Fluidigm Corporation, an innovative biotechnology tools provider with a vision to improve life through comprehensive health insight, has announced a program to expand availability of Fluidigm® COVID-19 tests for U.S. colleges and universities. The Fluidigm COVID-19 Campus Safeguard Program will provide millions of noninvasive, saliva-based tests for the SARS-CoV-2 virus to qualifying institutions at a cost as low as $5 per test.
The Advanta™ Dx SARS-CoV-2 RT-PCR Assay on the high-throughput Fluidigm Biomark™ HD system features an integrated testing platform and a reliable supply chain and can be easily combined with commonly available automation platforms.
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. The assay does not require collection via invasive nasopharyngeal swab. The company’s submission to the FDA demonstrated 100 percent agreement between saliva results from the Advanta Dx SARS-CoV-2 RT-PCR Assay and results from paired nasopharyngeal samples tested with authorized assays.
Development, commercialization and implementation of the Advanta Dx SARS-CoV-2 RT-PCR Assay are supported by a $34 million definitive contract with the National Institutes of Health under the agency’s Rapid Acceleration of Diagnostics (RADx) initiative. The RADx initiative fast-tracks development and commercialization of innovative technologies to significantly increase U.S. testing capacity for SARS-CoV-2.
With the scale-up support, the low-cost, saliva-based Advanta Assay will be targeted to all universities and colleges across the United States. Many higher education systems are struggling to deploy affordable testing programs to serve large populations. Fluidigm has a large number of Biomark HD placements in academic clinical laboratories in the United States that meet requirements to perform high-complexity tests in significant numbers.
Many pioneering higher education institutions and labs across the United States, including the University of Pennsylvania, Washington University in St. Louis, OU Medicine, the University of Oklahoma and the Oklahoma Medical Research Foundation (OMRF), have chosen to use Fluidigm microfluidics technology and reagents to test individuals for the SARSCoV2 virus.
“Fluidigm microfluidics enables a tool for testing in a rapid and affordable format,” said Joel Guthridge, PhD, Director, Translational Informatics & Clinical Research Resources at OMRF. “This approach allows us to identify positive individuals and quickly assess potential exposures and risk with the goal of keeping our employees and students and their families safer.”
“There are many reasons why high-throughput, saliva-based PCR testing for SARS-CoV-2 virus detection is a powerful tool for colleges and universities,” said Chris Linthwaite, Fluidigm President and CEO. “Fluidigm’s saliva-based PCR test combines an affordable, kitted solution with sample collection that is far easier as compared to invasive swabs, and often preferable for both the health care providers collecting samples and the students and staff being tested. Our test has demonstrated 100 percent agreement with paired samples from authorized nasopharyngeal assays. While antigen testing can be an important element of pandemic response, it is not enough, as PCR virus detection provides greater sensitivity.
“Furthermore, the Fluidigm test avoids supply chain constraints associated with other tests and has received Emergency Use Authorization from the FDA.
“We are grateful for the support of the NIH RADx initiative, which has enabled us to accelerate our production capacity and make the Fluidigm COVID-19 Campus Safeguard Program possible. We will continue to ramp up our capacity, and in the fourth quarter we expect to have six million tests available,” Linthwaite said. “We are excited for this opportunity to play a major role in helping to keep students and staff safe as our nation continues to navigate the global health crisis.”
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