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First Diagnostic Test for Long COVID Receives CE-IVD Marking

by | Aug 31, 2022 | News, Open Content

Based on validation study data, the test offers 90 percent accuracy and is unaffected by the emergence of new COVID-19 variants.

California-based precision medicine company IncellDx announced today that it has been granted CE-IVD marking in Europe for its simple blood test that diagnoses long COVID. The company says it plans to launch the test this September in countries accepting the CE-IVD designation via “a strategic partnership with a leading provider of laboratory diagnostic services.”

The incellKINE test, which IncellDx claims is the first to diagnose long COVID, is able to differentiate long COVID from other illnesses by detecting immune signatures specific to the condition. It is also unaffected by the emergence of new COVID-19 variants, IncellDx adds. Developed based on clinical studies published in Frontiers in Immunology, the test’s CE marking was supported by data from a validation study showing that the test provides more than 90 percent accuracy, the company said in a press release.

Challenges with Long COVID Diagnosis

While most people recover from COVID-19 within weeks at the very most, about 10 percent develop long-term symptoms such as fatigue, muscle pain, and brain fog, according to research on COVID-19 symptoms. Diagnosing long COVID is difficult because healthcare providers must first confirm that someone was infected with COVID-19 in the first place, then rule out conditions with similar symptoms using a variety of tests such as chest X-rays, heart rate checks, and/or blood tests. Guidelines for diagnosing the condition are based on the best available evidence from studies done so far, which is likely to change as researchers continue to learn more about the disease.

However, until today, there hadn’t been one single test that could diagnose long COVID, though other options are in development, including blood tests similar to the incellKINE test that target biomarkers associated with long COVID-19. Researchers are also working on groups of tests that look for signs of vascular damage caused by COVID-19 infection. The CE marking and planned launch of the incellKINE test is thus an important step to bringing a single long COVID test to patients.

Long COVID in Europe

With as much as 80 percent of the European Union estimated to be affected by long COVID, the test could help millions get an accurate diagnosis and the correct treatment for the condition, IncellDx adds.

“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 [m]ark, and to be launching long COVID testing in Europe next month,” said Bruce Patterson, MD, CEO of IncellDx, in a press release. “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.”