Fluidigm to Offer Millions of Advanta COVID-19 Tests at Low Cost to U.S. Colleges and Universities
Fluidigm COVID-19 Campus Safeguard Program Improves Availability of
Noninvasive, Saliva-Based SARS-CoV-2
Tests for Higher Education Institutions
High-Throughput, Integrated Testing Platform and Reliable Supply Chain
SOUTH SAN FRANCISCO, Calif., Oct. 08, 2020 (GLOBE NEWSWIRE) -- Fluidigm Corporation (Nasdaq:FLDM), an innovative biotechnology tools provider with a vision to improve life through comprehensive health insight, today 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 SARSCoV2 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.