Project Lyme Video - New FDA approved Lyme Test - Claims 100% sensitivity!

if this works out as advertised - its a game changer!

it looks like Igenex has been working for some time with the FDA to gain approval for a new blood test for Lyme disease.

the headline is it is apparently 100% sensitive and 100% specific ( or as close as makes little difference )
( this comperes to around 50% sensitive and 50-80% specific for existing main lab tests - like C6 Elisa and Western blot - which has been a basis for lyme denial and misdiagnosis for decades)

they have achieved this using 30 different specially selected recombinant borrelia proteins as antigens - taken from over a dozen species of borrelia that cause lyme disease - and its these recombinant proteins (rather than lysed whole borrelia that most tests use) that they say are responsible for the remarkable sensitivity

Dr Burrascano ( of the original lyme treatment and diagnosis guidelines fame ) gives and excellent presentation explaining
- the history of testing
- the problems with it
- and why this test works so much better.

the only proviso i would add is that Dr Burrascano works for or consults for Igenex.

that said i think the FDA would be expected to be conservative - if not resistant to new better tests - so i would expect them to have been pretty demanding before approving an alternate test, so i would guess it checks out pretty well.

in the presentation he shared some data on how many sero-negative patients ( ie negative on western blots ) were actually positive via this new method ( almost all of them ) - usually involving an alternate species than the supposed main USA species, Borrelia Burgdorferi - including Borrelia Californiensis, Borrelia Mayonii and also the supposed "European Strains" - B. Alfzelii and B. Garinii

this is big news - because, with a FDA approved test that actually detects effectively all lyme disease cases, including Chronic Lyme - there will now be a "black and white" test available - so the Lyme deniers and ignorant doctors will have a much harder time misdiagnosing or refusing treatment - and there will finally be pressure on Insurance companies to cover treatment.

Regarding Insurance coverage - as i understand it is their own commercial decision as to what tests and treatments they cover - but if a patient tests positive with an FDA approved test - its hard to see a strong argument for refusing coverage - although i imagine it will take time for them to adapt.

i thought the presentation was very well done - well worth a watch

link to video here - its around 40 mins long and aimed at the lay-person/patient - rather than in depth technical
https://www.youtube.com/watch?v=p7ak7jmxxgo

actually Burrascano eluded to that as one application in the closing pages of his preso - but i didn't get the details

perhaps they have data to show what happens to chronic lyme cases in terms of antibody response to all those antigens changing over time -

to this point we have studies that show some people have antibodies for life after lyme disease -

but because we don't have good ways to really know if they have truly eradicated the organism - or if in fact its still there but held in check by the immune system (as is normal for many other common infections - eg chicken pox virus etc)

its possible with such wide differentiation between true positives and true negatives of this test - they can see a shift from active infection - to "cleared infection" - or "infection under control" in the bands

astroman said...
All I can say is wow.

And it would work on a chronic lyme? Double wow.

A lot of people like me who aren’t quite sure if it’s all gone or not, would definitely like something like this!!

yep - those are my sentiments also

have a look at the presentation - it seems like they tested it on chronic lyme patients - including those that were sero-negative via conventional western blots

the whole reason most of us are still ill is that diagnosis was so poor
either
the doctors didn't believe in lyme - or that it was relatively common - and didn't even test for it - so we didn't get tested or any treatment at the most effective time.
or
we were tested and the test was negative so we weren't treated
or
we had a bulls eye rash - or were tested positive - but the doctors didn't believe more than a few weeks of antibiotics were needed - so after that were told we couldn't have lyme - and no more treatment was offered

all of these outcomes lead to chronic lyme and medical denial and therefore unsupported patients.
and insurance companies are able to duck out of covering it - as there was no definitive test.

having a test that can 100% ( or as close as makes no difference ) prove lyme disease - has the potential to change all of that - such a test has been the biggest single thing we have been missing for decades

once the true scale of the disease is known and accepted - the costs of medical care associated with it go from a hot potato no one wants to hold - to a business opportunity, like any other disease - and the other major missing piece of the puzzle - effective treatments - will be addressed.

i would like to read the validation studies - but from what i have seen so far it looks encouraging.

Rampage said...
Sounds interesting but something to keep in mind is that “FDA approved “ doesn’t mean what you think it means. We sell laser caps where I work to regrow hair that have the same label. I’ve never seen it work.

This test, indeed would be a game changer but I’ll keep grounded until it happens. Fingers crossed!

i share some of your scepticism - and am also a little wary until we can see data on chronic cases etc - but the key point is that a test with the rubber stamp of approval from the FDA means that patients can ask for it - and doctors and insurers will have a hard time denying the result.

ultimately i think we would need 3rd party verification of the test performance to know for sure exactly how good it is - but based on the antigens used and the data shared so far - it looks like the majority of the false negatives in current western blots are due to patients being infected with species other than the Sensu Strictu B. Burgdorferi B31 on which those tests are based. so it looks like it will be a significant step forward merely by including antigens from all the other common species.
tests based on recombinant antigens are also known to be cleaner and more specific so it has this in its favour also.

Garzie said...

Rampage said...
Sounds interesting but something to keep in mind is that “FDA approved “ doesn’t mean what you think it means. We sell laser caps where I work to regrow hair that have the same label. I’ve never seen it work.

This test, indeed would be a game changer but I’ll keep grounded until it happens. Fingers crossed!

i share some of your scepticism - and am also a little wary until we can see data on chronic cases etc - but the key point is that a test with the rubber stamp of approval from the FDA means that patients can ask for it - and doctors and insurers will have a hard time denying the result.

ultimately i think we would need 3rd party verification of the test performance to know for sure exactly how good it is - but based on the antigens used and the data shared so far - it looks like the majority of the false negatives in current western blots are due to patients being infected with species other than the Sensu Strictu B. Burgdorferi B31 on which those tests are based. so it looks like it will be a significant step forward merely by including antigens from all the other common species.
tests based on recombinant antigens are also known to be cleaner and more specific so it has this in its favour also.

I’m hopeful because it would change the game and help so many people that struggling with insurance and such.

I’m not skeptical of the idea of the technology being possible but they are throwing red flags by putting weight on the “fda approved” term. I’m skeptical of how they are selling it. The same way I’m skeptical of supplement companies that use terms like “proprietary blends” and of drs that quote their own studies. It’s my background though. That type of stuff jumps out at me. Maybe I’m jaded.

This could just be a case of an aggressive marketing dept but they actually have a good widget. I’m hoping that is the case. Thanks for posting this, btw

Hi Garzie,
an interesting information. Does it have a sense for someone chronically sick with lyme and bart with persistent infection, like myself, to try say Lyme+Bart IgG immunoblot from them? Not sure whether it is more important for newly infected ones...
Best wishes,B

i have been doing a little digging into the figures given - as the key thing for me is how well the test actually performs

i have been looking for the validation study's that this 100% sensitivity and 100% specificity have been taken from - so far i haven't been able to find them.

so i have dropped an email to Project Lyme to ask them.
given they are a patient advocate and education organisation - they really ought to be wary of promoting products or platforming people who do - without the data to back up the claims.

will update if i get anything back

Not necessarily

With these non-standard infections IgM can be present in the later stages

Especially for borrelia.

But i think the igenex test we are talking about is focussed on IgG in disseminated disease in any case.

small update

Project Lyme replied to my questions on their youtube channel with a reply that seems to appreciate the points raised - they say they are contacting Dr Burrascano for his comment.

see questions and response below

will update here if we get a response from Dr B
=================

@bendangerfield181
8 days ago
I notice Dr Burrascano is listed as a consultant for Igenex on their website and that he has appeared in multiple videos promoting their products - but in the presentation he states he does not work for Igenex. This is a source of confusion and a potential conflict of interest. given Project Lyme's mission statement is to educate, rather than promote commercial products - I hope you will agree your viewers should expect full transparency so we can properly asses the material presented. With this in mind, can you clarify the presenter’s relationship with the test manufacturer.

Also – Dr Burascano describes the test as 100% sensitive and 100% specific – this would indeed be a huge step forward in testing - and a potential game changer for addressing the way Lyme disease is managed. However, there were no references given for how this figure was obtained, as far as I was able to see. Now its well-recognised that strong claims require strong evidence – so can we see the validation study that supports this figure please?

As I am sure you have noticed - the tone of many of the responses in these comments is wary or even negative. I think we can all appreciate that the chronic Lyme patient community had been gaslight, lied to and generally let down by doctors, institutions and, as highlighted in this presentation, by testing in general.

Surely this means, that, as a patient advocacy group with a mission to educate and support patients, Project Lyme has to go the extra mile to provide full transparency, and data to support the claims made by the representatives of commercial entities it gives a platform to. Otherwise, how are viewers to differentiate its materials from commercial product advertising?



Reply

Highlighted reply

@projectlyme8087
1 hour ago
Hello. Thank you for reaching out and raising these important questions. We have reached out to Dr. Burrascano for clarification and will update that information as soon as we have it. Have a great day!



Reply


@bendangerfield181
1 second ago
@projectlyme8087 Great to hear - thank you very much - look forward to hearing back.

Bailey I have not read it but the way I understand it is that the numbers were pulled from the study below. Table 5.

The IGeneX flyer has always claimed >97% from memory, for this new test. I haven't watched the video, so I don't know what was said by Burrascano.

For what it's worth IGeneX has always done right by me. It's how I was diagnosed.

https://www.mdpi.com/2227-9032/6/3/99

My doctor had me take another round of Lyme, Bart and Babesia tests in October since it had been a year since last tests. All three were positive again (Borrelia, Immunoblot IgM positive - Batronella, Immunoblot, IgM positve - Babesia FISH IgM positive.

Where I'm leading to is I called Igenex and spoke with someone there to question the validity of the tests for Borrelia and Bartonella.. She said the tests' sensitivity were 99%. I had never read that before, but had read the Immunoblot is around 94-95% sensitive and specificity is about the same. Not sure about the FISH test for Babesia. Now I'm wondering is she was thinking about the new test that is mentioned here,

What she said threw me, and after reading all the posts here, I'm wondering if she was confusing that with the new test that is being touted by Igenex. Thanks for posting, Garzie.

RainyCloud said...
Bailey I have not read it but the way I understand it is that the numbers were pulled from the study below. Table 5.

The IGeneX flyer has always claimed >97% from memory, for this new test. I haven't watched the video, so I don't know what was said by Burrascano.

For what it's worth IGeneX has always done right by me. It's how I was diagnosed.

https://www.mdpi.com/2227-9032/6/3/99

hi Rainy

this exactly the issue
- Burrascano says 100% sensitive / 100% specific

- Igenex website says 93% sensitive - here https://igenex.com/igenex-immunoblot-test/

- i have not been able to find anything online that supports 100% sensitive and 100% specific

- maybe like you say they have published other figures at other times - like your 97% figure

this may not seem like a big difference to some - but its actually worlds apart -

if its 100% sensitive and specific then the test is essentially guaranteed black and white - and a complete game changer -
if its 93% sensitive - then close to 1 in 10 people will get a false negative - and some will get false positives - but no one will know who gets the bum result - so the value to any given individual is dramatically undermined

i have read the pilot study you mention - which seems to be standing in for a proper validation study - so far i can see a number of issues with it

one of the main ones is just a simple numerical issue due to the small sample size involved - presumably why they are calling it a pilot study - but the issue with this is you cannot actually prove 100% sensitivity with such small sample sizes as the study is not sufficiently powered to do so -

as a result, as listed in table 5 - the study can only really show with 95% confidence that the sensitivity value is somewhere in the range 84% to 100%
to claim this is in fact a solid 100% as Burrascano has done in the project lyme presentation - is disingenuous and misleading unless there are more studies available we do not yet have sight of ( the 84% figure is just as true as the 100% figure )

there are also methodological issues - for example - the positive control samples that were used as the true positive samples in the above calculation came from the CDC - and it looks like these were deemed positive via CDC's own serological tests - eg western blot - this approach would exclude samples that were from infected patients but were sero negative - and represents a circular logic in the study design ( the new serologic test has more favourable chances of detecting samples already found positive by other serologic tests using many of the same bands). samples proven positive by culture or PCR, as has been done in other studies, would provide a much better sample - for true positive controls.

finally, for most people coming here and those already here - the key questions are around how good is this test for chronic cases - and here we have very little information to go on

Hey Garzie - The doctor that ordered the tests were my primary care doctor, who is more familiar with the "Lyme world" than most any other primary care. When I saw the LLMD I see about 5 months or so ago, he seemed to think I was still staying IgM positive, based on the tests from 6-7 months before that. I have consistently been positive each year on the tests.

I do trust both of them, and the reason she did this last test was to make sure there is still consistency in the test results because she is concerned about treating something not there and aggravating the Sjogrens.

As far as costs, I have none as Medicare covers Igenex testing. Each year I pay a $260 deductible, and everything else is covered after that. Without the additional Plan G coverage with Medicare, I couldn't possibly afford the IVIG infusions, which make Igenex testing costs like peeing in the ocean.

I meet with her next week about what to do with the positive tests. The hope is, as you and I have discussed, treating Lyme might help Sjogrens symptoms without aggravating them.