IncellDx has received CE-IVD marking for its incellKINE Long Covid In Vitro Diagnostic test in Europe.
This marking will allow the company to formally launch the test in countries that accept the designation in September.
It is claimed to be the first diagnostic test designed for identifying patients with long Covid.
The test identifies immune signatures that are unique to long Covid and helps distinguish it from other diseases with similar symptoms.
The incellKINE blood test helps in the objective diagnosis of patients with Post-Acute Sequelae of Covid-19 (PASC), which is commonly called long Covid.
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The company stated that the test will be launched through a strategic partnership with a leading laboratory diagnostic services provider.
IncellDx CEO Bruce Patterson said: “With so many people in Europe and around the world suffering from ongoing symptoms of Covid, without a diagnosis available to confirm long Covid, we are very pleased to receive the CE Mark and to be launching long Covid testing in Europe next month.
“Together with the support of our own studies to better understand the underlying cause of long Covid and a validation study from a respected global reference lab, this CE-IVD mark provides additional validation of the quality and reliability of this diagnostic.”
The incellKINE test is claimed to provide more than 90% accuracy, and its performance is not affected by the emergence of different Covid-19 variants.
The test was developed based on clinical studies. IncellDx researchers produced objective disease scores for long Covid by using machine learning and artificial intelligence to measure and analyse sets of inflammatory markers called cytokines and chemokines.
The findings from the studies also showed that individuals with earlier Covid-19 infection and persistent symptoms had a unique immunologic profile characterised by patterns of inflammatory marker expression.
The company also found the SARS CoV-2 S1 spike protein in the monocytic reservoirs of long Covid patients up to 15 months after acute infection.