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?
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.
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
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 .
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.
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
QuoteIt 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.
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!!!
Quote from: anita on June 30, 2014, 02:40:28 PM
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.
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
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.
QuoteFrankly, 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.
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.
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.
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:
QuoteNicox 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...
As far as I know the one being done in eye doctor offices are also blood sent out to IMMCO. I don't think there is any difference in the test. Someone here posted about having blood drawn at the eye doctor and sent out for this test.
I thought I read also that the eye doc one was a finger stick blood draw and that it is sent out to IMMCO for processing the sample. IMMCO processing the test is consistent. That would make sense.
I haven't seen anyone post as yet of their rheumy ordering the test besides moi. I think the eye doc version was made available this past June, but my Rheumy drew for mine end of March this year.
I went into Hopkins website and searched their news articles and I can't find any mention of the new Sjo test. I should check Duke's site also.
Plus according to the marketer's website, they have the endorsement of SJS Foundation, yet thus far I can't find anything as yet on the Foundation's site confirming that. Maybe I should sign in and search that way...hmmm
Just saw anabanana's post come through...she makes a valid point about medical academics/institutions. Now most of my docs are affiliated with a medical academic institution, except my rheumy and endo. Thus far, my medical academic affiliated docs (the rest of my "team") are accepting the IMMCO test results as valid confirmation of Sjogrens. Go figure.
Here is the test that will come out (or has already come out ) in the area of dentistry.
Really like the fact that they explain Sjogrens in more detail on their site ( Did Dry Guy post about this test?)
"Sjögren's Syndrome is a systemic chronic inflammatory disorder in which the immune system attacks and damages the body's moisture-producing glands. This causes dryness of the eyes and mouth and is associated with a number of oral and ocular complications.
In addition, Sjögren's sufferers may experience pain, stiffness and swelling in the joints, rashes on the arms and legs related to vasculitis -- an inflammation of blood vessels. The lungs, liver and kidneys may become inflamed; some people develop tingling and numbness in the limbs because of neurological complications. The disease either exists by itself as primary Sjögren's, or as secondary Sjögren's, which develops in conjunction with other connective tissue disorders such as rheumatoid arthritis (RA) or Lupus." http://www.marketwired.com/press-release/perirx-llcs-robust-product-pipeline-includes-salivary-test-sjogrens-syndrome-common-1914853.htm
Interesting how much the salivary test can pick up.
" Licensed technology from UCLA to clinically address, early disease detection and to aid in accurate diagnosis of oral, lung, breast cancer as well as Sjögren's Syndrome, diabetes type I and II and Alzheimer's disease will be commercialized by PeriRx."
Perhaps finally "Dentistry" will soon be covered as a medical necessity? Being a body part and all.. geesh.
2014 Patent to Prevent Sjogrens?
http://www.google.com/patents/WO2014036468A3?cl=en
So much on the horizon..
OK guys,
I did as I said I would and discussed the new IMMCO test with my neuro/rheumy at Hopkins...who by the way is HUGE into research as he field is strictly research and treatment of neuro complications of Sjogren's (and other rheumatic diseases).
Please don't shoot the messenger...LOL
As soon as I mentioned the test, he jumped in an interrupted me saying, don't waste your money. I asked him to elaborate about the test, accuracy, etc. He said (very adamantly) that the test is NOT validated and therefore not considered accurate or credible. After he realized I wasn't asking for me to take the test....and I did explain I was inquiring for many here who would also like an expert opinion on the matter. Then he opened up into a more detailed conversation.
He said that NO specific studies had been done on this test and that the ONLY credible antibody markers are the SSA & SSB...not the "novel" markers this test claims to detect. Then he added that Johns Hopkins (and HE would be directly involved as well), is "considering" (and he used this word very carefully, and repeated it) validating the test. He said JH is being requested to review the data and run the necessary studies to deem it credible and accurate. At this point, JH (and Dr. Birnbaum himself) have NOT decided if they will participate with the validation process...but he repeated that he IS considering it (at least looking at their data). NO other major institution has validated the test according to him (as why you don't see it mentioned at other places, I guess), so JH would be the first.
I personally would like to see him and JH take on this task (and stated that to him) and give it the attention it deserves...as it may be a valid/accurate test that will help many get treatment that don't receive it due to testing negative on other labs (SSA & SSB).
So there you have it...one professional opinion.
Thanks, Anita!!
It's good to know that JH is considering at least looking at the data. I see my rheumy Thursday so will ask him about that. Maybe the initial targeted marketing of the test is for purposes of data collection to lay the foundation for JH and others to validate. I mean they have to have data to validate the viability and accuracy of the test.
We'll see what my rheumy says on the subject. I don't mind being a lab rat for a test, at least it's not in the blind treatment without fully informed consent. ;) But still, if that is the why behind why he ordered that test, I'd sure like to know if the results are considered valid or are they laying a foundation to get it validated
Amanda
Baylor now offers this test as well. I'm finally getting to take it next Monday! Whohoo!
Quiet, I have posted about these tests. I spoke with my Rheum who is a sjogrens guru about it a few weeks ago. All the sjogrens gurus(Carsons, Vivino, Fox etc) had a conference with NICOX/IMMCO regarding the sjo test in May. They want access to it to study it and are fighting with NICOX who just wants optho to have it(NICOX is an optho company). But he also told me that opthos are using it and he's had multiple referrals from them for people who went to the eye doc with dry eye and tested positive.
I'm negative on everything but being treated as sjogrens and he asked me once I get a new optho if I could take the test and send him the results. I just moved down south so once I go to an optho here in a few months ill request it and send him the results. Because he considers me as having SjS but in the category of negative for everything.
He's also fighting for rheums to have access to it as well. He also told then they should license it to a company like quest so more people have access. NICOX is being "obnoxious" tho about it.
QuoteHe's also fighting for rheums to have access to it as well.
There's another question for my rheumy - he not only was aware of it but ordered it with no problem from IMMCO this past late
March.
So there is ONE rheumy anyway who orders the test- mine. I am even more intrigued about it as apparently it IS being marketed to Optho's.
Hmmm
Didn't the Optho version just get rolled out in June? So my test was done a couple of months before it was rolled out to Optho's, yet ordered by rheumy. Hmmm
Hey guys,
Okay, my rheumy visit today and please don't shoot the messenger...
...bottom line it is a money issue as to why places like Mayo and JH are not as yet using this test.
Also, FYI, there can ALSO be false negatives with the IMMCO test. My understanding is lower false negative ratio on this test than the standard tests for SJS.
I asked rheumy about these false negatives, as I actually experienced SIMILAR when my thryoid was hashi's under the radar. I was actually termed subclinical by two endos and two ents on that issue late 2008.
In his opinion (he's been in practice nearly 30 years), there is a component to these AI's in some of us that is termed subclinical. In other words, having the disease and respective manifestations yet negative on the standard lab work. That is his explanation as to why symptoms need to be treated as opposed to waiting for an eventual positive result...the subclinical component of AI's in some patients.
Also, the value of the IMMCO in his opinion is that it confirms for teh patient that yes this is what it is: SJS. Thus far, every one of my specialists to include PCP have accepted the IMMCO test results (positive findings) as definitive and valid confirmation of SJS. My other docs other than endo are affiliated with Wake Forest Baptist University Medical Center (ranked 12th in several specialities nationwide and very involved in research studies).
Amanda
There is false negative (and positive for that matter) that can occur with ANY test, as far as I can tell. I have yet to see one that you cannot find that statement somewhere in the literature.
I have no idea how money for JH & Mayo is playing a role. Please give me an example. It's not like the ordering physician is getting a kick back to order the test, right? Are you indicating that your doctor gets money from ordering it and JH isn't so they won't use it? It's not like my doctor would financially benefit from using or not using the test...I don't understand. Unless these opthos (and select rheumys) are getting kick backs to use it as part of marketing it to them...that's just plain wrong.
There are "clinical" diagnosis all the time. Many conditions have 'criteria' (like Sjogren's), but there are always doctors that will treat based upon symptoms...especially when known blood work is not full proof...which my JH doctor says up to 40% with Sjogren's are sero-negative.
There are 'some' that won't treat unless they fall into right group with + labs. There are also things like social security that uses criteria to confirm diagnosis to approve disability....this is when new tests like this come into play. it takes a while to be 'accepted'.
I only repeated what I was told and read nothing into it what he said. In context, in effect he said some of the larger institutions at this point don't want to expend the money to be able to handle this test directly. His onsite lab IS set up to accommodate this test.
I did not read anything as alluded to in his statements at all, Anita. May I suggest that no one imply anything nefarious in his statements. He did not even allude to anything nefarious AT ALL.
Respectfully,
Amanda
I didn't not mean to imply anything nefarious...and hope I didn't.
I just don't see how any money is necessary or involved in this test...and I was looking for possible scenarios that could explain his conclusion. Doctors/institutions don't 'pay' for tests to be run or handled. I'm not sure what he meant...I was simply hoping you might have a guess as to what type of money reference he was making...that's why I asked for an example. It would have been nice if he elaborated on his pointed statement.
Can you think of a possible scenario where money would come into play? That's what I was looking for...as you have been around this system almost as long as I have so thought you might have an idea that I could not think of.
So is his 'onsite' lab running the test? I thought you said he sent it out to IMMCO...as all the others do. All labs send out samples to other facilities/labs as there are SO many labs that have to be processed at specific facilities nowadays...no one labs does them all. if your doctor is processing/running the lab onsite, that is different and would explain the 'cost' factor for equipment to process its. But patients/insurance are the ones who pays for lab work, not doctors. And sending labs off to specific facilities is worked into the cost of the lab.
Again, I don't want anyone to think I was implying anything bad. Maybe I should have worded different but was just bouncing ideas around as to how money can play a role in a test that doctors don't pay for (patients do). Gosh, knows there have been many times doctors take kick backs for things and I know there are places online to search your doctors for dinners, gifts, and other "benefits" that they get from drug manufacturers. Money is what makes the world go around...and medicine is BIG business just as BIG pharma is also. And if money was to be made from this test...JH & Mayo would be right there to collect...LOL They are just as greedy as the rest...LOL
Keep in mind I was there for followup and had related questions pertinent to that. I am given to understand that this test is available to all rheumatologists and that there was an expenditure on his part to be able to offer the test. I don't gather that it was significant.
In the context of that portion of conversation, he gave as an example of how anal some of these affiliates are becoming. His example, was one of his bills re: one of his affiliates was paid 10 cents short. TEN CENTS!!!. Actually it was likely an encoding error on the part of the bank that initially processed the check. Happens more than people realize.
There was a time that such a nominal amount was written off. It's not cost effective to collect 10 flippen cents. Consider the postage, consider the billing, consider the time invested (I would imagine at that level of accounting probably an hourly wage of $15 an hour), print the bill, stuffing in envelope etc.
Costs well over ten cents by the time all of that is done, just to collect ten cents??? oh factor in post office, and delivering the ten cent bill. He or his staff opening the bill and the time expended to pay a ten cent bill and postage or whatever time is invested to pay it online. Time has value too, so that is also factored into cost analysis.
Now he was non-specific in his example as to which medical facility did that but he was not happy about it. In my view he made his point and I was satisfied with his answer. I wasn't there to interrogate him. I committed to asking him about why some of the bigger medical facilities such as JH and Mayo are reportedly not offering it. That is the sum total of the answer he gave.
Yes, he did send out the tube of blood to IMMCO. At least the report came from them. But as I said, I asked the question and that was the answer I was given.
Also, I am given to understand that this test is not a matter of course to run. It is an option where if seronegative and additional validation of diagnosis beyond the clinical presentation.
My rheumy didn't even mention this test until I asked him last March if they ever retest the standard tests for Sjogrens. He offered the IMMCO one.
Anita & Amanda,
I just read this thread. I was looking for information to share with the members of my support group at our next Feb.7th meeting.
This is really interesting stuff. Before I read all of your comments, I sent a message to my doc to see if he is using it? If so, what does he think? If not, why not? I then sent an email to SBH Diagnostics to ask about heir EASy-Sjogren's test to see if it has gone to market? If so, how are physicians receiving it? If not, when is it expected to hit the market?
I know my doc will answer..but will wait to see if SBH answers.
SjoDry
One more thing.
I know in former comments, it was not clear whether the Immco test was just one blood test or there are two?
On the Immco site: http://immco.com/sjogrens-syndrome/default.aspx you can pull up/print out their Sjogren's brochure for the eye test.
It says (and shows a diagram) of the In-office test. It appears that a finger is pricked, the samples put on a card & then sent out to Immco for the results.
SjoDry
I'm interested to hear what you Rheumy has to say about this test, SjoDry. When I mentioned it to my Rheumy, she completely "pooh-poohed" the test for whatever reason.
Maria
My DIL is an optometrist and she is in charge to the Immco info that they are starting to gather in regards to the testing and results, etc. I saw the list of blood work that is done and it is a long list of tests. Some of them I have never heard of. I asked about the cost and she thought it ran people around 250$ after insurance paid.
We live in MN so maybe there is different criteria in our state regarding insurance coverage. Sounds like they think this test is of value. I will hear more after they have done it longer I would think. Irish