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

Fluidigm Stock Could end up Sideways for a while

 Disclosure: I have been long on Fluidigm for almost a year and currently hold some in my portfolio,

Fluidigm is a 

Others in the space include Vault Health, a test provider that has contracts with many state governments. They are billing the test at $119 per test, which is the same as the LabCorp $119 test. I have nt done detailed research in this area, but this number might  be the result of government reimbursement limits/caps/profit maximums etc. I did some digging around and it looks like the pricing is a direct result of trying to be competitive to LabCorp's nasal swab (at home sample collection) test.

See: https://finance.yahoo.com/news/vault-reduces-price-home-saliva-140000693.html?.tsrc=fin-srch

Stanford however launched its own low cost saliva-based test and is enrolling 

Fluidigm got its FDA authorization in late August (Opens new window pdf download)

Vault's Original FDA EUA was issued in April and is available for download here (Opens new window).

Other names for Vault's test:

Other Brand Name(s)

• Vault Health COVID-19 Test
• USGC Saliva Test Kit, hims/hers Saliva Test Kit
• BioIQ COVID-19 Saliva Test
• Concentric by Ginkgo
• 1health.io Zero Contact
• Base10 Saliva Test Kit
• Purlab. Saliva Test Kit
• Reliant Saliva Test Kit
• E7 Health Saliva Test Kit
• miinehealth Saliva Test Kit
• Maverick Saliva Test Kit
• SDTL Saliva Test Kit
• AZOVA At-Home COVID-19 Test Collection Ki

https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization