Helix Specialty Diagnostics Partners with Genomic LTC DX to Provide COVID-19 Testing with Saliva-Based Advanta Dx SARS-CoV-2 RT-PCR Assay on Biomark HD Platform

Major Midwest Labs Targeting 3,000 Tests per Day

SOUTH SAN FRANCISCO, Calif., Jan. 26, 2021 (GLOBE NEWSWIRE) -- Fluidigm Corporation (Nasdaq:FLDM), an innovative biotechnology tools provider with a vision to improve life through comprehensive health insight, today announced that Helix Specialty Diagnostics is partnering with Genomic LTC DX to provide COVID-19 testing using the Advanta Dx SARS-CoV-2 RT-PCR Assay on the Fluidigm Biomark HD system.

Both Missouri based companies operate major Clinical Laboratory Improvement Amendments (CLIA) certified labs. Helix Specialty Diagnostics leads sample collection for the collaboration, with Genomic LTC DX processing and analyzing the saliva samples via the Advanta Dx Assay on the Biomark HD.

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, and the company’s submission to the FDA demonstrated 100 percent agreement between saliva results from the Advanta Dx Assay and results from paired nasopharyngeal samples tested with authorized assays.

A growing body of peer-reviewed research is confirming that the accuracy of saliva-based COVID-19 testing is comparable to that of nasopharyngeal-based collection. A systematic review and meta-analysis published in JAMA Internal Medicine in January 2021 stated that saliva-based tests have a similar sensitivity and specificity and present an attractive alternative to invasive nasopharyngeal testing.

“Our experience collecting samples and reporting clinical results at scale is further expanded by Genomic LTC DX processing test samples utilizing the Fluidigm assay on the Biomark HD,” said Michael Paulsen, President, Helix Specialty Diagnostics. “High-throughput saliva-based PCR testing is a valuable tool for colleges and universities as well as long-term care facilities, both of which are major customers. We intend to deliver 3,000 tests per day for processing via the Fluidigm system, providing much-needed additional capacity for large-scale testing programs.