Anyone know the latest blood test for Sjogrens?

[dmarie71]

I recently read information about a new blood marker that has been linked to Sjogrens.  I remember reading that most sero-negative Sjogrens patients will test positive for this.  I am headed to the rheumatologist later today and want to ask her about it but now I can't find the information. Can anyone help?

[litliwlowa]

The one my rheumy ordered on me was teh labdraw IMMCO test, not to be confused with the newer one coming out to eye docs for testing. He drew blood in his lab and send it on to IMMCO for processing Mar 2014

I tested positive for the novel SS antibodies.

Last year I was tested on ANA, RO-LA, SSA and SSB and was negative Mar 2013. Rheumy has not repeated those tests.

[anita]

I think the IMMCO test for 'novel' markers is the same one being used now in eye doctor offices (and sent to IMMCO).  According to IMMCO's website, there is no indication there is two different tests.

I'd have to see more studies and comments by rheumy's about it's accuracy first.  I wonder what the % of accuracy is...or how they even check that.  If it was a great accurate test, why is not being used by Mayo, Hopkins, Cleveland Clinic, etc?

http://www.immco.com/sjogrens-syndrome/default.aspx

[Tracyrose]

Be careful about this regarding insurance . I called numerous times and eventually found out it would not be covered ( only the actual blood draw) and it was almost 600 hundred dollars. Guess I am not having that !! You can download the forms from the immco site . 

[litliwlowa]

I had to sign the form in rheumy's office that I understood the test might not be covered by insurance. I haven't been billed yet and my test was end of March this year. It took a good couple of weeks for the results to come back. I haven't gotten a Medicare statement as yet to know if it's been filed with them. Nothing yet on supplement insurance.

As to the question of the reliability of the results as previously mentioned, my rheumy accepts the results as valid, as do my other specialists. I'll defer to their judgment on that one. Typically I run subclinical anyway on certain lab tests. Sux but oh well.

Plus the positive eye test last year and the clinical presentation of persistent and severe SJS symptoms. Thankfully my rheumy started treating me at first consult last year.

[anita]

Amanda,

I'm glad your rheumy considers it valid...and that's really all that matters.  He may have more info on it.  I'd just wish that put out for all to see the actual studies (both sides), not just the studies they 'want' us to see, which is how it usually goes.

Doctors at reputable institutions (Mayo, Hopkins, CC, etc) commonly use off-label & non-FDA approved medications, so it's not a matter of Gov't approval that keeps them from endorsing the test.  I'd be interested in hearing why they don't...just because I like the background on products & testing.  Insurance is always last to come around so I don't even consider them in whether a test is valid or not.  I hope you don't think I dispute the test...I don't have enough information for that either.  It'm my point....There is not enough info out there either way...and there should be so people can make informed decisions.

It all comes down to getting treatment.  So if standing on our heads gets them to take us seriously, then that's what we need to do...LOL

[litliwlowa]

It all comes down to getting treatment.  So if standing on our heads gets them to take us seriously, then that's what we need to do...LOL

isn't that the TRUTH? Geesh!!!!

I wonder if any of our members go to Hopkins or Mayo and can ask their respective rheumy what their position is on the IMMCO test.

Basically anything I find on it says it's proprietary to IMMCO and connected with UB (University at Buffalo).

Oh wait, I found this dated Aug 2013: http://blog.bostonsight.org/index.php/2013/08/blood-test-for-early-detection-of-sjogrens-syndrome-now-available

Now here is a thought. A marketing company is working to promote the IMMCO test nationwide. Now I don't know about Hopkins, etc, but I know my doctors affiliated with Wake Forest Baptist do NOT permit at least pharma reps (WFB is also very involved in research and is a teaching affiliated hospital) on site...

...however, my rheumy is not affiliated with WFB rather the other medical center in this area and they DO permit marketers on site.

I wonder if that possibly is why Mayo etc isn't using it as yet?

Dern, my curiosity is up now. Soon as this flare passes ( I sure hope SOON) I wonder if calling Hopkins etc to simply ask them directly would answer that question.

[anita]

I see my neuro/rheumy at Hopkins next Tuesday.  I'll make a note to try and remember to ask him.  I'm interested in what he has to say as well.

I HATE this proprietary crap and it certainly has something to do with it...the almighty dollar!!!

[litliwlowa]

I see my neuro/rheumy at Hopkins next Tuesday.  I'll make a note to try and remember to ask him.  I'm interested in what he has to say as well.

I HATE this proprietary crap and it certainly has something to do with it...the almighty dollar!!!

Thanks Anita.

Oh don't get me started on the dollar RANT!! 

I was thinking after reading the Aug 2013 article, it appears that it was the first rollout to the "market". I didn't even know about it until I asked my rheumy if he ever retested for SJS and the IMMCO test is what he ordered.

I wonder if Hopkins and Mayo and some of the others are holding off on staking their reputation on it just yet. Just a thought.

[quietdynamics]

Most Dr. and Medical Institutions follow the accepted "Criteria".
It is not a matter of them validated or invalidated a test.

Diagnosis Criteria
Research Programs
American-European Consensus Sjögren's Classification Criteria
The classification criteria for Sjögren's syndrome (SS) currently used by clinicians and researchers around the world is the American-European Consensus Classification Criteria. Because many different criteria previously were used both within the U.S. and in other countries, the Sjögren's Syndrome Foundation and members of the European Study Group on Classification Criteria brought international leaders in Sjögren's together to develop consensus on one set of guidelines.

2014
Comparison of the American-European Consensus Group Sjogren's syndrome classification criteria to newly proposed American College of Rheumatology criteria in a large, carefully characterised sicca cohort.
Conclusion:The two sets of classification criteria yield concordant results in the majority of cases and gene expression profiling suggests that patients meeting either set of criteria are more similar to other SS participants than to healthy controls. Thus, there is no clear evidence for increased value of the new ACR criteria over the old AECG criteria from the clinical or biological perspective. It is our contention, supported by this report, that improvements in diagnostic acumen will require a more fundamental understanding of the pathogenic mechanisms than is at present available. http://www.ncbi.nlm.nih.gov/pubmed/23968620

[anita]

QD,

I agree!!

However, at some point the lab tests for SSA & SSB became part of the current criteria and accepted in the field as an appropriate and accurate test for marked antibody presence.  The process was probably extensive.

I believe these large institutions have a considerable say and carry much weight when it comes whether a new test is accepted into this criteria.  Actually it comes from MANY sources, not just these facilities.  I just used them as an example because the are recognized in the industry/field for excellence in this area.

So my conclusion (and opinion) is that if these large names don't endorse the test, then there's a reason...and I wanted to know what that is.  They are always looking for new and improved ways to diagnose conditions.  If something has promise you always hear the big names reporting on it and I hear NOTHING from them on IMMCO.  Frankly, the only things you hear comes ONLY from IMMCO and it's marketing...that should be a reg flag.  So it can't hurt to ask someone that is a major player in research for diagnostics Sjogren's and neuro complications.  My neuro/rheumy has done much research in this area and I have even participated in new research for diagnostic labs for Sjogren's.  I had donated blood at every visit for several years toward this cause.  So I think he might have a valid opinion on the subject.  It can't hurt to ask.

But as I said, it about getting treatment and if this test achieves that, then it is a success in some regards.  But it may not be enough... as insurance must pay (for the test itself or subsequent medications needed to treat) or for disability (LTD/ STD/SSDI) to recognize and accept.  There is so much more at stake then just a positive or negative result.    But I do believe it's a start in the right direction.

[litliwlowa]

Frankly, the only things you hear comes ONLY from IMMCO and it's marketing...that should be a reg flag.

I wonder if it is a money issue and here is why. I see what is charged on labwork on my Medicare statements etc. To be blunt, IMHO, the early SJS test is grossly overpriced. But then at present it is also proprietary, so in effect IMMCO can set whatever pricing they choose.

I'll be most interested in what your Hopkins Rheumy has to say. I'm still waiting to be billed. I don't know if I'll be billed directly by IMMCO or via my Rheumy. I know Medicare can be slow, but 4 months slow? Not usually.

Then the question enters my mind, if the billing comes through the doc office ordering it, especially given the cost of the test, that adds more burden on the doc office for billing and collection thereof. Makes no sense, especially as IMMCO accepts no insurance near as I can tell.

So I'll be most interested in what your Hopkins Rheumy has to say on this.

[quietdynamics]

American College of Rheumatology Classi?cation
Criteria for Sjo¨ gren's Syndrome: A Data-Driven,
Expert Consensus Approach in the Sjo¨gren's
International Collaborative Clinical Alliance Cohort

p.478 left column gives eligibility for SICCA registry for 'their' research.
+ANA plus .. +RF.. and or SSA/SSB.. etc.
file:///C:/Users/barbara/Downloads/2012%20ACR%20Sjogrens%20Classification%20Criteria-FINAL.pdf

* So in this case the 'criteria' is different. +ANA and + RF will have one eligible for research.

Do not think general Rheums are using the above yet, (muddies the waters?).
The IMMCO test is new .. so many have not even heard of it (churned waters)
.. I saw another patent has been approved test this spring 2014 (think it was for dentists?..could have been ophthalmologist.)

These are based on the all the preceding research and the newer genome tech.
So changes.

I do not believe it has anything to do with money.
Simply the fact that better science is available now.
Science progresses, it is not stagnant.

Read an article, just last year another layer to the cornea was discovered.
Something  considered a done deal.
Why? Better tools, tech.

The IMMCO test can be done for novel apects alone in which case the cost is about $300 or so. Dr. can order the ANA, SSA/SSB and RF, ..if already done, no need for redundancy.

[anita]

I think you may have misinterpreted the money reference.  Science has advanced and so has the cost of that advancement. You are absolutely correct in that regard and hopefully we did not imply otherwise.  That's not the reference we were making...it was about the propriety nature being infused into medical advances that gives them means to drive costs up...and that they DO without a doubt.  Medicine is a business first, help for patients, second.

But this shouldn't be the focus of this thread and maybe I should have left my comment out.  This is about what's available out there and whether it's helpful to people looking for a diagnosis and subsequent treatment.  I will get my rheumy's input next week and post it here.  I hope others see this thread and maybe have already discussed with their doctors and got input.  I don't know if this test is widely known yet.  But it's a good thread and both sides of things like this should be looked at when new treatments, medications, or testing comes out.

[litliwlowa]

Anita

Actually I think your comment was valid. I see my rheumy on the 10th and am going to ask him that very question. See what he has to offer up as an answer.

Until we go to the respective sources that would KNOW, IMHO, anything else is hypothetical at best.

I did find another article:

Nicox launches Sjo(TM) in the US and partners with the Sjogren's Syndrome Foundation

http://callcenterinfo.tmcnet.com/news/2013/11/12/7534136.htm

But this article appears to be marketing to Eye docs. Hmmm, I don't see my eye doc until October.

This article also from: http://www.oteurope.com/ophthalmologytimeseurope/Dry+Eye/Nicox-and-Immco-to-develop-Sjoumlgrens-syndrome-di/ArticleStandard/Article/detail/816271

Actually, there's been a couple of other threads running on this topic recent weeks (I think one maybe started by DryGuy) and it was all about the version for eyedocs. Yet it was my rheumy that did lab draw (full testube) that was sent out.  Very strange indeed.

I wonder if anyone else has had this test in rheumy office...