www.fdanews.com/articles/206468-pathogendx-gets-ce-mark-for-its-covid-19-test
PathogenDx Gets CE Mark for Its COVID-19 Test
February 7, 2022
Scottsdale, Ariz.-based biotechnology company PathogenDx has received CE mark certification for its Detectx-Cv+ COVID-19 test.
The real-time polymerase chain-reaction test, which detects the DNA of the SARS-CoV-2 virus that causes COVID-19 infection, has a “built-in ability” to detect new mutations and emerging variants, the company said.
The test offers accuracy “equivalent to next-generation sequencing, but with the simplicity of running on standard laboratory equipment,” said PathogenDx CEO Milan Patel.