Fluidigm Corporation (FLDM)’s Advanta Dx Test receives CE-IVD Mark from EU

Today, Fluidigm Corporation (FLDM) grew 20.62% to $7.43 in the pre-market trading session following the declaration from the company that their Advanta DX test has received a CE-IVD mark as it is in line with the in vitro guidelines set by the European Union Directive. The test does not require a nasal swab instead it uses Saliva to detect infection. The company’s clinical studies for submission have resulted in a full 100% showing a natural agreement between saliva and the test.

FLDM‎ focuses on transitional and clinical research including cancer, immunology, and ‎immunotherapy. They create a wide variety of marketable multi-omic solutions and speed up the ‎development of therapies.‎

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The JAMA internal medicine published in their systematic review that the saliva-based tests have similar sensitivity and specificity as the invasive nasal testing. The company believes that its test has done wonders in the US and has finally launched in Europe. Experts believe that the COVID-19 testing will skyrocket from $5billion to $7 billion this year.

Europe has been worse hit by the pandemic and is reporting a million new cases every four days and has amassed over 27 million cases since the pandemic arrived.

The intended use for the test is the detection of nucleic acid from SARS-CoV-2 in saliva from patients who have symptoms of COVID-19. Positive results are indications that the patient is infected by COVID-19 however these results do not rule that the infection is bacterial or viral. The test is used by healthcare professionals with having specialization for in vitro diagnostic procedures.

The Advanta DX test is expected to be offered for 5 Euros per test in the EU.


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