The IncellDx incellKINE Long COVID In Vitro Diagnostic Receives European CE Marking for Its In Vitro Diagnostic (IVD) for Long COVID
- The simple blood test detects immune signatures specific to long COVID, enabling it to differentiate long COVID from other diseases with similar symptoms.
- The test will be launched in September through a strategic partnership with a leading provider of laboratory diagnostic services.
- The test provides greater than 90% accuracy, based on validation studies; test performance is not affected by emergence of different COVID-19 variants.
The first diagnostic designed to identify patients with long COVID has received CE-IVD marking in Europe. It is ready for its formal launch in countries accepting the designation in September of this year. 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 recognized European harmonized performance and safety standards.
“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,” said Bruce Patterson, MD, CEO of IncellDx. “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 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 percent 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 analyze 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 characterized 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.
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