June 12 2020 - 08:00PM
GlobeNewswire Inc. Fluidigm Files for FDA Emergency Use Authorization for Saliva-Based Advanta Dx SARS-CoV-2 RT-PCR Test for COVID-19
Fluidigm Corporation (Nasdaq:FLDM), an innovative biotechnology tools provider with a vision to improve life through comprehensive health insight, today announced it has filed for Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for an extraction-free saliva-based test to detect the SARS-CoV-2 virus. The test, developed in collaboration with scientists at the McDonnell Genome Institute and the Department of Genetics at Washington University School of Medicine in St. Louis, provides an easy-to-administer protocol that does not require collection via invasive nasopharyngeal swab and is processed on the Biomark™ HD microfluidics platform.
The Advanta™ Dx SARS-CoV-2 RT-PCR Assay is intended for use by high-complexity labs certified under the Clinical Laboratory Improvement Amendments in the United States. The test would enable health care providers to conduct testing through collection of saliva, which is significantly easier than invasive nasopharyngeal swab collection and could enhance testing coverage in critical populations.
“Rapid, reliable testing that is widely available to the public is essential in combatting the COVID-19 pandemic,” said Jeffrey Milbrandt, MD, PhD, Executive Director of the McDonnell Genome Institute and head of the Department of Genetics at Washington University School of Medicine. “The close collaboration between teams at Washington University and Fluidigm aided our efforts to quickly develop this high-throughput assay for SARS-CoV-2 that relies on a saliva sample. Such a test could help overcome supply chain bottlenecks that have limited testing for COVID-19 and help identify infections.”
The Advanta Dx SARS-CoV-2 RT-PCR test on the Biomark HD platform provides throughput and cost advantages that reduce the impact of capacity-constrained supply chains. The company’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.
“There’s an urgent need to simplify testing for COVID-19 so that people who are infected can be easily and quickly identified,” said Richard Head, Director of the Genome Technology Access Center at the McDonnell Genome Institute. “The test we developed in collaboration with Fluidigm doesn’t require RNA extraction, a time-consuming and expensive step necessary to other tests for SARS-CoV-2. Our test could be easily scaled up and made widely available.”
Fluidigm will provide updates with regard to timing of broad commercial availability of the Advanta Dx SARS-CoV-2 RT-PCR test.
“Our high-throughput saliva-based test enhances testing capacity and simplifies COVID-19 testing while eliminating the need for hard-to-source components such as extraction kits,” said Chris Linthwaite, President and CEO of Fluidigm. “Speed, scale and early detection have been critically important since the beginning of this health crisis, and the addition of improvements in ease of use — eliminating the invasive nasopharyngeal swab protocol without compromising performance — could make this test a game changer for the next phase of the global pandemic response.
“The Fluidigm approach bends the cost curve, increases ultrahigh-throughput testing capability per system, eliminates the expense and complexity of extraction, and provides a less invasive sample collection process that could open testing access to large numbers of people,” Linthwaite said. “We believe frequent testing of a large percentage of the population is the best path forward, and a critical foundation for getting the global economy back to work.
“We are truly honored for the opportunity to collaborate with Washington University School of Medicine to bring this much-needed innovation in COVID-19 testing.”
The Advanta Dx SARS-CoV-2 RT-PCR Assay is the subject of an EUA filing with the FDA. The FDA may require additional data, validation and/or testing, and may not ultimately provide authorization. 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. https://ih.advfn.com/stock-market/NASDAQ/fluidigm-FLDM/stock-news/82654103/fluidigm-files-for-fda-emergency-use-authorization