First test for long Covid gets EU approval, August 2022 - IncellDx incellKINE Long COVID test

John Mac

John Mac

Senior Member (Voting Rights)
Post copied from the Long Covid in the media thread.
See also this thread:
USA: InCellDx Dr Patterson - New lab service offering cytokine tests to Covid longhaulers
____________

The First Diagnostic Test for Long COVID Will Formally Launch in Europe in September

The IncellDx incellKINE Long COVID In Vitro Diagnostic Receives European CE Marking for Its In Vitro Diagnostic (IVD) for Long COVID

  • The simple blood test detects immune signatures specific to long COVID, enabling it to differentiate long COVID from other diseases with similar symptoms.

  • The test will be launched in September through a strategic partnership with a leading provider of laboratory diagnostic services.

  • The test provides greater than 90% accuracy, based on validation studies; test performance is not affected by emergence of different COVID-19 variants.
SAN CARLOS, Calif., August 31, 2022--(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.
Click to expand...

https://uk.finance.yahoo.com/news/first-diagnostic-test-long-covid-070000516.html
 
Last edited by a moderator:
Merged thread

  • The Scottish Mail on Sunday
  • 4 Sep 2022
  • By Jonathan Neal
THE first blood test for long Covid has been approved by European regulators, raising hopes for the millions of Britons suffering from the debilitating condition.

Trials have shown the test detects immune system cells specific to long Covid, helping doctors to differentiate it from other diseases with similar symptoms.

The incellKINE Long Covid In Vitro Diagnostic test has now received a CE mark, giving it approval for use in the European Union, after authorities accepted data from a study suggesting it was more than 90 per cent accurate across all Covid strains.

Dr Stephanie de Giorgio, a Kent GP focused on tackling long Covid, cautiously welcomes the test.

She says: ‘One of the problems that will remain is that we don’t have any treatments. But if this proves effective, it could give people some answers as to why they feel so rubbish.’

Its maker, IncellDx, plans to launch the test in Europe this month but will need to seek approval from UK watchdog, the Medicines and Healthcare

‘It could tell people why they feel so rubbish’

Products Regulatory Agency, before it can go on sale here.

Prevalence of long Covid is increasing in the UK and Europe – the World Health Organisation estimated that up to one in five patients infected with the virus go on to suffer a variety of mid- and long-term effects after recovering from the initial illness.

Commonly reported symptoms include fatigue, breathlessness and brain fog.

Figures from the Office for National Statistics last week showed an estimated two million people – roughly three per cent of the population – were reporting problems lasting for more than four weeks after initial infection.

Of those, 22 per cent said their symptoms had persisted for at least two years. Despite this, the condition is little understood.

Dr Bruce Patterson, the chief executive of California-based IncellDx, says: ‘Long Covid presents a significant diagnostic and treatment challenge.’

Many of the symptoms, he adds, which include a wide range of cardiovascular issues, can easily be mistaken for painful conditions such as post-treatment Lyme disease syndrome, myalgic encephalomyelitis/chronic fatigue syndrome, fibromyalgia or even the common cold.

He adds: ‘Having an effective and objective tool to diagnose long Covid is absolutely essential.’
Click to expand...

taken from pressreader
https://www.pressreader.com/
 
Last edited by a moderator:
Many of the symptoms, he adds, which include a wide range of cardiovascular issues, can easily be mistaken for painful conditions such as post-treatment Lyme disease syndrome, myalgic encephalomyelitis/chronic fatigue syndrome, fibromyalgia or even the common cold.
Click to expand...

Really?

This is a 'fact' is it?

I have other 'objections' to this paragraphs assertion but.....maybe I have the sniffles.
 
This seems a bit out of nowhere - I've heard of the man and the company but not in the context of anything produced being 'nearly there'. Then suddenly something suggesting a regulator is taking the 90% effectiveness claim as correct. What have I missed? does the 'Kine' bit assume they are looking for cytokines or something?
 
My concerns are generally the lack of validation. It seems like the test was developed using machine learning. When you do this, you should have two cohorts--one for training, another for validation, to guard against overfitting (classifying data based on coincidences in the particular dataset you're studying). But they used only one. I also haven't seen evidence it can distinguish between long Covid and other conditions. It's a test of immune markers, so people with autoimmune diseases unrelated to LC or ME might get false positives.

Thus, my hopes are modest. Maybe the test is half-decent after all, and will be better-validated later. Maybe its arrival will increase interest in biomarkers and lead to development of a better one. I don't know. But my gut says this is a development, even if it's an overhyped one.
 
Hubris said:
Isn't Patterson the guy who claims to have cured something like 6000 patients yet not a single anecdote was to be found anywhere? Surely institutions are not falling for this garbage are they?
Click to expand...

Yes he is. I have seen a bunch of people on the longhaulers sub talking about the results they got and the treatment, none has said it cured them so far. Patterson claims it distinguishes between LC and ME/CFS and other conditions but I haven't seen a paper to that effect yet. If he was curing so many people I would have expected it being shouted hard on the long haulers sub, but its not those that recover have done so slowly and naturally like most post viral sufferers and those that haven't are stuck like pwME. We would be hearing a lot more buzz around something that has cured so many that wasn't from the organisation itself.
 
Last edited:
RedFox said:
My concerns are generally the lack of validation. It seems like the test was developed using machine learning.
Click to expand...

There is a deeper problem with this approach. The gold standard for machine learning is the existing clinical diagnosis. If all the test does is come up with the same population, clinical diagnosis is just as good. And if clinical diagnosis is not considered reliable then the test is not reliable either.

Diagnostic tests are useful to the extent that they provide some sort of explanation that adds confidence to the clinical diagnosis or that they can predict the development of a clinical diagnosis. The latter does not apply here. A good test is not one that correlates best but one the picks out the cases that do not fit and explains why. A machine learning based algorithm almost by definition does not provide any explanation - it is just what the computer spits out.
 
There are two primary ways to use machine learning, tagged or untagged data. With tagged data you would be taking positive results and negative ones determined manually and ensuring it correctly identified which is which through the training. I suspect this is using untagged data where the machine learns groupings based on the data and then Patterson's team assigns a tag to the groups as to whether is positive or not for the condition. The untagged approach is going to be hard to accept in most medical fields I think, places like Netflix used it quite successfully for finding new categories for movies and TV (but they don't expose them as they make no sense to viewers) but medically its backwards compared to what people are used to. The issue we have with a lot of machine learning based research at the moment is a lack of access to the code and the models to replicate results and often they aren't made available even on request. Papers based on this can't be considered high quality as a result. Hopefully the authorities at least have assessed it appropriately and have all the pieces they need to replicate the results. A diagnostic test would be wonderful and I think it will change the fate of the condition dramatically.
 
Andy said:
ME Association: New Test For Long Covid

"The Times reports on a diagnostic test from US-based diagnostics company IncellDx which claims to detect Long Covid and can distinguish between this and ME/CFS. The article is behind a paywall but can be accessed from the link below, https://www.thetimes.co.uk/article/...elldx-blood-treatment-symptoms-2023-hjz3rgdq0"

https://meassociation.org.uk/2023/02/new-test-for-long-covid/

Also reports on comments on the test from a certain Jonathan Edwards.
Click to expand...

The author is Francesca Steele who has previously written about (ie, advertised) the Lightning Process for LC.
 
You must log in or register to reply here.
Back
Top Bottom