy in 28% of patients.

"Acceleration of the diagnosis of bacteremia using new rapid assays should become the new Gold standard to improve the management and the prognosis of septic patients,” said Yvan Caspar, PhD, PharmD, Hospital-University Practitioner, Bacteriology Laboratory, National Reference Center for Francisella, Grenoble Alpes University Hospital. (Full citation: Bryant, S. et. al. (2020) Frontiers in Cellular and Infection Microbiology. Doi: 10.3389/fcimb.2020.594951). Dr. Caspar will be presenting these and other findings in a webinar hosted by XTalks and sponsored by GenMark on February 23, 2021. For more information or to register for the webinar visit: https://xtalks.com/webinars/rapid-blood-culture-identification-a-retrospective-clinical-analysis/

About ePlex BCID Panels

The trio of ePlex BCID Panels (Gram-Negative, Gram-Positive and Fungal Pathogen) can save days over conventional methods in the identification of pathogens that cause bloodstream infections (BSI) and sepsis. The ePlex BCID Panels are the broadest FDA-cleared panels on the market with 60 organism targets and 10 resistance genes, allowing clinicians to rapidly identify the causative agent(s) of BSI and sepsis for more patients. The panels also include identification of more organisms that are often considered contaminants, potentially leading to faster de-escalation of unnecessary antimicrobial treatment. Since unnecessary overuse of antibiotics is the primary driver of antibiotic resistance today, rapid de-escalation of therapy can help reduce the proliferation of further resistance while also saving patients from unnecessary adverse effects.

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 compact, easy-to-use workstations 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.

Forward-Looking Statements
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 are 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, the particular clinical value of our BCID Panels in respect of a particular institution or patient population, the impact of our BCID Panels on antimicrobial stewardship outcomes, our ability to satisfy the supply demands of our customers, and 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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