SOUTH SAN FRANCISCO, Calif., Nov. 17, 2020 (GLOBE NEWSWIRE) -- Fluidigm Corporation (NASDAQ:FLDM), an innovative biotechnology tools provider with a vision to improve life through comprehensive health insight, today announced COVID-19 Community Connect, a program to link federal, state and local governmental entities, public health agencies, academic institutions, workforces, individuals and a network of high-complexity labs to deliver saliva-based COVID-19 testing.
As demand for noninvasive saliva-based COVID-19 testing increases, Fluidigm is serving as a hub to connect interested communities with testing providers.
“Since announcing our Emergency Use Authorization for saliva-based PCR testing in late August, we have seen tremendous interest in our testing technology,” said Chris Linthwaite, Fluidigm President and CEO. “We created the Community Connect program to organize a system for assessing needs, recruiting lab partners and building a service ecosystem for delivering timely results. This model is proving to be an effective and scalable way to get the greatest number of our saliva-based COVID-19 tests to critical populations in communities across the United States.
“We have seen healthy adoption and growing demand for saliva-based testing with strong new instrument placements in clinical labs and public health and academic medical centers,” continued Linthwaite. “With many of the inquiries we receive, the community seeking our saliva test does not have access to appropriate lab facilities. To address this need, we developed the Community Connect program to match demand with testing supply. One example of this partnership model is an award to a partner testing lab for testing services around the federal surge testing effort under the U.S. Department of Health and Human Services Community-Based Testing Site program.
“We have been building a network of partner labs for a number of weeks, and we welcome additional partners as well as general inquiries from groups seeking reliable, cost-effective and easy-to-administer tests.”
In late August, Fluidigm received Emergency Use Authorization from the U.S. Food and Drug Administration 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 clinical study submitted to the FDA demonstrated 100 percent agreement between saliva results from the Advanta assay and results from paired nasopharyngeal samples tested with authorized assays.
As an example of the types of connections Fluidigm is creating, Phase2 Labs of Nashville, Tennessee, has adopted the Advanta assay to market COVID-19 testing services to corporate and governmental entities, nursing facilities and on-location film crews.
“Phase2 is honored to collaborate with Fluidigm and other trusted partners to provide critically needed testing capacity to a range of organizations relying on COVID-19 tests to make strategic decisions about safety,” said Steven E. Kress, co-founder and CEO of Phase2 Labs.
“The saliva-based approach offers a simple, accurate, pain-free option for PCR COVID-19 testing, and Phase2 can deliver results within 24 to 48 hours. Based in Nashville, we’re within close reach of half the U.S. population, enabling us to be vital community partners in making a meaningful difference in this health crisis.”
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 that CLIA laboratories can combine with commonly available automation platforms.
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.
The Fluidigm RADx project is supported by the NIH Rapid Acceleration of Diagnostics initiative and has been funded in whole or in part with federal funds from the National Institute of Biomedical Imaging and Bioengineering, National Institutes of Health, Department of Health and Human Services, under contract No. 75N92020C00009.
Learn more about COVID-19 Community Connect: go.fluidigm.com/community-connect