GenMark Diagnostics’ ePlex Respiratory Pathogen Panel 2 (RP2) Receives EUA from FDA - Seite 2

A small rural hospital west of Dallas, Graham Regional Medical Center, began using RP2 as the COVID-19 surge hit in mid-July. “RP2 provides our hospital with incredible peace of mind and value in helping us serve our patients, which includes a large geriatric patient population that is at increased risk for COVID-19. Since implementing RP2, we went from a seven-to-10-day turnaround time, to getting results in under two hours,” said Teri Robertson, BSMT, laboratory director at the hospital in Graham, Texas. “The multiplex test not only benefits patients, but it helps with resource management, in particular, for our staff. One of our nurses recently spiked a fever and we tested her using RP2 and sent her home. Within two hours, the test result indicated she was negative for COVID-19 but positive for rhinovirus (the common cold), so she was able to come back to work as soon as she recovered. A negative result for COVID-19 alone would not have given us the confidence to bring her back to work without knowing the cause of her fever. This is critical to helping us ensure we have staff available to treat patients during the pandemic.”

The RP2 Panel includes a new, simplified workflow making it even easier for labs to run the test. Incorporating COVID-19 into the existing ePlex Respiratory Pathogen (RP) Panel streamlines the diagnostic process for hospitals by allowing them to check for multiple pathogens with a single test, saving time and resources and improving bed management. A study at two acute large tertiary care hospitals demonstrated that using the ePlex RP Panel in the Emergency Department led to earlier patient results, which resulted in an 8.4% reduction in hospital admissions.²

The ePlex RP2 Panel is also approved as a tool for clinical diagnosis in the European market, having announced CE Mark achievement on Sept. 8, 2020 under the European In‐Vitro Diagnostic Devices Directive (98/79/EC).

The ePlex RP2 Panel is designed for use with the company’s ePlex system, along with the ePlex RP Panel and Blood Culture Identification (BCID) Panels (gram-positive, gram-negative and fungal pathogens), all of which have been cleared by the FDA and achieved CE Mark. In March, GenMark received EUA for its ePlex SARS-CoV-2 Test. Certified by the FDA under the Clinical Laboratory Improvement Amendments (CLIA) as moderately complex, the ePlex system is easy to operate and can be used in a wide variety of hospital and reference lab settings.