Sunday, March 7

GenMark ePlex® RP2 Panel Predicted to Detect Known SARS-CoV-2 Variants Currently in Circulation Based on in silico Analysis

CARLSBAD, Calif., Feb. 22, 2021 (GLOBE NEWSWIRE) — GenMark Diagnostics, Inc. (NASDAQ: GNMK), a leading provider of automated, multiplex molecular diagnostic testing systems, today announced that its ePlex Respiratory Pathogen Panel 2 (RP2) is predicted to detect known SARS-CoV-2 variants currently in circulation.

As the COVID-19 pandemic continues to evolve, GenMark is routinely monitoring publicly available databases for new SARS-CoV-2 strains and variants and conducting bioinformatic analyses to determine if the mutations present in the viral genome would impact detection of these variants on the ePlex RP2 Panel. The recently identified SARS-CoV-2 variant strains include multiple mutations with the majority occurring in the spike protein, or S gene region and additional mutations found in the nucleoprotein region, or N gene. The ePlex RP2 Panel targets two unique regions of the N gene; the currently identified N gene mutations for the variants listed above are found outside of the sequence region targeted by the SARS-CoV-2 assays on the ePlex RP2 Panel and therefore the following variant strains currently in circulation are predicted to be detected based on the in silico analysis: B.1.1.7 (UK), B.1.351 (South Africa) , P.1 (Brazil), COH.20G/677H and COH.20G/501Y (Ohio, USA) and B.1.429 (California, USA). GenMark will continue to update the list of variants detected by the ePlex RP2 Panel. For the most up-to date information on the SARS-CoV-2 variants detected, please visit: https://gnmk.info/SARSCoV2-Variants

The U.S. ranks 43rd in the world in sequencing of positive SARS-CoV-2 viral samples. To address this challenge, the Tracking COVID Variants Act was recently introduced with a goal to significantly boost funding and support for advanced molecular detection technologies at the Centers for Disease Control and Prevention (CDC) to provide robust genetic surveillance and sequencing activities for SARS-CoV-2 variants. GenMark joined with other members of the American Society for Microbiolgy Corporate Council in supporting this important effort to boost our nation’s genomic surveillance and sequencing capacity by signing a stakeholder letter, expressing support for the bill. Specifically, the proposed bill authorizes up to $1.75 billion in emergency supplemental funding for the CDC. For more information on this important initiative: https://asm.org/Articles/Policy/2021/Feb-21/ASM-Hails-Congressional-Proposal-of-1-75-Billion-f

About the ePlex RP2 Panel

The ePlex RP2 Panel provides results for more than 20 viruses and bacteria that cause common and often serious respiratory infections, including COVID-19, flu, bronchitis, pneumonia and the common cold. With less than one minute of laboratory hands-on time and a total run time of less than two hours, the ePlex RP2 Panel is easy to use, rapid, and can be run in a broad array of hospital and reference lab settings.

The ePlex RP2 Panel helps address the double burden of this respiratory illness season by quickly identifying or ruling out the responsible pathogen(s) to enable proper treatment, potentially minimizing unnecessary use of antibiotics, which can save lives and reduce antibiotic resistance. Syndromic panels, like the ePlex RP2 Panel, allow clinicians to get the answers they need across a broad set of pathogens, enabling appropriate triage and treatment of hospitalized and critically ill patients from a single swab.

The EUA-authorized and CE-Marked ePlex RP2 Panel runs on GenMark’s ePlex instrument, which is FDA cleared and CE-Marked for use with the company’s ePlex RP Panel and Blood Culture Identification (BCID) Panels (Gram-positive, Gram-negative and Fungal pathogens).

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, our ability to detect all current and future circulating SARS-CoV-2 variant strains, the continued progression of the associated public health emergency, 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.

Investor Relations Contact
Leigh Salvo
(415) 937-5404
ir@genmarkdx.com