The first diagnostic designed to identify patients with Long Covid has received CE-IVD marking in Europe, meaning it is ready for its formal launch in countries accepting the designation this month. It works by looking for “patterns of inflammatory marker expression” in the blood, and in particular for the Covid spike protein persisting in white blood cells. Business Wire has the story.
The simple blood test can help to objectively diagnose patients suffering from Post-Acute Sequelae of COVID-19 (PASC), commonly known as Long Covid. Developed by IncellDx, the test will be available to prescribers and patients in September through one of the world’s largest providers of diagnostic services.
A CE Mark indicates that the incellKINE Long Covid In Vitro Diagnostic fulfills the requirements of relevant European product directives and meets all the requirements of the relevant recognised European harmonised performance and safety standards…
The CE marking is supported by data from a validation study conducted by one of the world’s largest providers of diagnostic services, showing the test provides greater than 90% accuracy across Covid strains. The test was developed based on clinical studies published in the peer reviewed journal Frontiers in Immunology, which showed that IncellDx researchers generated credible, objective disease scores for Long Covid using machine learning and artificial intelligence to measure and analyse sets of inflammatory markers called cytokines and chemokines. The studies also demonstrated that patients with previous COVID-19 infection and lingering symptoms were found to have a distinct immunologic profile characterised by patterns of inflammatory marker expression. In a subsequent publication, IncellDx found SARS CoV-2 S1 spike protein in monocytic reservoirs of Long Covid patients up to 15 months after acute infection. These papers can be found here and here