Fluidigm Receives CE-IVD Mark for Its Saliva-Based Advanta Dx SARS-CoV-2 RT-PCR Assay for COVID-19
SOUTH SAN FRANCISCO, Calif., Jan. 21, 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 the company has received the CE-IVD mark for its 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 CE-IVD mark is in conformance with the European Union In Vitro Diagnostic Directive.
The Advanta Dx SARS-CoV-2 RT-PCR Assay does not require collection via invasive nasopharyngeal swab, and the company’s clinical studies for submission 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.
“Since introduction of our saliva-based COVID-19 testing solution in the United States, we have seen tremendous interest in our testing technology, and we are gratified by the opportunity to offer one of the first saliva-based COVID-19 tests to be widely available in Europe, where the total addressable market for COVID-19 testing, based on third-party and company estimates, is $5 billion to $7 billion in 2021,” said Chris Linthwaite, Fluidigm President and CEO. “The European region is currently reporting a million new infections every four days and has seen more than 27 million cases since the pandemic began.
“In the first phase of the pandemic, we served the European market via home-brew laboratory COVID-19 tests. We are excited for the opportunity to now distribute Fluidigm CE-IVD commercial kits via our direct sales force and distribution partners, including for potential screening applications that may not require an order from a health care provider. We anticipate offering the Advanta Dx SARS-CoV-2 RT-PCR Assay for as little as 5 euros per test, based on volume and other factors.