GenMarkDx - Improving patient care with multiplex molecular diagnostics
Scott Mendel
President and CEO
Healthcare providers need rapid diagnostic tests, now more than ever, to accurately differentiate the cause of illness. It is pertinent to mention that many illnesses have overlapping symptoms that are difficult to diagnose by symptoms alone, so identifying the specific cause helps clinicians pinpoint the most appropriate treatment. This is especially important for high-risk and hospitalized patients. Early, appropriate treatment is important to ensure that patients get the care they need for better outcomes, aids in infection control and antibiotic stewardship, and improves hospital costs.
In 1993, Jon Faiz Kayyem, Ph.D., and his team at the California Institute of Technology (CalTech) developed a novel technology based on electrochemical detection of nucleic acids on a cassette-based detection platform. Dr. Kayyem created Clinical Micro Sensors to translate this “eSensor®” technology to disposable chips. Following several technology acquisitions, in 2010, the company known as Osmetech was named GenMark Diagnostics and listed on NASDAQ. At that time, the company adapted the eSensor technology to the ePlex® Sample-to-Answer platform, integrating sample preparation, nucleic acid amplification, and eSensor detection into an easy-to-use platform that made molecular diagnostics accessible to a wide range of moderately complex hospital labs.
The ePlex System was FDA cleared in 2017, along with the original ePlex Respiratory Pathogen Panel. In 2019 GenMark launched its ePlex Blood Culture Identification Panels (BCID) to identify the broadest range of organisms that cause sepsis and bloodstream infections and their resistance genes. Most recently, with the COVID-19 pandemic, GenMark quickly responded by developing a standalone SARS-CoV-2 test that was later incorporated into the ePlex RP2 Panel (Emergency Use Authorization). GenMark continues to innovate to further build on the syndromic molecular diagnostic test menu.
Patient care is a top priority to the GenMark team, and they keep that at the top of their mind as they develop new panels, instruments, and software. “We regularly look to our customers and advisory team for input on syndromic panel development and feedback on how we can improve to ensure we are best meeting the needs of our clients and patients,” says Scott Mendel, President & CEO of GenMark.“We take a similar approach towards continuous improvement of our assays and processes and software development. An example of this is our patented Templated Comments software feature.” GenMark got feedback from their customers that transitioning from standard microbiology workflows for blood culture identification to multiplex molecular identification with resistance genes could be difficult for clinicians to interpret with just a standard results report. “We took that feedback and developed the Templated Comments module which aids in translating the ePlex results report into clinical action by allowing customers to customize comments using specific ePlex results and their own local antibiogram data and pharmacy formulary,” adds Scott.
“Designed for the Patient, Optimized for the Lab describes how we approach infectious disease diagnostics with the ePlex system and panels. There are a few key factors that help GenMark to differentiate ourselves from our competition,” explains Scott. “First, we have taken a customer-centric approach to product development, building usability and workflow benefits into our cartridges and instrumentation.” On the diagnostic test side, they do extensive customer research to ensure they develop the most clinically relevant panels that identify organisms and resistance genes that deliver clinically actionable results. As an example, extensive customer input drove the ePlex BCID Panel design. “Our customers told us that broad panel inclusivity, including many contaminant organisms, anaerobes, and multidrug resistant organisms, along with their resistance genes, was crucial in a BCID Panel,” adds the steadfast leader. “We used that information to guide our product development and often get feedback from customers that our BCID panels are best in class because of their inclusivity. Second, we take great pride in the service and support we deliver, consistently ranking top among our peers in customer satisfaction surveys.”
Implementing rapid, syndromic diagnostic tests, like the ePlex RP2 and BCID panels, enables clinicians to get fast, comprehensive information hours or days sooner than conventional diagnostic methods. This enables them to make treatment decisions that can lead to better hospital bed management, including reducing ED wait times. More importantly, it can also result in better patient care and a reduction in unnecessary antibiotics, which leads to improved antimicrobial stewardship and overall hospital cost savings.
For instance, a customer had a case of a patient with a Pseudomonas aeruginosa detected in a positive blood culture with the ePlex BCID Gram-Negative Panel. The organism carried a metallo-beta-lactamase gene (VIM). Having the identification only 2 hours after the blood culture turned positive when it normally would take 72 hours to identify the organism was significant. This organism is uncommon in blood cultures, and the patient was in the ICU and not on appropriate therapy since it did not include coverage against metallo-beta-lactamases. They were able to adjust therapy within only 3 hours of positive blood culture, making a significant difference in patient care and potentially saving the patient’s life.
GenMark has learned a lot over the past couple of years and has upgraded its support team to meet client’s needs in this area. They now have a staff of Infectious Disease Specialists, including licensed Infectious Disease Pharmacists and Microbiologists, and LIS integration specialists deployed to help customers at every step of the BCID implementation to ensure a streamlined and coordinated process. “The next panels in our development pipeline are a Gastrointestinal Infection Panel (GI) for detection of the most common bacteria, viruses and parasites that cause diarrheal disease and the next step in our respiratory pathogen panel franchise with the development and launch of RP3, which will build on the success of our RP2 Panel with additional targets and workflow improvements. GenMark is committed to improving the lives of patients and their families by delivering innovative, diagnostic solutions to our customers”, adds Scott.
“We regularly look to our customers and advisory team for input on syndromic panel development and feedback on how we can improve to ensure we are best meeting the needs of our clients and patients.”
