The Rapid Turnaround Real-Time RT-PCR™ COVID-19 Test, which can be performed via oropharyngeal, nasopharyngeal and nasal swab, is intended to meet growing testing needs for patients, health care workers and other critical populations across central Ohio. GnomeDX has filed for Emergency Use Authorization (EUA) for its extraction-free GnomeDX RT-PCR COVID-19 Test from the U.S. Food and Drug Administration (FDA).
“Supporting our first responders and their patients are among key goals of our test development program,” said Vicky Amann, Vice President for Lab Operations at GnomeDx. “Our CLIA certified genomics lab is ideally suited to this challenge, and we are committed to support our community in any way we can to respond to the pandemic.”
“GnomeDX selected the Fluidigm integrated fluidic circuit technology, reagents and workflow because they provide high-performance sample throughput that is unmatched by microwell plate-based PCR assays for the SARS-CoV-2 virus,” Amann added.
GnomeDX is a high-complexity lab certified under the Clinical Laboratory Improvement Amendments (CLIA) in the United States and eligible under FDA guidance to create its own diagnostic tests for COVID-19. GnomeDX has validated a workflow using assays developed by the Centers for Disease Control and Prevention designed to be run on the Fluidigm Biomark™ HD system.
Because sample collection methods for the test include oropharyngeal and nasal swabs, it does not require invasive nasopharyngeal collection.
COVID-19 testing on the Biomark HD platform provides throughput and cost advantages that reduce the impact of capacity‑constrained supply chains. Fluidigm’s microfluidics technology enables processing of more samples per batch and uses a fraction of expensive testing reagents per sample as compared to more traditional, microwell plate-based PCR technology.
“We believe a significant increase in testing capacity remains critical to an effective global response to the COVID-19 crisis,” said Chris Linthwaite, President and CEO of Fluidigm. “As governments, medical institutions and private labs look for solutions, speed, scale and automation are paramount. Since the beginning of the pandemic, we have been supporting labs around the world as they build out testing infrastructure that meets these important criteria.
“The Biomark HD platform can generate as many as 6,000 test results per day on a single instrument. More and more labs are adopting the Fluidigm model of COVID-19 testing, which offers much-needed high-throughput capability per system. We also support multiple approaches to sample collection, having recently filed for Emergency Use Authorization from the FDA for an extraction-free saliva-based test to detect COVID-19.
“We are honored to have been chosen by GnomeDX to provide a platform for its COVID-19 test to provide critically needed testing capacity in central Ohio.”
In early June, Fluidigm filed for Emergency Use Authorization with the FDA for an extraction-free saliva-based test to detect the SARS‑CoV‑2 virus. The test was developed in collaboration with scientists at the McDonnell Genome Institute and the Department of Genetics at the Washington University School of Medicine in St. Louis.
With respect to the Fluidigm test, Fluidigm has filed for Emergency Use Authorization with the FDA. The test has been validated by Fluidigm, but the FDA’s independent review of this validation is pending. The FDA may require additional data, validation and/or testing, and may not ultimately provide authorization for EUA requests. An EUA, if granted, does not constitute FDA clearance or approval, but would allow use by authorized laboratories only while the EUA is in effect.