www.fdanews.com/articles/209255-incelldx-gains-ce-ivd-mark-for-long-covid-diagnostic
IncellDx Gains CE-IVD Mark for ‘Long COVID’ Diagnostic
September 2, 2022
San Carlos, Calif.-based IncellDx’s incellKINE in vitro diagnostic test for Long COVID has gained Europe’s CE-IVD mark.
The CE-IVD certification is the first ever for a diagnostic that can identify patients with the condition. The blood test is used to diagnose patients with “post-acute sequelae” following a COVID-19 infection.
In a validation study, the blood test showed more than 90 percent accuracy across COVID strains, the company said.
IncellDx said it plans to launch the test in Europe this month.