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IncellDx Gets CE-IVD Mark for 'Long COVID' Assay

NEW YORK — IncellDx announced Wednesday it has gained a CE-IVD marking that will allow sales in Europe of a blood test to identify patients with long COVID.

The San Carlos, California-based firm said the IncellKine long COVID in vitro assay will be available in September. The test is used to measure immune system signatures specific to the disease, and IncellDx said validation study results show the test provides greater than 90 percent accuracy across SARS-CoV-2 strains.

IncellDx said the company's published research results showed the ability to create credible and objective disease scores for long COVID by measuring and analyzing levels of cytokine and chemokine inflammatory markers, and company researchers identified distinct inflammatory marker expression patterns among long COVID patients.

"Many of the symptoms that are associated with long COVID, including fatigue, brain fog, shortness of breath, insomnia, and a wide range of cardiovascular issues, can easily be mistaken for other conditions like post-Lyme, ME-CFS, fibromyalgia, or even the common cold," IncellDx CEO Bruce Patterson said. "Having an effective — and importantly an objective — tool to diagnose the condition is absolutely essential."