SAN CARLOS, Calif.--(BUSINESS WIRE)--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.
Patterson added, “Long COVID presents a significant diagnostic and treatment challenge for 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. Having an effective - and importantly an objective - tool to diagnose the condition is absolutely essential. An objective test that can detect immune signatures specific to long COVID is vital for effective diagnosis and to enable patients to seek effective treatment.”
The prevalence of long COVID is thought to be increasing across the UK and Europe, with significant impact both to individuals and to the economy. In April the European Commission said that between 60 percent and 80 percent of the EU population was estimated to have been infected with acute COVID-19, while the World Health Organization estimates long COVID affects up to 20 percent of patients infected with acute COVID. A recent study from the Luxembourg Institute of Health found that six in 10 patients had at least one persistent COVID-19 symptom, and that patients whose symptoms have not resolved by 15 weeks are likely to experience symptoms for at least a year. One in seven participants indicated that they “couldn't fathom coping with their symptoms long term.” Another study published in May in the Lancet medical journal found that two years after infection, half of people hospitalized with COVID-19 still have at least one symptom. In these studies, the most common symptoms were fatigue, shortness of breath, and irritability.
“With an estimated 200 million worldwide suffering, and established negative impact to health systems and economies in Europe, the US, India and South America, long COVID is already becoming the world’s next global public health crisis,” Patterson said. “We are pleased that CE marking was granted for the IncellDx incellKINE long COVID test in Europe, and that the test will be made widely available to physicians and their patients soon.”
Patients who have or think they may have long COVID can learn more and register for a test here.
IncellDx is a precision medicine company advancing novel diagnostics and prognostics to better understand and treat infectious disease and cancer. The company’s innovative technology platform enables simultaneous cell classification and single cell analysis of proteomic and genomic biomarkers. The company launched the Chronic COVID Treatment Center to apply precision medicine approaches to evaluate, characterize and more effectively address chronic COVID.