Fluidigm Obtains European CE Mark approval for Advanta Platform

Fluidigm, a diagnostics company using microfluidics technology and working in the area of disease diagnostics has seen its fortunes go through wild swings in the past year during the Coronavirus pandemic. Today, the company announced via press release the approval of a CE marking for its Advanta platform. For sales in Europe, this is a major step. 

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. Intended Use The Advanta™ Dx SARS-CoV-2 RT-PCR Assay is a reverse transcription (RT) and real-time polymerase chain reaction (PCR) test intended for the qualitative detection of nucleic acid from SARS-CoV-2 in saliva from patients who are suspected of COVID-19.

Analysis: This indicates the opening of a new market in Europe, and sales associated this. Read more on it here: https://investors.fluidigm.com/news-releases/news-release-details/fluidigm-receives-ce-ivd-mark-its-saliva-based-advanta-dx-sars

More on the CE marking: https://europa.eu/youreurope/business/product-requirements/labels-markings/ce-marking/index_en.htm