Fluidigm COVID-19 Campus Safeguard Program Improves Availability of Noninvasive, Saliva-Based SARS-CoV-2 Tests for Higher Education Institutions.
SOUTH SAN FRANCISCO, Calif., Oct. 08, Fluidigm Corporation (Nasdaq:FLDM), 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. (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 Assay and results from paired nasopharyngeal samples.
NIH (RADx) initiative a $34 million contract to fast-tracks development and commercialization technologies to significantly increase U.S. testing capacity for SARS-CoV-2.
The saliva-based Advanta Assay will be targeted to all universities and colleges across the United States.. Fluidigm already has a large number of Biomark HD placements in academic clinical laboratories in 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).
“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. 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.”
In the fourth quarter we expect to have six million tests available,”