SOUTH SAN FRANCISCO, Calif.—Fluidigm Corporation announced today that the company 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 doesn’t require collection via invasive nasopharyngeal swab. The tests are processed on the Biomark HD microfluidics platform.
“Rapid, reliable testing that is widely available to the public is essential in combatting the COVID-19 pandemic. 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,” said Jeffrey Milbrandt, M.D., Ph.D., executive director of the McDonnell Genome Institute and head of the Department of Genetics at Washington University School of Medicine. “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 Assay is intended for use by high‑complexity labs certified under the Clinical Laboratory Improvement Amendments in the U.S. The test would enable health care providers to conduct testing through collection of saliva, which could enhance testing coverage in critical populations.
The assay provides throughput and cost advantages that reduce the impact of capacity-constrained supply chains. Fluidigm’s microfluidics technology reportedly enables processing of more samples per batch, and uses a fraction of expensive testing reagents per sample as compared to more traditional, micro well 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. 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,” noted Richard Head, director of the Genome Technology Access Center at the McDonnell Genome Institute.
Fluidigm plans to provide updates on the timing of broad commercial availability of the Advanta 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,” stated 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 … 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. 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,” Linthwaite continued. “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.”