Gnome Diagnostics (GnomeDX) has applied with the US Food and Drug Administration (FDA) for an Emergency Use Authorization (EUA) for its extraction-free GnomeDX RT-PCR Covid-19 Test.

The company has selected Fluidigm, a provider of biotechnology tools, to use its Fluidigm microfluidics technology and reagents for the diagnostic test.

According to the pharmacogenomics testing company, its rapid turnaround real-time RT-PCR Covid-19 test can be performed using oropharyngeal, nasopharyngeal and nasal swab.

The test has been designed to address growing testing needs for patients, health care workers and other critical populations.

GnomeDx lab operations vice president Vicky Amann said: “Supporting our first responders and their patients are among key goals of our test development program. 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.”

GnomeDX RT-PCR Covid-19 Test runs on the Fluidigm Biomark HD system

GnomeDX is a lab certified under the US Clinical Laboratory Improvement Amendments (CLIA) and is eligible to create its own diagnostic tests for Covid-19, under FDA guidance.

The company has validated a workflow using assays developed by the Centers for Disease Control and Prevention (CDC), and designed the test to run on the Fluidigm Biomark HD system. Samples for the test can be collected using oropharyngeal and nasal swabs, avoiding invasive collection methods.

GnomeDX said that the Covid-19 testing on the Biomark HD platform would provide throughput and cost advantages that reduce the impact of capacity‑constrained supply chains.

In addition, Fluidigm’s microfluidics technology facilitates processing of more samples per batch and leverages a fraction of expensive testing reagents per sample than traditional, microwell plate-based PCR technology.

Fluidigm president and CEO Chris Linthwaite said: “We believe a significant increase in testing capacity remains critical to an effective global response to the Covid-19 crisis. 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.”