IncellDx Gains CE-IVD Mark for ‘Long COVID’ Diagnostic

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.