Your Support is Needed to Validate Long Covid Biomarkers

9/5/24 Announcement

The LC Biomarkers Go Fund Me has ended as Dr. Johan Van Weyenbergh and his team will have all the money he needs for the research we have discussed in this GFM based on recent developments. We will have a detailed announcement for the community shortly.

*** $15,000 in matching funds have been received. $5,000 through this GFM & $10,000 contributed alternatively, thus the goal amount has been reduced to $140,000.

through July 31, 2024. Donate now! All United States Donations are tax deductible.

LCAP and Long COVID Foundation are excited to announce a chance for the community to fundraise and help validate a non-invasive Long Covid Biomarkers* test capable of FDA approval for clinical use and trials. With help from our grassroots activism, researchers in Belgium will be able to use donations gathered by this campaign to externally validate a set of universal Long Covid biomarkers for immune changes and SARS-CoV-2 viral persistence.

This research is nothing short of a miracle for those of us who’ve developed Long Covid and waited years for biomarkers.

image caption: Images show Graphs A/B/C that visualize the viral (antisense RNA) and immune (FYN) Long Covid Biomarkers from the Long Covid Transcriptomic study: Transcriptome analysis of immune response and SARS-CoV-2 transcripts and their association with patient-reported outcomes in long COVID

*Read the Transcriptomic Study published in Lancet

Background

In 2024, Dr. Johan Van Weyenbergh, and his team of researchers, published a groundbreaking paper outlining results of a blood test that could identify Long Covid with 92% certainty using transcriptomic testing equipment that is widely available and can be FDA approved. The current test used in the study processes 800 genes to measure RNA viral load of SARS-CoV-2 and immune RNA at a cost that is roughly $400-$600 per sample. Your donations to this campaign will fund the second round of testing to validate the results discovered in Dr. Van Weyenbergh's research. This validation round will bring the research closer to FDA approval by funding over 100 additional tests from samples in the USA, UK, and France to be published in a new paper.

If our grassroots fundraising is successful, Dr. Van Weyenbergh believes the validated non-invasive biomarkers could be limited to a test of 50 genes, reducing the total cost of each sample in the future to $50-$100. This would radically change the ability of the NIH to run affordable validated biomarker tests in ongoing RECOVER trials and independent studies, as well as open access to more affordable Long Covid tests in clinical settings.

Johan Presenting The Lancet Study Discoveries

Long Covid Biomarkers Campaign FAQ

The following are answers to questions about the Long Covid Biomarkers Campaign on GoFundMe which is raising funds for a scientific study to validate Long Covid Biomarkers.

Q. How are donations from the GoFundMe campaign being used?

A. 100% of the $150K raised, even if the amount is less than $150K, will go to the researchers for the purpose of validating the discovery of Long Covid Biomarkers (minus GoFundMe’s fees and 5% required for the university). Any additional funding beyond the $150K will be used by LCAP and LCF for actions involving FDA approved Long Covid biomarkers.

It’s also important to note that the distribution of funding, as well as the promise of research work, is contractually agreed to by LCAP, LCF, and the researcher. The organizational partner responsible for distributing funding to the researcher voted unanimously in favor of partnering on this project with LCAP & LCF.

Q. What about the problem of cost and availability for this biomarker test? We need this to be readily available and cheap!

A. The current blood test processes up to 800 genes to measure RNA viral load of SARS-CoV-2 & a large set of immune RNA at a cost of $400-$600/sample. But the future validated non-invasive biomarkers test of 50 genes would be possible for a total cost $50-$100 per sample. (answered by Dr. Johan Van Weyenbergh)

Q. What does the test detect?

A. The panel detects many more viral RNAs than just Spike. It detects RNAs from several portions of the virus (called by their order in the genome ORF1, ORF3, ORF7, Spike, Nucleocapsid) and antisense RNA made by replication inside an infected cell. This test is made to detect SARS-COV2 infection in combination with a broad picture of the immune response. (answered by Dr. Johan Van Weyenbergh)

Q. Why is the initial study size only 12 healthy cohorts and 48 LC cohorts? Is this enough? Is the new study of over 100 samples enough to validate the LC biomarkers?

A. The platform we use for the test (nCounter equipment from Nanostring Technologies) uses a type of “cartridge” on which exactly 12 samples fit, hence the multiples of 12 in both patients and controls. This first Belgian cohort had 48 LC patients analyzed (quite similar to several LC publications), to which we then had to carefully match the controls (from the same general practice) for age, sex, time since acute COVID, vaccine status and number of comorbidities, which was unique to our study and explains the lower number of controls. Statistically speaking, this was sufficient for a first study, usually called a ‘discovery cohort’. We now need a second study to validate these findings in an external so-called ‘validation cohort’ (preferably not from Belgium so our biomarkers can hopefully be used worldwide). We aim for over 100 samples, 48 LC patients again, more matched controls (48 people recovered from acute COVID without LC) and a small number of other controls (negative and positive controls, which could include patients suffering from ME/CFS, multiple sclerosis or other neuroinflammatory disorders). Statistically speaking, this will be enough to validate the biomarkers. (answered by Dr. Johan Van Weyenbergh)

Q. Does graph C in the initial study mean that people all have the same results below the line and wouldn’t that mean that the test won’t be able to see the differences? Will these mean the test won’t accurately detect who has or doesn’t have LC?

A. Graph C shows that up to two thirds of LC patients have viral RNA above the red line. But we also include the immune response to get a complete picture. The biomarker proposed for LC is a combination of antisense SARS-CoV-2 combined with FYN RNA (an immune molecule higher in LC patients), This is shown in panel A and B of the publication. This combination has >90% specificity (accuracy) to distinguish patients from controls. (answered by Dr. Johan Van Weyenbergh)

Q. What are the credentials of the head researcher – how can I find out more about their work?

Johan Van Weyenbergh has a public profile on Researchgate Johan Van Weyenbergh, Google scholar ‪Johan Van Weyenbergh‬, KU Leuven Johan Van Weyenbergh — Laboratory for Clinical and Evolutionary Virology (kuleuven.be) , X @johanvawe and LinkedIn (29) Johan Van Weyenbergh | LinkedIn (answered by Dr. Johan Van Weyenbergh)

Q. Is this all or nothing? What happens if we don’t raise the full $150,000 & only $30K is raised – what do we get for that investment?

A. The number of samples analyzed are proportional to the amount raised, so even with 30-50K we can make a nice start with the validation effort. (answered by Dr. Johan Van Weyenbergh)

Q. What is the FDA part of this process for establishing Long Covid Biomarkers?

A. The FDA provides information about qualified biomarkers and the process involved here. (answered by LCAP)

Q. What other info is available about Johan and the Long Covid transcriptomics research?

A. You can find a link to Johan’s presentation during the “Unite to fight” conference on these transcriptomic biomarkers (which he tentatively called “anti-stigma” biomarkers) here: Johan Van Weyenbergh: Patient-Driven Long COVID Clinical Trial (UniteToFight2024 Day 1, Block 1) (youtube.com) (answered by LCAP)

Organizational Statement

LCAP and Long COVID Foundation believe this campaign solidifies how essential grassroots activism is to Long Covid research. Once we come together and meet our fundraising goal the community’s work will help inform trials to develop treatments to save lives in the future. If our efforts are successful, and Dr. Weyenbergh’s research is validated, we will call on the FDA to recognize the first qualified biomarkers for Long Covid. Our follow-up actions will work with the FDA to establish an approved Long Covid Test available for public use. The Long Covid Biomarkers Campaign is an essential investment towards the development of critical and effective treatments. Our heartfelt thanks to all of you for contributing in your own way to this campaign.

For more about this campaign you can check out our latest updates below or on LongCovidBiomarkers.com.

For press inquiries please contact Joshua Pribanic (LCAP) at joshua[at]publicheraldstudios[dot]com, and Devin Russell (Long Covid Foundation) at info[at]longcovidfoundation[dot]org.

***

Long Covid Action Project (LCAP) is a united, diverse force of non-partisan individuals taking action to end the Long COVID crisis. We demand urgent treatment and support for the Long COVID community by mobilizing public awareness and driving government accountability.

Long COVID Foundation’s mission is to bring awareness to the public regarding Long COVID & other pandemic related issues, advocate for better testing, trials, & treatments for Long COVID, and take action in assisting COVID Long Haulers, and others affected by the pandemic. Long COVID Foundation Inc. is tax exempt under Internal Revenue Code section 501(c)(3). EIN 933724191.

Watch this video to learn more about the importance of Viral Persistence

Header photo: A person holds a sign in front of the Lincoln Memorial during the LCDC demonstration in Washington D.C. on March 15, Long Covid Awareness Day. The sign reads, "I'm here because BOTH of my daughters have Long Covid. More research $$ Now!!" Organizers for the event responded with "“HEAL”, i.e. three Long Covid legislative proposals modeled on bipartisan bills that effectively tackle viral persistence." An action letter has being delivered to Senator Bernie Sanders office calling for HEAL to be adopted into law. Activists who helped organize the LCDC event have now launched a Long Covid Biomarkers campaign to fund research for validating the first biomarkers capable of identifying Long Covid and measuring viral load and immune changes.

© Joshua Boaz Pribanic for Public Herald