Californian Diagnostics Company, IncellDx Launches First Diagnostic Test For Long COVID-19 In Europe

Long COVID Diagnostics: IncellDx, a company based in California-USA specializing in a precision medicine and an array of advanced novel diagnostics and prognostics for the treatment of various infectious disease and cancer is officially launching the world’s first diagnostic test for Long COVID in Europe this month after securing the CE-IVD marking in Europe.


 
The company’s utilized its innovative technology platforms that enables simultaneous cell classification and single cell analysis of proteomic and genomic biomarkers to develop the IncellDx incellKINE Long COVID In Vitro Diagnostic test kit that is intended for hospital or clinic use only.
 
Dr Bruce Patterson, MD, CEO of IncellDx told Thailand Medical News, “This new simple blood test detects immune signatures specific to long COVID, enabling it to differentiate long COVID from other diseases with similar symptoms.”
 
He further added, “This new test will be launched this month (September 2022) through a strategic partnership with a leading provider of laboratory diagnostic services.
 
Dr Patterson added, “This test provides greater than 90% accuracy, based on validation studies and furthermore test performance is not affected by emergence of different SARS-CoV-2 variants.” (On this note…Thailand Medical News feels slightly uneasy over this claim as emerging studies are showing that different variants do exhibit a slight difference in pathogenesis and hence affects the immune system and various cellular pathways and gene regulation differently! However the test will be usefull as already many ignorant doctors are not able to diagnose Long COVID and are simply refusing to acknowledge it let alone offer proper treatments to patients suffering from it)
 
According to executives at IncellDx, “This is the first Long COVID Diagnostics test designed to identify patients with long COVID and that 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. The test will be available to prescribers and patients in September through one of the world’s largest providers of diagnostic services.”
 
The 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.
 
Dr Patterson added, “With so many individuals 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. 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 refer ence lab, this CE IVD mark provides additional validation of the quality and reliability of this diagnostic.”
 
Accordingly, 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 validation 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.
https://www.frontiersin.org/articles/10.3389/fimmu.2021.700782/full
 
Importantly, these research findings demonstrated that individuals with previous COVID-19 infection and lingering symptoms were found to have a distinct immunologic profile characterized by patterns of inflammatory marker expression.
 
In another subsequent study, IncellDx found SARS CoV-2 S1 spike protein in monocytic reservoirs of long COVID patients up to 15 months after acute infection.
https://www.frontiersin.org/articles/10.3389/fimmu.2021.746021/full
 
Dr Patterson commented, “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.”
 
He continued, “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.”
 
Alarmingly, 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.
 
However, 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.”
https://www.lih.lu/en/six-in-ten-people-with-covid-19-still-have-a-least-one-symptom-a-year-later-long-covid-study-reveals/
 
Yet, 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.
https://www.thelancet.com/journals/lanres/article/PIIS2213-2600(22)00126-6/fulltext
 
Interestingly, in these studies, the most common symptoms were fatigue, shortness of breath, irritability, cognitive issues and also other neurological, cardiological and nephrological issues.
 
With estimate that almost 3 billion people globally could by now have been exposed to the SARS-CoV-2 virus and almost 400 million have been re-infected at least once, the number of people that could be suffering from Long COVID globally is phenomenal.
 
Long COVID will contribute to a negative impact to health systems and economies in Europe, the US, India and South America and will likely become the world’s next global public health crisis!
 
Dr 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.”
 
The company also launched the Chronic COVID Treatment Center to apply precision medicine approaches to evaluate, characterize and more effectively address chronic COVID.
 
Thailand Medical News would like to add that besides Immune profiles, biomarkers and even medical imaging to also evaluate the degree of damage and the proper functioning of the heart, liver, kidneys, gastrointestinal tract, brain and CNS along with the  monitoring of upregulated and downregulated proteins and genes, a study of the endocrine system and the various hormone levels are all needed to properly assess the long term issues and health status of a previously COVID-19 infected individual in order to treat Long COVID effectively.
 
Thailand Medical News would also like to warn readers of charlatan groups peddling fake Long COVID remedies and treatment protocols. There is no single drug or product that can treat Long COVID as there are multiple issues at play and treatments have to be focused on the specific issues involved which typically varies from person to person.
 
The protocols being promoted by charlatans like the FLCCC, the Vejon Group and medically untrained individuals setting up so called Long COVID Coalitions and Groups should be avoided and be also reported to regulatory health authorities in your area. Some of these groups also use so called doctors from third world countries whose credentials are questionable!
 
Individuals who think they might have Long COVID and wish to register for these test can access this link for details: https://www.covidlonghaulers.com/patients
 
For the latest on Long COVID Diagnostics, keep on logging to Thailand Medical News.