George Mason University Providing COVID-19 Testing with Saliva-Based Advanta Dx SARS-CoV-2 RT-PCR Assay on Biomark HD Platform

SOUTH SAN FRANCISCO, Calif., Feb. 10, 2021 (GLOBE NEWSWIRE) -- Fluidigm Corporation (Nasdaq:FLDM), an innovative biotechnology tools provider with a vision to improve life through comprehensive health insight, today announced that George Mason University in Fairfax, Va., is providing saliva-based COVID-19 testing using the Advanta Dx SARS-CoV-2 RT-PCR Assay on the Fluidigm Biomark HD system.

As part of an expansion of testing capacity for GMU students and employees, the university purchased two Biomark HD systems and has equipped labs on the university’s Science and Technology Campus in Manassas, Va., to process the Advanta Dx Assay, with initial plans to run approximately 10,000 tests per week.

“Frequent and reliable testing is the core of our plan to keep students and staff safe at GMU,” said Ali Andalibi, PhD, Professor and Senior Associate Dean in the College of Science at GMU. “Adoption of the Advanta Dx SARS-CoV-2 RT-PCR Assay is one element of a plan to greatly expand our capacity. The noninvasive nature of the assay, accuracy and time to results are among key advantages of the Fluidigm system, which we have combined with an automation platform for testing at scale.

“The testing capacity provided by the Fluidigm system, along with systematic precautionary measures such as masks and social distancing, will help us limit the spread of the virus at Mason.”

Fluidigm has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for the Advanta Dx SARS-CoV-2 RT-PCR Assay, an extraction-free saliva-based test to detect nucleic acid from the SARS-CoV-2 virus in individuals suspected of COVID-19 by their health care providers. The assay does not require collection via invasive nasopharyngeal swab, and the company’s submission to the FDA demonstrated 100 percent agreement between saliva results from the Advanta Dx Assay and results from paired nasopharyngeal samples tested with authorized assays.

A growing body of peer-reviewed research is confirming that the accuracy of saliva-based COVID-19 testing is comparable to that of nasopharyngeal-based testing. A systematic review and meta-analysis published in JAMA Internal Medicine in January 2021 stated that saliva-based tests have a similar sensitivity and specificity and present an attractive alternative to invasive nasopharyngeal testing.