“We posit that this assay can potentially offer an outstanding biomarker to rapidly and inexpensively diagnose ME/CFS with high accuracy. In addition, this assay may offer a remarkable opportunity for the discovery of new treatments for this debilitating disease.” Esfandyarpour and Davis 2019
In 2019, the nanoneedle was astoundingly accurate in plucking out ME/CFS patients.
What an exciting possibility the nanoneedle presented for the chronic fatigue syndrome (ME/CFS) community in the late 2010s. Not only did it suggest that a cheap and accurate diagnostic test for ME/CFS might be possible, but it was also being touted as a quick and easy way to assess treatments. We’ve heard little about the “needle” over the past couple of years, though. Was the nanoneedle a good idea gone awry?
It turns out that the nanoneedle is still alive and well. A product of Ron Davis’s Stanford Genome Technology Center, the “nanoneedle” has jumped oceans, and thanks to funding from ME Research UK and the ME Association, it’s back in action in the UK.
The nanoneedle first showed up in the scientific literature back in 2013 when a paper described it as an “ultra-sensitive, real-time” biosensor with the potential to cheaply detect biomarkers at a far more sensitive level than had ever been done before. By 2016, a redesigned and improved nanoneedle was described as a rapid, inexpensive, highly sensitive alternative to more expensive or less sensitive devices available. The authors called it “an excellent candidate for point-of-care diagnostics”.
Davis and Esfandyarpour then tweaked the needle to work on ME/CFS. Focusing on the energy deficits associated with ME/CFS, they put ME/CFS patients’ cells into an energetically stressful state by immersing them in a salt solution. As the cells expended high amounts of ATP to maintain homeostasis, they used the nanoneedle to compare ME/CFS patients’ cells with healthy controls.
In 2019, Esfandyarpour and Davis published their nanoneedle findings, “A nanoelectronics-blood-based diagnostic biomarker for myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS)“, in the prestigious Proceedings of the National Academy of Sciences (PNAS) journal.
They found that the test – which delivered 40,000 data points – wasn’t just accurate – it was astoundingly accurate – generating probability factors rarely seen in medical research (p<0.0000506). The altered electrical impedance or resistance found in the ME/CFS patients’ cells compared to the healthy controls suggested the ME/CFS patients’ cells had been put into a state of post-exertional malaise.
Klaus Wirth and company believe problems with the sodium potassium pump play a key role in ME/CFS. (Photo from Wikimedia Commons – Blausen Blausen.com staff (2014). “Medical gallery of Blausen”)
While the needle was able to differentiate people with ME/CFS from healthy controls, the biological implications of the findings were unclear; i.e. while the researchers knew something had changed in the ME/CFS patients’ cells when they were put in the salt solution compared to the healthy controls, they didn’t know what.
In 2019, the authors put forth some ideas (Na/K ATPase pump, inflammation, phospholipid synthesis, endoplasmic reticulum stress) that have only gotten more intriguing over time. Problems with the Na/K ATPase pump play a central role in the Wirth/Scheibenbogen/Lohn series of ME/CFS hypothesis papers, Maureen Hanson’s and Ian Lipkin’s labs have uncovered problems with phospholipid synthesis, and NIH researchers recently made a big splash when their findings suggesting that ER stress might play a big role in ME/CFS.
The idea that a cheap and easy-to-use diagnostic test might have been developed led then NIH chief Francis Collins to crow over the early NIH funding that helped develop the device:
“In @stanfordmed study, researchers developed new blood-based test that positively identified participants w/#MECFS. If findings can be validated in larger study, it may provide a diagnostic tool for clinicians & a target for new ME/CFS Txs. #NIH-funded https://stan.md/2IU7nYN“ Francis Collins
THE GIST
- The nanoneedle presented an exciting opportunity for the chronic fatigue syndrome (ME/CFS) community in the late 2010s. Not only did it suggest that a cheap and accurate diagnostic test for ME/CFS might be possible, but it was also being touted as a quick and easy way to assess treatments.
- In a 2019 study Ron Davis and Rahim Esfandyarpour put ME/CFS patients’ cells into an energetically stressful state by immersing them in a salt solution. As the cells expended high amounts of ATP to maintain homeostasis, they used the nanoneedle to compare ME/CFS patients’ cells with healthy controls.
- They found that the nanoneedle – which delivered 40,000 data points – wasn’t just accurate – it was astoundingly accurate in differentiating ME/CFS patients from healthy controls and generated probability factors rarely seen in medical research (p<0.0000506).
- The data suggested the ME/CFS patients’ cells had been put into a state of post-exertional malaise. It wasn’t clear, though, what was happening in the ME/CFS patient’s cells when they were stressed.
- An inability to secure funding from the NIH appears to have stopped the work from fully proceeding and no papers have been published on the needle since 2019.
- UK researchers, however, were taking note and ME Research UK and the ME Association recently announced they were co-funding a 12-month study that will attempt to expand on and validate the Davis team’s findings.
- The team has already made significant steps forward. Using “a more robust approach”, the UK researchers reported they have already replicated the 2019 results and have done so not just with ME/CFS patients and healthy controls but with multiple sclerosis patients as well. Calling the findings “highly significant”, the UK researchers stated they presented “a clear marker of pathology“.
- They will attempt to go beyond the initial findings in the new grant and identify the unusual changes occurring in ME/CFS patients’ cells when put under stress. That could give us clues as to why ME/CFS patients have trouble generating energy and functioning properly at the cellular level.
- A successful study could also, one would hope, help achieve a goal of the original nanoneedle – finding a way to quickly assess the effects of treatments on ME/CFS patients’ cells and uncover biological signatures.
- Could we have a long-sought-after biomarker in a year? Time will tell. In the meantime, congrats to ME Research UK and the ME Association for banding together to fund this most interesting effort.
The inability to get funding to improve the device, plus Esfandyarpour’s move to another University, appears to have left the nanoneedle in limbo. No studies have been produced since 2019.
UK researchers, however, were taking note and ME Research UK and the ME Association recently announced they were co-funding a 12-month study that will attempt to expand on and validate the Davis team’s findings.
Five researchers, Dr. Robert Dorey, Dr. Fatima Labeed, and Professor Michael Hughes from the University of Surrey, and Dr. Eliana Lacerda and Caroline Kingdon, from the London School of Hygiene and Tropical Medicine and the UK ME/CFS Biobank were awarded the grant.
The grant goes to a mixture of seasoned ME/CFS experts and researchers new to the field. While Lacerda co-founded the CureME team with Caroline Kingdon, and co-created the UK ME/CFS Biobank (UKMEB), Dr. Robert Dorey is a nanomaterials expert who has not participated in ME/CFS research before.
While the specifics of the grant are unclear, the brief grant description indicates the team has already made significant steps forward. Using “a more robust approach”, the UK researchers report they have already replicated the 2019 results and have done so not just with ME/CFS patients and healthy controls but with multiple sclerosis patients as well. Calling the findings “highly significant”, the UK researchers stated they presented “a clear marker of pathology“.
They will attempt to go beyond the initial findings in the new grant and identify the unusual changes occurring in ME/CFS patients’ cells when put under stress. That could give us clues as to why ME/CFS patients have trouble generating energy and functioning properly at the cellular level. A successful study could also, one would hope, help achieve a goal of the original nanoneedle – finding a way to quickly assess the effects of treatments on ME/CFS patients’ cells and uncover biological signatures.
Could we have a long-sought-after biomarker in a year? Time will tell. In the meantime, thanks to the UK researchers for pursuing this, and congrats to ME Research UK and the ME Association for banding together to fund this most interesting effort.
I found it so odd that the nanoneedle seemed to drop away from the conversation after the initial results. It was almost as if it never existed at all, or that it had been revealed to be a snake oil.
So this is great news. But there also seems to be an important lesson here. I’m not sure what it exactly is, nor if anyone is studying it or learning from it.
I don’t know exactly what happened. My understanding – which is probably not complete – is that Ron Davis failed to get funding and that when Rahim Esfandyarpour – the creator of the needle – got the opportunity for tenure at another University he was no longer able to work on it.
To me this speak to the tenuousness and roadblocks that people working in this field still encounter. The NIH was happy to fund the original research that developed the needle but even with the ME/CFS publication in that reputable journal and they excellent results, they still turned down a grant application to apply the needle to ME/CFS.
Since the UK researchers using “a more robust method” (a different instrument perhaps?) were able to replicate the results and were excited enough to take it up again, it’s pretty clear that the needle always showed great promise. It’s been up to the patient community (Open Medicine Foundation/MERUK/ME Association to keep up the effort.
hi Cort, way to ill to research. do you know witch criteria they use in the UK? IOM, ICC, CCC or what? thanks!!!
In DecodeME they must meet either the Canadian Consensus Criteria and/or IOM (Institute of Medicine)/NAM Criteria – which was developed by ME/CFS experts. 🙂
on how many patients will they try it or cells of patients please? thanks for answer!
It doesn’t say! This is what it says
“Apply the approach to a larger cohort (including mild, moderate, severe ME/CFS, and healthy and MS controls) in the hope that it will result in a reliable, repeatable, and low-cost diagnostic tool using the electrical signature from a simple blood test.”
I love the reliable, repeatable and low-cost part – it might even make it into Belgium! 🙂
thanks verry much again Cort! it is good that they take mild, moderate and severe. the severe are so often overlooked. yes what you write, the reliable, repeatable and low-cost part is good. But into Belgium? I wonder. thanks for helping me out!!!
Hi Cort, greetings from Belgium 🙂
Maybe I’m thinking way too far, but was your last sentence just a joke (Belgium being such a small country), or some meaning I missed? E.g. Brussels, the European institutions > gateway to get general recognition in Europe?
Please please please may this be successful so that people suffering everyday like me may possibly stand a chance at being taken seriously. And possibly lead to treatment.
Thankyou so much to the scientists working on this, ME/CFS patients are desperate for help.
I know a bit more than this. Rahim Esfandyarpour needed to not only get one of his grants funded to get tenure at the University of California at Irvine where he was working, he needed to get an NIH grant funded. Which is ridiculous, but that’s what he needed to do
He put all of his time and energy into the Nano Needle. And submitted a well written grant to NIH to keep working on it. When NIH turned it down, they not only ended progress on the Nano Needle, they also made it so Rahim Esfandyarpour did not get Tenure, and NIH knew this.
Ron refuses to pursue the Nano Needle without Rahim Esfandyarpour because he follows an ethical rule to never compete with his ex students. He told me today “I will never compete with my ex-students”. He is not willing to help someone understand science better, in turn helping them come up with something brilliant, and then take it away from them and take credit for it.
And Ron currently does not know what has happened to Rahim Esfandyarpour, as he is not responding to phone calls.
Rahim Esfandyarpour could be in a bad situation because of what NIH did to him and his career.
This whole story is truly horrific. And someday this will be a chapter in the long, horrific history of ME/CFS.
Dr. Rahim Esfandyarpour and your father are both geniuses. Their work on the Nanoneedle is revolutionary and I hope the world will recognize that someday. Preferably as soon as possible.
The entire last 5 years could have been so much easier if the NIH was less corrupt and less incompetent.
Measuring 1/2 of LongCovid with such high accuracy ought to be the high priority of every government health agency but clearly, the NIH serves neither Science nor patients.
This is so sad to read. As always, mecfs research getting dismissed so easily, I will never understand.
I really hope Ron can get a grasp of Rahim!
Sending hugs
So sorry to hear that! Darn the old boys club that is the NIH. If you’re not in you’re out and we are definitely still out. Hopefully that is changing. So sad to hear that Rahim has had to suffer because of that. He is not the first to get chased out of this field.
This is awful. But, I’m surprise Ron won’t push forward with something that could be so vital for us, including his son. Isn’t there any way that Ron can credit him for the work?
EXACTLY!!!! Ron should be continuing on with this or ANYTHING that could help us… heck just the testing of different medications and stuff and figuring out what could HELP US should be enough right there to have him continue on with all of this, now we have lost 5 YEARS of figuring out all that stuff and I’m willing to BET that Ron would have found one or more medications that could HELP US OR POSSIBLY CURE US!!! Ron could have credited him with all of this and I’m sure the guy would be more than happy with that because in the big picture of things the ULTIMATE GOAL IS TO BETTER THE LIFE OF THE PEOPLE SUFFERING WITH THIS DREADFUL DISEASE AND HELP US FIND A TREATMENT OR CURE!!! I’m shocked that Ron didn’t continue on to be perfectly honest!!!!!! It makes me so sad because soooooooo much time has passed and we can’t get those years back!!! I pray in Jesus name that Ron continues on with this work or the new funded group figures this out because WE NEED HELP SO BAD ITS NOT EVEN FUNNY!!!!
I was really surprised to see your name here its great to see you communicating. I was wondering whether you ever tried a type of alternative medicine called bioresonance or Rife machine therapy, its a relatively simple inexpensive technique that can in theory rule out underlying causes of a disease much faster than conventional tests. They say that it can kill viruses that normal scientists believe are untreatable even with herbs ( I also like herb medicine / nutritional approach ).
The nanoneedle is super cool I just think that as a whole conventional medicine and science in general is being held back or misdirected intentionally. Some say that most diseases are caused by toxins as a result of industrialised society rather than genetics or other factors, i’m still trying to figure out if thats true but its worth considering.
I did Bioresonance and unfortunately it didn’t help me, in fact it made me a bit worse and I felt it was very stressful on the nervous system. I’m sure it may help some people though. It is very good if you have a virus present, like Covid
The usual reason in research for things to not get pursued is negative results somewhere along the line. The OMF has been privately funding research in the past years looking for biomarkers, this research often leads nowhere. If the nanoneedle was what many patients believe it to be, the OMF could have even funded a PhD positition just for that project and involved Rahim as coauthor without having anything to do with his position and tenure. If I recall correctly there were rumours back in the day about the results not being reproducible. I hope the OMF shares their data with the team in the UK, unfortunately the OMF hasn’t been big on sharing data in the past.
Whitney’s comment below is also very concerning. Rahim is still publishing his work and receiving awards to this date.
I wonder if an additional complication might be Rahim’s status at his new University and whether they want him to work on ME/CFS stuff (???). As Whitney said, if Rahim is unable to do the work on his invention, Ron is leery of giving that work to someone else.
In any case, for right now, it appears that the needle does work.
I wonder if there’s an IP conflict with the academic institutions- That can get hairy (if that ‘s clearly spelled out above lets blame it on my brain fog)
If the invention changes the lives of millions of people, which is what you’re assuming, then that seems pretty irrelevant and it would be very negligent of the OMF to completely ignore something just because someone else worked on something first, half a decade ago.
Let’s not forget that if Rahim would have invented a new technology to detect a biomarker for a disease with previously no detectable abnormalities, then the whole university debate becomes obsolete as he can choose wherever he wants to work after that, because that’s the kind of work one would get a nobel prize for.
We can only judge if something works or doesn’t work based on actual evidence. The press release is of course positive “news”, but what counts is the actual data which hasn’t been presented yet.
I assumed the failure to get funding might have been due to the fact that the needle kind of showed a “black box” result, but at the time there was no clear established hypothesis to back up and explain the biomarker. Now as you’ve written there is more research backing up the initial speculations what causes the result.
Though “nano” and hightech in application, I guess the principle behind it of plunging cells into salt water and measuring their electrical impedance is also in a way so “low tech”, that some might not have taken it seriously enough…?
In that regard, I’ve also thought that the name “nano needle”, though cool, might possibly not have been the best name for such an assay, simply based on the circumstance that, back when I was a ME/CFS patient new to the field, with half a mind of concentration and no idea who Ron Davis is, my own first reaction to hearing about the nano needle in a forum was: “Poking cells with a needle??? What on earth should that have to do with ME/CFS? He must be a mad professor!” 😀 It made me wonder if the needle should at some point get a second name that says exactly what it does and makes it sound like an established lab assay (say, for example, CISA cellular impedance saline assay).
Anyway, I think that that the principle it is “simple” is part of what makes the nano needle genius, and with the UK project now proceeding, this shall hopefully be given the attention it deserves!
I didn’t know the needle was developed with NIH funding in the first place. That indeed seems like political considerations involved.
Here is what happened. Rahim Estyandyarpour got a position as asst prof at UC Irvine. He and Ron had every intention, and plans, for continuing the work on the nano needle, collaborating together. Rahim submitted 3 grants to NIH to fund the work to continue the development of this most promising test, but, alas, all three were rejected, for stupid reasons. Rahim is unable to get tenure at UCIrvine without an NIH grant, or a grant from another US agency. Funding from Open Medicine Foundation won’t count for his tenure. So he can’t work on it. They have tried everything they can think of to get him this grant. It makes me so so mad!
Funded the original nanoneedle hoping that it would fail. It worked. Problem created for insurance industry. NIH removes funding deep sixes nanoneedle, problem solved.
Had to go to a completely different country to get funding for proven science.
Unfortunately that sounds plausible. It seems like the insurance industry has been a roadblock to M.E. for decades.
How the heck anyone could ignore the statistical outcome of the initial research, is beyond comprehension! Perhaps they need a lesson in maths. This is very exciting. Thank goodness Open Medicine Foundation were prepared to invest initially.
Oh, I think they are very good a $$math$$.
Probably because the nano needle invention could have opened the floodgates for much more research. Which would have meant a lot of funding from the NIH, who blocked funding for decades. There was pride and money at stake.
Fauci of all people at the NIH, was very much against funding ME/CFS for most of his long time in there. (I don’t know his position on the nano needle though). But shows that influential people were against funding ME/CFS research for decades
Interestingly, ironically, or hypocritically when Long Covid arrived Fauci started saying how similar Long Covid was to ME/CFS, like he knew the disease well.
Thank you….that is good news.
It’s hard to fathom why an established, esteemed researcher like Ron Davis couldn’t get additional funding. Glad to hear that the UK has picked up where Davis left off and is looking to not only validate, but expand on the findings.
It is indeed. This is from a prior blog.
“Outside of ME/CFS Davis, has had an extraordinary run of success at the NIH. Over the past 30 years, he’s received Over the past 30 years, he’s received $2 million grants 12x’s; $5 million grants 7x’s; $7 million grants 3x’s; and $8 million NIH grants 13x’s intermixed with dozens of smaller grants. Those money totals are per year by the way.. Those money totals are per year by the way.
That’s well over $150 million in grants. It appears that for a good bit of the time, Davis was probably getting more NIH funding for his genetic and technology work than the NIH was providing for the entire ME/CFS field.”
https://www.healthrising.org/blog/2022/06/09/ron-davis-mecfs-moment-core-technology-disrupter/
That clearly changed when Ron went to work on ME/CFS.
This…is….HUGE!!!!!!! Thank you Cort 🙂
Something very unsavory or likely scandalous has happened here. The results of the initial research were unbelievably positive and Ronald W. Davis, PhD’s track record with grants and research in his entire life is impeccable. When you combine the two, it’s a no brainer for anyone honestly looking at the situation and what a real diagnostic test would do for ME/CFS. A diagnostic test is all we need to start a whole snowball of positive outcomes for ME/CFS and long covid patients. With a diagnostic test, prejudice about the illness would almost end overnight because we would have a diagnosed medical condition. No one wants to be seen making fun of or belittling a real medical condition. No one could be put in Psych Wards anywhere because they’d have a medical diagnosis. insurance companies would have to cover medical expenses for ME/CFS because it would be a diagnosed medical condition that would have to be given one of those ridiculous codes in their books. And it would keep snowballing from there.
The nano needle is such a cheap test, it would be available in Lab Corp type labs all around the world. So anyone with ME/CFS like symptoms could simply submit bloodwork and find out if they have ME/CFS in the very early days of getting symptoms, along with testing for things like vitamin levels. It would become a standard test when someone has ME/CFS-like symptoms and every doctor would test for it. And suddenly people would be getting diagnosed all over the world and the true number of affected people with ME/CFS would emerge and I promise you it would be way over the current estimates.
And it would then be impossible for NIH to keep underfunding ME/CFS with all these people having a concrete irrefutable medical diagnosis.
I’ve been saying this for years, it all starts with a diagnostic test. Everything we’ve been fighting for and dreaming of for decades will just start happening, the system will be forced to work for us.
I will have to write a blog piece on this subject as well! Thank you Cort for your wonderful work for our community
Unsavoury and/or scandalous indeed. As Sean mentions above, there is an explanation – $. I believe many people are inclined to dismiss the explanation because their (good) nature is such that they can’t relate to doing such a thing.
Insurance companies in my neck of the woods have some form when putting the $ first (heart attacks):
https://www.abc.net.au/news/2016-03-05/comminsure-denying-heart-attack-claims/7218818
It will be interesting to see where this all leads. The strategy I don’t get is that if the insurance companies know that millions of Americans will be able to get a definitive diagnosis of a debilitating disease post nanoneedle development, how does delaying the inevitable help the insurance companies? Even if you don’t get caught doing it (unlikely), how are they financially better off in the long run? The Dilbertesque side of me wonders if it is more likely that someone’s short term bonus is tied to avoiding this outcome.
Big pHARMa makes wayyyyyyy more money by NOT having a test because this is a disease diagnosed by exclusion of other diseases…. So they run EVERY SINGLE TEST KNOWN TO MAN and many times over and over because we are having to go to sometimes upwards of 50 different doctors and they all run the same tests over and over and this continues for several years!!! So think how much money they make on just doing that alone!!!!!! If there were a biomarker test then all of that gets skipped and the diagnose is and then there is no medication or cure so no treatments to make money off of.
Whitney that is spot on! This could’ve been in the works 5 years ago. Five years is a lot of time in life!
(Personal attack – part of comment deleted.)
I am happy with my self experimentation treatment.
Ok Anish. Good luck with your “self experimentation treatments”. Please be kind, think before you write something like this, and don’t post things whose sole purpose is to make you feel better about yourself. Ron and myself are real people devoted to helping ME/CFS patients like you. Thanks.
(Personal attack – comment deleted)
No personal attacks on Health Rising! Those parts of Anish’s comments have been deleted.
Ad hominem-attacks have no place in a scientific discourse. If you have issue-oriented criticism against their published papers, I am all ears.
Whitney, thank you for your intelligence, persistence, communication, information and advocacy – I hope you are feeling okay these days.
Thanks so much for fleshing out the possibilities of a diagnostic test – particularly an inexpensive one like the needle so well! Exciting stuff :).
Good to see you posting a d feisty with it!
Ron & team had continued to work and report on it so just hope the UK people spoke with him first before doing this
Yay! Thank you Dr Davis + cohorts!
Hi Cort,
Thank you for this dose of optimism! Getting a biomarker approved is the first step that opens the doors to treatments, prevention, and cures and I’m so happy to see progress finally happening.
I really wish MEAction.NET and SolveME/CFS and all the other orgs had spent the last 4 years hammering the NIH about ME/CFS biomarkers, and the Nanoneedle specifically.
There should have been a ME/CFS Biomarker Roadmap in the NIH Roadmap Series to specifically address biomarkers as a research priority.
The silence on it has been deafening, and I think that is something they will come to regret.
Do you have a link to the “grant description”? Did you mean from the press release or from another source?
“While the specifics of the grant are unclear, the brief grant description indicates the team has already made significant steps forward. Using “a more robust approach”, the UK researchers report they have already replicated the 2019 results and have done so not just with ME/CFS patients and healthy controls but with multiple sclerosis patients as well. Calling the findings “highly significant”, the UK researchers stated they presented “a clear marker of pathology“.”
Thank you. <3
HI Andrea. I, too, was very excited to see this. The links to the awards are in this paragraph. (They don’t come through in the comments.)
“UK researchers, however, were taking note and ME Research UK and the ME Association recently announced they were co-funding a 12-month study that will attempt to expand on and validate the Davis team’s findings.”
Thank you, Cort. <3
I really hope that this gets to be the go to bio marker of the future. Good point from Whitney that many many more people would be diagnosed if we had a credible biomarker (lovely to see you posting Whitney, hope you are doing ok) If a bio marker is found then people have to at last take us seriously. I hope I live to see the time when I can turn to people and say, “I told you so”.
Hej Curt thank you for you work for ME.
Absut the Nanoneedle good to know about what happen, du you know is there Any relation to the Ramon spectra analyser.? We ned so much to diagnos ME
Mvh Me patient from Denmark
🙂 The only connection to Raman I know is that it too presents a nice possibility for a biomarker, and a new study was recently funded by ME Research UK (and perhaps another UK org). The UK is the place to be for biomarkers right now 🙂
😀thank you
It is a new technique or ”test” to diagnose ME/CFS, at least according to the authors. It’s almost 100 percent accurate. This seems impossible to me in a heterogeneous population that includes ME/CFS patients. What criteria were used? It must have been a strict selection. The problem is also that this technique or test is not available at other universities in the world. So reproduction is difficult. This test will have to be validated and may be subject to a patent. In terms of outcomes, much more research is needed in other diseases, such as mitochondrial diseases, metabolic diseases, infectious diseases, etc… to determine whether these groups can all be separated from ME/CFS patients. Only experts can determine whether this test is medically meaningful. So there is still a long way to go.
The reason for the bigger study is, of course, to test it in a bigger population but I am more optimistic than you. The Stanford study was small but included a mix of ME/CFS patients – both severe and moderate and this group has apparently validated the test in a different cohort altogether.
Time will tell, of course! The test seems to me on be on track to be able to diagnose a large subset of ME/CFS patients. We shall see!
As to availability of the test – yes, it is not available but Davis produced the nanoneedle so that it would be a cheap and accurate way to diagnose disease. He was talking REALLY cheap – so implementation should not be too difficult.
The test won’t have to be assessed against everything – but it will have to be assessed against similar diseases like MS, FM, etc. That fact that it passed an early test against MS was a good sign.
I could see this moving rather rapidly. All they need is blood samples from the different groups to test them 🙂
I admire your optimism Cort 🙂 , but where is the study?
”the UK researchers report they have already replicated the 2019 results and have done so not just with ME/CFS patients and healthy controls but with multiple sclerosis patients as well. Calling the findings “highly significant”, the UK researchers stated they presented “a clear marker of pathology“.”
As I said there is no study – that’s what the group reported. For me, the fact that they went to the trouble of applying for the grant and are devoting their time and resources to this – is quite promising. Time will tell.
SARS-CoV-2 reservoirs in bone marrow. Lovely 🙁
https://www.sciencedirect.com/science/article/pii/S1567724924000072
From the Discussion: “Mitochondrial dysfunction has been extensively studied in acute SARS-CoV-2 infection…. This dysfunction is partly due to the extensive viral targeting of mitochondria and mitochondrial proteins…. Any persistent reservoir of the aforementioned SARS-CoV-2 antigenic agents could account for both the findings herein and the inflammatory state of PASC [Long Covid]…. In combination, these understandings lead to a probable second hypothesis from this work: that reservoirs of viral RNA and proteins in [the cells in the bone marrow known as human hematopoietic stem/progenitor cells (HSC)], upon HSC differentiation, remain in [peripheral blood mononuclear cells (PBMC)] and lead to altered PBMC mitochondrial function through immune activation, sustained inflammation, and the symptoms seen in PASC. Thus, the longevity of PASC would be relative to the extent of HSC viral infiltration and related to the risk factor of viremia levels. As such, this study presents a novel cellular mechanism under the currently hypothesized mechanisms of long COVID pathogenesis.”
Yikes! Didn’t Prusty have a similar hypothesis about herpes viruses in bone marrow?
Is it known whether the MS impedance profile is distinct from both ME/CFS and healthy controls, or whether the two diseases have a similar “I’m sick” profile?
Great question! I have no idea.
The original grant announcement by ME Association and ME Research UK (which Cort has linked above to the organisations’ names) says ME/CFS compared to healthy and MS controls, so I think it’s different. Adding controls with a disease (MS) with similar symptoms looks like a good study set-up to hopefully find something that is specific to ME/CFS instead of e.g. a general sickness marker or marker of pathologies shared by other systemic diseases.
For sure, and it’s a common design in ME research for that reason – I just hoped that the results were actually publicly confirmed to be unique from MS.
I read their statement as confirming that a difference in the electrical properties of blood was found also between ME/CFS and MS in their preliminary work: https://www.meresearch.org.uk/me-research-uk-and-the-me-association-announce-funding-for-a-study-that-aims-to-create-a-diagnostic-test-for-me-cfs/ “The UK researchers have already used a more robust approach to identify statistically significant differences between the electrical properties in blood from people with ME/CFS compared to healthy and multiple sclerosis (MS) controls (using samples from the UK ME/CFS Biobank).” That would be exciting!
Thanks! Great news!!
Cort, do you have the link to the paper that they claim have replicated the 2019 result?
There was no paper – just a statement that they had done so.
Another promising test and potential treatment was published in Solve M.E.
Solve Ramsay Research Grant winners (Class of 2019) and UMass Chan Medical School viral immunologists Liisa Selin, MD, PhD, and Anna Gil, PhD, recently published promising results from a Solve-funded study in Brain, Behavior & Immunity Health. The paper reported two key findings with the potential to advance diagnostics and treatments for ME/CFS and Long Covid.
First, the authors observed evidence that CD8 T-cell dysfunction can be a useful biomarker for both diagnosis and health outcome tracking for future treatments or clinical trials.
Second, the authors noticed in a small series of clinical case studies that an experimental drug, Inspiritol,a broad-spectrum immune-modulating, novel therapy, appeared to improve patients’ health and immune dysfunction. Further research with larger subject cohorts will be required to validate the predictive power of CD8 T-Cell dysfunction as a biomarker and the effectiveness of Inspiritol as a potential intervention for ME/CFS and Long Covid patients.
Curious what this test will show on someone like myself who was diagnosed with ME/CFS in 1990? Or will this just be for newly diagnosed patients? I’m much more functional these days, but I definitely still have issues.
The original study was small but it did contain a mixture of ME/CFS patients. I don’t remember that anything was said about duration….I assume it would hold true for longer-duration patients. I imagine they will be looking at that.
Along with the info from Whitney and Cort, it was my understanding at the time that part of the funding problems were due to labs being shut down or severely restricted due to COVID lockdowns. It’s great to hear this research is finally moving forward again. I do hope the credit is spread to those who started it as well as those who continue it.
Thank you to UK organisations for making this happen!
Great news that they are going to dig deeper into the pathomechanisms behind the nano needle results! As I’ve written above, I think the fact that the nano needle was a kind of “black box”-biomarker (with no proven theory what was happening in the box) might have one of the reasons preventing funding. I imagine that the absence of an established pathomechanism for ME/CFS might have made funding for a cell-impedance biomarker with no proven relation to pathomechanism difficult, too. Now UK researchers seem to tackle both, that’s great!
Next, they could identify patients both in their own study and the UK Decode ME genome project, and correlate results!
This is awful. But, I’m surprise Ron won’t push forward with something that could be so vital for us, including his son. Isn’t there any way that Ron can credit him for the work?
My guess – founded on not much – is that it may be simply impossible for Rahim to continue his work on the needle right now. It needed to be picked up by someone else and thankfully it has been.
Greetings from Greece. There are patients too here, but many undiagnosed. Me/cfs is like dark magic for doctors here. The need of a biomarker is essential for a better understanding and finally a cure.
I hope in 2024 we will have some good news!
It is interesting. If a BIO Marker is found, it could open massive gates to disability claims that are currently being denied, or not being applied for due to the hurdles in place. Cynically, this could be a reason for the denial. Without a cure or treatment plan this could be a catalyst to a financial hemorrhage from the SSDI agency. Though, I hope this thought proves to be well off the mark.
Is this connected to Ken Walder’s work?
https://www.emerge.org.au/blog/professor-ken-walder
I just read this article and it sounds so amazing! I have had fibromyalgia and CFS for 30+ years. I gave up ever finding any help but the horrible fatigue, lack of energy, brain fog and stomach issues have gotten so bad, I recently started with a sleep phycologist, a counselor who specializes in PTSD, saw a cardiologist and a new bladder cancer doctor. I am desperate to find a doctor who understands this. Do you know of anyone in Illinois? 🙏🙏🙏