Fluidigm COVID-19 Community Connect Program Builds a Network of Testing Partners to Increase Access of Saliva-Based SARS-CoV-2 Testing for Communities - Seite 2

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

Intended Use
The Advanta Dx SARS-CoV-2 RT-PCR Assay is a real-time reverse transcription (RT) PCR test intended for the qualitative detection of nucleic acid from SARS-CoV-2 in saliva specimens collected without preservatives in a sterile container from individuals suspected of COVID-19 by their health care providers. Testing is limited to laboratories that are certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, and meet requirements to perform high-complexity tests. Results are for the identification of SARS-CoV-2 RNA. The SARS-CoV-2 RNA is generally detectable in saliva specimens during the acute phase of infection. Positive results are indicative of the presence of SARS-CoV-2 RNA; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Laboratories within the United States and its territories are required to report all results to the appropriate public health authorities. Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. Negative results must be combined with clinical observations, patient history and epidemiological information. Negative results for SARS-CoV-2 RNA from saliva should be confirmed by testing of an alternative specimen type if clinically indicated. The Advanta Dx SARS-CoV-2 RT-PCR Assay is intended for use by qualified and trained clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR and in vitro diagnostic procedures. The Advanta Dx SARS-CoV-2 RT-PCR Assay is only for use under the Food and Drug Administration’s Emergency Use Authorization.