Shares of Fluidigm (NASDAQ:FLDM) were flying 15.3% higher as of 10:55 a.m. EST on Friday. The big jump came after the company announced that it has received the CE-IVD mark for its Advanta Dx saliva-based COVID-19 test.
The "CE" in Fluidigm's CE mark stands for "European conformity" while the "IVD" stands for "in vitro diagnostics." The CE-IVD mark for Advanta Dx means that Fluidigm can now sell its saliva-based test throughout the European Union. Fluidigm has already launched its Advanta Dx test in the U.S. after receiving emergency use authorization in August.
Advanta Dx will be one of the first saliva-based COVID-19 tests to be made available throughout Europe. Fluidigm plans to sell Advanta Dx for as little as 5 euros per test. There's a big opportunity for the company: The total European market for COVID-19 testing this year is projected to be between $5 billion and $7 billion.
The COVID-19 pandemic has provided a big boost for Fluidigm. In the third quarter, the company's sales soared 50% year over year to $39.9 million, with most of that growth driven by COVID-19 testing.
What might be the next major catalyst for the healthcare stock? Probably Fluidigm's next quarterly update. The company is scheduled to announce its fourth-quarter results after the market closes on Feb. 10, 2021.