Precision diagnostics company IncellDx announced on Wednesday that its incellKINE Long COVID in vitro diagnostic has received a CE-IVD marking in Europe, the first test of its kind approved for marketing to diagnose patient with Post-Acute Sequelae of COVID-19 (PASC), commonly known as long COVID. The test, which demonstrated greater than 90% accuracy across COVID strains is set to launch this month via “one of the world’s largest providers of diagnostic services,” the company said in a press release announcing the approval.
“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 [this] month,” said Bruce Patterson, MD, CEO of IncellDx in a prepared statement. “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 need to accurately diagnose patients with long COVID has been pressing, as a significant portion of the population who have contracted acute COVID-19 experience lingering symptoms that may last a year of more. According to estimates from the World Health Organization, long COVID affects as many as 20% of people who have contracted acute form and another study by 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. In April, the European Commission estimated that between 60% and 80% of people in the EU had been infected with COVID, making long COVID a significant public health issue.
But clinicians have been faced with a difficult task when it comes to definitively diagnosing long COVID. Many of it symptoms, including fatigue, brain fog, shortness of breath, insomnia, and a wide range of cardiovascular issues, are also indicative of other conditions like post-Lyme, ME-CFS, Fibromyalgia, and even the common cold.
“Long COVID presents a significant diagnostic and treatment challenge for patients,” Patterson added. “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 test leverages artificial intelligence and machine learning algorithms to measure and analyze levels of cytokines and chemokines—inflammatory biomarkers of long COVID. The company published the results of its research in the journal Frontiers in Immunology showing that patients with a prior COVID-19 infection who had lingering symptoms had distinct immunological profiles that were characterized by patterns of inflammatory biomarker expression. Further research published by the company found the SARS-CoV-2 spike protein monocytic reservoirs of long COVID patients up to 15 months after acute infection.
“With an estimated 200 million worldwide suffering and established negative impact to health systems and economies in Europe, the U.S., India and South America, long COVID is already becoming the world’s next global public health crisis,” Patterson concluded. “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.”