The First Diagnostic Test for Long COVID Will Formally Launch in Europe in September
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.
About IncellDx
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.
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20220831005242/en/
Contact information
Devin Osting at devinosting@ententeinc.com
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
IonQ och QuantumBasel förlänger sitt långsiktiga samarbete till nästa generations kvantsystem20.12.2025 21:32:00 CET | Pressmeddelande
IonQ (NYSE: IONQ), världens ledande kvantdatorföretag, tillkännagav i dag ett utökat samarbetsavtal med QuantumBasel, kvantinitiativet vid uptownBasel, Schweiz internationella innovationscampus. Genom det utökade avtalet beviljas QuantumBasel äganderätten till det befintliga IonQ Forte Enterprise-systemet och blir ägare av ett nästa generationens Tempo-system. Det nya avtalet ökar det totala värdet av samarbetet mellan QuantumBasel och IonQ till över 60 miljoner USD samtidigt som IonQ:s roll i Schweiz därigenom förlängs i ytterligare fyra år, t.o.m. 2029. QuantumBasel är IonQ:s officiella innovationscenter i Europa och fungerar som ett nav för europeiska industrier, universitet och forskningsinstitut som vill utforska praktiska kvantdatortillämpningar och få tillgång till IonQ:s senaste storföretagssystem. ”Vårt förlängda samarbete med QuantumBasel utgör en hörnsten i IonQ:s globala strategi”, säger Niccolo de Masi, styrelseordförande och CEO på IonQ. ”QuantumBasel fortsätter att vara
EIG Acquires a 49.87% Stake in Transportadora de Gas del Perú (TgP)19.12.2025 18:42:00 CET | Press Release
EIG, through its managed investment vehicles, acquired a 49.87% equity stake in Transportadora de Gas del Perú S.A. (“TgP”) from Canada Pension Plan Investment Board today. TgP operates Peru’s principal natural gas and natural gas liquids pipelines under a long-term concession, supplying approximately 40% of the country’s power generation. “We are delighted to complete this transaction and embark on the next chapter of our partnership with TgP,” said Matt Hartman, EIG’s Global Head of Infrastructure. “Our priority is to support TgP’s operational excellence and long-term stability, delivering value for customers and stakeholders throughout Peru.” About EIG EIG is a leading institutional investor in the global energy and infrastructure sectors with $24.3 billion assets under management as of September 30, 2025. EIG specializes in private investments in energy and energy-related infrastructure on a global basis. During its 43-year history, EIG has committed over $51.7 billion to the energ
Klarna Partners With Coinbase to Add Stablecoin to Funding Mix19.12.2025 18:00:00 CET | Press Release
Klarna, the global digital bank and flexible payments provider, has partnered with Coinbase to add stablecoin funding to its broad range of traditional sources of funding, which include consumer deposits, long-term loans and short-dated commercial paper. The digital bank plans to raise short-term funding from institutional investors denominated in USDC utilizing Coinbase’s digitally native infrastructure. Adding a USDC-denominated funding source enables Klarna to access USD-like funding directly, tapping into a new pool of institutional investors. “This is an exciting first step into a new way to raise funding,” said Niclas Neglén, Chief Financial Officer, Klarna, “Stablecoin connects us to an entirely new class of institutional investors, and gives us the potential to diversify our funding sources in ways that simply weren't possible a few years ago. This is just the beginning of how digital assets can work alongside our traditional funding sources." Klarna chose Coinbase for this ini
CyberArk Named a Leader in IDC MarketScape: Worldwide Integrated Solutions for Identity Security 202519.12.2025 17:00:00 CET | Press Release
CyberArk (NASDAQ: CYBR), the global leader in identity security, today announced that it has been recognized as a Leader in the IDC MarketScape: Worldwide Integrated Solutions for Identity Security 2025 Vendor Assessment. CyberArk extends dynamic privilege controls across all identity types with its unified platform, enabling organizations to improve efficiencies and streamline security operations. This IDC MarketScape report notes, “More change has occurred in the identity security marketplace in the past two years than in almost a decade. Vendors are entering a new phase defined by the emergence of intelligence technologies, none of which are specifically defined by any industry standards. Though different by design, the new adjacent IAM offerings are largely focused on improved vulnerability and threat management visibility and automated and predictive attack detection capabilities.” It also notes, “By addressing these evolving identity types within a unified framework, CyberArk enh
New York Liberty and Ant International’s Alipay+ Announce Multiyear Partnership Focused on Empowerment, Sustainability and Youth Development19.12.2025 14:30:00 CET | Press Release
The New York Liberty and Ant International’s Alipay+, a leading cross-border fintech services platform based in Singapore, today announced a multiyear partnership, making Alipay+ an Official Sponsor and Innovation Partner for Sustainability of the New York Liberty. Through this partnership, Alipay+ and the Liberty will jointly support community programs designed to advance community empowerment, environmental sustainability and youth development across New York City. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251219678825/en/ Peng Yang, CEO, Ant International and Clara Wu Tsai, Vice Chair, Brooklyn Sports and Entertainment; Governor, New York Liberty “Our partnership with Alipay+ goes beyond the game,” said Keia Clarke, Chief Executive Officer, New York Liberty. “Together, we are investing in the future of New York—its people, its environment, and its youth. Ant International’s commitment to community empowerment, sustai
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom