Anyone know the latest blood test for Sjogrens?

[anita]

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.

[litliwlowa]

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.

[quietdynamics]

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..

[anita]

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.

[litliwlowa]

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

[Tharrell]

Baylor now offers this test as well. I'm finally getting to take it next Monday! Whohoo!

[DryGuy]

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.

[litliwlowa]

He'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

[litliwlowa]

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

[anita]

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'.

[litliwlowa]

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

[anita]

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

[litliwlowa]

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.

[SjoDry]

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

[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