Reading about this development, the consistent opinion is that Ro and La occur later in the disease process, although symptoms may present. I would have liked to read the comment by Dr. Fox, but sadly I cannot find it.
Sjogren's Syndrome: New Discovery by UB and Immco Makes Early Diagnosis A Reality for the First Time
The new diagnostic test will be available to physicians in early 2013
By Ellen Goldbaum
Release Date: December 12, 2012 http://www.buffalo.edu/news/releases/2012/12/13854.html
"BUFFALO, N.Y. -- Patients suffering from the painful autoimmune disease, Sjogren's Syndrome, will soon be able to be properly diagnosed much earlier, thanks to the discovery of novel antibodies by researchers at the University at Buffalo and Immco Diagnostics, Inc. The breakthrough, described in a paper in the December issue of Clinical Immunology http://bit.ly/TMlsTL, will allow patients to be treated sooner when they are much more likely to benefit.
"Sjogren's patients get diagnosed too late," says Julian L. Ambrus Jr., MD, professor in the Department of Medicine in the UB School of Medicine and Biomedical Sciences, an immunologist at Buffalo General Medical Center and senior author on the paper. "They go to the doctor because their eyes are dry or they can't swallow, but by that time, their salivary or tear glands are already dead. They're way past the point where they can generally benefit from any treatment."....
BRIEF COMMUNICATION (The Study )
Novel autoantibodies in Sjogren's syndrome
http://content.elsevierjournals.intuitiv.net/content/files/s1521661612002392-22104308.pdf
Last paragraph: (underline mine)
"The diagnostic criteria for SS and SD are undergoing con-
tinuous revision as more is learned about the pathophysiology of
these disorders. While Ro and La are autoantigens included in
the diagnostic criteria for SS, many studies have identified
patients with autoimmune SS and SD that do not have these
autoantibodies
[25
–
28]
. Other autoantibodies such as the ones
described in this manuscript may identify other subsets of
patients and/or patients at different stages of the disease. One
of the current challenges in SS and SD is to identify patients
early enough so that therapy can result in recovery of their
salivary and lachrymal glands. The autoantibodies to SP-1, CA6
and PSP may be helpful in this regard. New concepts regarding
early events in SS and SD may provide therapeutic targets once
these patients are identified.
"...because Sjogren's Syndrome presents with various symptoms, unlike other autoimmune diseases, this diagnostic test will be marketed to several different types of physicians, including dentists, oral surgeons, ophthalmologists and rheumatologists." http://www.newswise.com/articles/view/597254/?sc=rsmn
We have heard from many posters who have not been Dx'd due to standard SJS criteria, yet, have symptoms. Some Drs will treat others will not.
As it is possible that as per information sited that those not having Ro/La may be in earlier stage, I would self-advocate and present this to your Dr.
Hopefully this test will:
-provide treatment early to stave-off progression and damage
- putting the test into the hands of DDS, Opto, Rhuem, provide for more expedient opportunity for testing.
-help Drs better ascertain when more investigation should be done, in the event this test is negative...so that another medical issue is not missed.
New Sjögren's Antibody Discovery Improves Diagnosis
December 27, 2012 By Janice M. Epstein
With the approach of the new year also comes new hope for those with Sjögren's syndrome. A recent discovery of a new autoantibody associated with Sjögren's syndrome is leading to the development of a new diagnostic test that will more accurately identify a diagnosis of Sjögren's early in the disease process. This finding will pave the way to improved identification and treatment of this devastating autoimmune illness. Many of our PROSE patients with Sjögren's syndrome have been through a long journey of diagnosis and maintain hope that future Sjögren's sufferers won't have to endure a similar path.
Sjögren's syndrome is a chronic autoimmune disease in which the body's own cells attack moisture producing glands as well as other organ systems resulting in dry eyes and mouth, fatigue, and organ dysfunction. This disease affects as many as 4 million Americans with an estimated additional 3 million more cases undiagnosed. At present, there is no single definitive diagnostic test for diagnosing Sjögren's, only a set of diagnostic criteria, which makes diagnosis an often difficult and lengthy process for patients. When patients do not get an accurate diagnosis upon early onset of symptoms, effective treatment is delayed. This delay can seriously impact a patient's quality of life, cause undue stress and anxiety, and result in irreversible damage to organs and glands. Due to the significant impact of a delayed diagnosis, the Sjögren's Syndrome Foundation (SSF), a leading Sjögren's patient support and advocacy group, has set their sights on reducing the time to diagnosis by 50% in the next 5 years.
....these new antibodies were found in 45% of patients who met the current clinical criteria for diagnosis but did not test positive for the current antibodies used for diagnosis. At least one of the newly discovered antibodies was found in 76% of patients who were symptomatic for less than two years, yet lacked the disease markers Ro or La..." http://blog.bostonsight.org/index.php/2012/12/new-sjogrens-antibody-discovery-improves-diagnosis/
What is this "magic treatment" that they can use if this is diagnosed early though? Does not mention that unless I missed something.
Good question gardenlover! I thought there was no medication to halt or slow the progression of this disease! I would really like to know what can stop the glands from being "destroyed". I also read in one of my books that the glands aren't totally destroyed and that SJS patients are left with 1/2 of their glands even after many years of disease.
Quote from: gardenlover on March 26, 2013, 07:29:30 PM
What is this "magic treatment" that they can use if this is diagnosed early though? Does not mention that unless I missed something.
The success is the achievement of an early test, pre the occurrence of antibodies Ro and/or La. It is not even dependent on ANA as a screening tool.
I am just happy at the prospect of people being diagnosed early and/or catching those who have symptoms, which have prompted them to seek medical attention, yet, they fall through the crack as they do not meet current criteria, thus may not receive treatment.Example:
Early dental: "One of the most important consequences of oral dryness is the loss of teeth
. Saliva has multiple functions within the oral cavity that include: lubrication of the mucosa
•so that the tongue can help with cleaning out residual food that leads to dental plaque and bacteria;
buffering of acids that reabsorb calcium from teeth; as well as the ability to modulate viral, bacterial, and fungal populations in the mouth.
The loss of teeth in SS patients results from a combination of low oral pH that facilitates
loss of dental calcium and the alterations of oral flora that lead to accelerated decay
The mainstay in the prevention of dental caries remains fluoride. A high dose 5% sodium fluoride varnish is currently available in the United States, but apparently not as widely used in the United States as in Europe...
The theoretical advantage of using the varnish is not only in the level of fluoride but also in the sustained release delivery system. One gel application of the varnish could release fluoride for up to 6 month.. and can be applied directly to the root and incisal surfaces that are most vulnerable to decay in the SS patient population.
http://www.robertfoxmd.com/SjogrensByFox/Dermatologic_Manifestations.pdf
hydroxychloroquine: From a study done on Lupus pts. (pg.5)
"In the LUMINA (Lupus in Minorities, Nature versus Nurture) cohort, hydroxychloroquine use was associated
with reduced accrual of new damage. Patients with no evidence of prior damage benefited the most, which seems
to suggest that early initiation of hydroxychloroquine potentially maximizes its benefits."
http://211.144.68.84:9998/91keshi/Public/File/7/8-9/pdf/nrrheum.2012.106.pdf
For myself the thought of those benefiting from this test and not having to wait the average 7-10? years for Dx, and to have a chance for treatment and not have damage due to chronic inflammation ...is huge.
The mental and emotional stress to themselves and family.
If as is estimated there are 4 million of us and 3 million more un-dx'd...the socioeconomic cost is a major factor.
Numbers do drive research.
Also, since the heredity/gene issue is there. This is a way to catch SJS early. We have autoimmune disease in my family, ITP...and in hindsight 'I do wonder if my mother had SJS', to-date we are at 5 females with thyroid disease, etc. The ability to have this early test given by a dentist or ophthalmologist is a relief. I hope Drs. will be receptive to it.
Couldn't have said it any better Quietdynamics! I just printed out both articles and dropped them off to my rheumy today. Can't wait what he has to say since he's beeing so difficult on diagnosing me.
Having a more sensitive serology for Sjogren's is great, even if the false-positive rate is crazy high. (I didn't see specificity discussed in the article.) Even if these blood tests are inaccurate, a positive result gives doctors a warm fuzzy feeling, and hopefully, they'll be more likely to treat.
Styx
Quote from: Styx on March 27, 2013, 01:07:19 PM
Having a more sensitive serology for Sjogren's is great, even if the false-positive rate is crazy high. (I didn't see specificity discussed in the article.) Even if these blood tests are inaccurate, a positive result gives doctors a warm fuzzy feeling, and hopefully, they'll be more likely to treat.
Styx
Not sure what you are alluding to in your post?
The beauty of the test is the early detection with extreme specificity, measuring 3 antibodies (there is no False-positive). The study is posted under Brief Communication: The Study.
"... a positive result gives doctors a warm fuzzy feeling, and hopefully, they'll be more likely to treat"
A positive result gives Drs. and actually dx, rather than an educated guess, from which to set treatment protocol.
I remember my Rhuem having my 'positive results" looking concerned and somewhat sad for me.
Quote from: quietdynamics on March 28, 2013, 01:33:33 PM
Quote from: Styx on March 27, 2013, 01:07:19 PM
...
Not sure what you are alluding to in your post?
The beauty of the test is the early detection with extreme specificity, measuring 3 antibodies (there is no False-positive). The study is posted under Brief Communication: The Study.
"... a positive result gives doctors a warm fuzzy feeling, and hopefully, they'll be more likely to treat"
A positive result gives Drs. and actually dx, rather than an educated guess, from which to set treatment protocol.
I remember my Rhuem having my 'positive results" looking concerned and somewhat sad for me.
Considering that study doesn't have a control arm, how did they measure specificity? I don't see anything in the linked articles to support what you wrote above, but perhaps I missed it.
A true-positive gives a doctor a diagnosis.
Styx
Per my original post:
BRIEF COMMUNICATION (The Study )
Novel autoantibodies in Sjogren's syndrome
http://content.elsevierjournals.intuitiv.net/content/files/s1521661612002392-22104308.pdf
The control is on pg. 4. Figure 2... See graph C.
Graph F showing percent positive for "novel anti-bodies" lacking Ro and/or La.
Doh. I missed it. Thanks, quiet.
The specificity is not too bad at all. This looks very promising.
Styx
SS-A or anti-Ro aren't very good indicators of Sjogren's anyway - almost half of lupus patients are anti-Ro positive and this antibody is associated with the extreme photosensitivity so many with SLE have. An antibody unique to Sjogren's would be helpful if many people test positive for it once this is widely available. We're still waiting to see what symptoms of Sjogren's I develop in addition to my SLE - we suspect it but I can always hope we're wrong!
Hooray for the researchers! It is my hope that the use of lip biopsies to diagnose Sjs can fade into extinction . . .
Does anyone know if this test is available yet?
Good timing on your question.
I sent one of the scientists, Julian L. Ambrus Jr., MD, an inquiry and Thank you note for his research on June 21.
He wrote back. Just learned MIL may know his family in Buffalo.
"The tests were recently approved by NYS and are available through Immco
Diagnostics. I have attached an order sheet for you. ...There will hopefully be some new forms of therapy soon.
Julian"
Julian L. Ambrus Jr., MD
Division of Allergy, Immunology and Rheumatology
SUNY at Buffalo School of Medicine
Room C281, Buffalo General Hospital
100 High Street
Buffalo, NY 14203
It has been stressful here with my mothers legal issues, I am going to send a follow up to Immco for information.
Immco has three tests for Sjogrens #'s 076,093,097
*I do not see how to attach a PDF here, which is what was sent to me.
I would think that this would help a lot of those whose current blood work is coming back negative. Very exciting.
Ro and La?? What is that??
ImmcoDiagnostic: Early Sjogren's Syndrome Profile (includes tests 094, 095, and 096)
On the left hand side is the request form ...so you would have to discuss this "new" test with your Doctor.
http://www.immco.com/lab-services/search.aspx?Param=Code&Search=093
Quote from: jazzlover on June 28, 2013, 07:44:17 PM
Ro and La?? What is that??
American-European Consensus Sjögren's Classification Criteria
VI. Autoantibodies (at least one)
Anti-SSA (Ro) or Anti-SSB (La)
http://www.sjogrens.org/home/research-programs/healthcare-providers/diagnosis-criteria
How do we find out if Canadians can take this or if it is available in Canada?
I think this is so important. Obviously by the time it shows up in our blood we are quite sick. I do not want to do what the drs now want me to do, which is go off meds until I get sick enough to show + bw or become horrendously dry. Not cool, lovely rheumy. Not cool.
The test won't be available until next year.
It will be interesting to see how widely it is available and if docs start to use it. First though I think you'd have to find one who would even consider SjS when making a diagnosis.
Plaquenil is supposed to help slow the progression and mitigate symptoms (I have much less fatigue since I've been on it).
4kids...
Your question about scope of availability is what I was wondering about when I read the response from the Dr. Ambrus.
I am going to write to Immco for clarification. You can do the same.
I did find an extensive study done in Norway on Sjogrens that used Immco. Not this newer test.
This would be a good diagnostic to verify or rule out Sjogrens.
One can google/search "disease that mimic Sjogrens", "Sjogrens mimickers" (symptoms),etc.
Quote from: SjoGirl on June 29, 2013, 10:55:44 AM
The test won't be available until next year.
It will be interesting to see how widely it is available and if docs start to use it. First though I think you'd have to find one who would even consider SjS when making a diagnosis.
Plaquenil is supposed to help slow the progression and mitigate symptoms (I have much less fatigue since I've been on it).
SjoGirl ...Why do you say that? The Dr. sent me the test request form from Immco. And Immco has them on their site.
"
Sjogren's Syndrome: New Discovery by UB and Immco Makes Early Diagnosis A Reality for the First Time
The new diagnostic test will be available to physicians in early 2013
By Ellen Goldbaum
Release Date: December 12, 2012
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"The vast majority of patients we tested who have early symptoms. . . also have these antibodies," says Ambrus (right), co-author with Long Shen, both of UB.
*
BUFFALO, N.Y. -- Patients suffering from the painful autoimmune disease, Sjogren's Syndrome, will soon be able to be properly diagnosed much earlier, thanks to the discovery of novel antibodies by researchers at the University at Buffalo and Immco Diagnostics, Inc. The breakthrough, described in a paper in the December issue of Clinical Immunology will allow patients to be treated sooner when they are much more likely to benefit.
"Sjogren's patients get diagnosed too late," says Julian L. Ambrus Jr., MD, professor in the Department of Medicine in the UB School of Medicine and Biomedical Sciences, an immunologist at Buffalo General Medical Center and senior author on the paper. "They go to the doctor because their eyes are dry or they can't swallow, but by that time, their salivary or tear glands are already dead. They're way past the point where they can generally benefit from any treatment."
The new antibodies were seen in 45 percent of patients who met most of the clinical criteria for Sjogren's except for the antibodies currently required for diagnosis, called Ro and La. At least one of the novel antibodies is present in 76 percent of patients who have had symptoms for less than two years and who also lacked the two antibodies required for definitive diagnosis, which appear late in the disease.
"The vast majority of patients we tested who have early symptoms of severe dry mouth and dry eyes also have these antibodies," says Ambrus.
The journal highlighted the research paper with an editorial by Robert I. Fox, MD, PhD, of Scripps/Ximed, considered one of the world's top Sjogren's Syndrome scientists.
Considered one of the three most common autoimmune diseases, Sjogren's Syndrome affects more than 4 million Americans, 90 percent of them women; last year, Venus Williams, the tennis champion, announced that she had the disease. Symptoms are dry eyes and dry mouth so severe that they are painful. Despite its high incidence, Sjogren's is not well-known and can take years to diagnose; once diagnosed, it is often too late to effectively treat it.
Beyond the chronic pain associated with not being able to produce tears or saliva, the disease is associated with additional, systemic consequences, such as mild kidney and lung disease. Five to 10 percent of Sjogren's patients also will develop lymphoma, cancer of the lymphocytes, a type of white blood cell that is continually produced in Sjogren's Syndrome.
The discovery of novel antibodies grew out of a strong collaboration between UB and Immco, which in 2006 resulted in a new, far superior animal model for Sjogren's Syndrome.
"Our animal model has completely changed how people think about this disease," says Ambrus. "Sjogren's disease in our animal model marches along in exactly the same way that the human disease does, reproducing every stage of the disease."
Labs studying Sjogren's around the world have now adopted the new model developed at UB and Immco, which is based in Amherst.
Once the new antibodies were detected in mice, the scientists started testing human patients at Buffalo General Medical Center. The researchers found the same antibodies in humans even at early stages of the disease.
UB has filed a patent on the biomarker-based method and licensed the technology to Immco, which has developed a new diagnostic tool based on the research.
"We believe this is one of the most undiagnosed autoimmune diseases," says William Maggio, Immco's chief executive officer.
The new diagnostic tool his company developed for Sjogren's Syndrome has significant proprietary value. "We will be the only company in the world to offer and market this test across any platform," he says.
And because Sjogren's Syndrome presents with various symptoms, unlike other autoimmune diseases, this diagnostic test will be marketed to several different types of physicians, including dentists, oral surgeons, ophthalmologists and rheumatologists.
The assay will undergo validation by the New York State Department of Health. Once complete early next year, physicians will be able to start using the test. Patient samples from around the nation will be sent to Immco for testing. Immco also is developing a diagnostic kit for customers to be marketed internationally."
http://www.buffalo.edu/news/releases/2012/12/13854.html (in original post)
Hum, sorry if I've caused confusion. I thought for sure when I attended the SjS Foundation patient conference this year that they said the test would not be available until next year. I may have misunderstood.
Quote from: SjoGirl on July 01, 2013, 03:10:34 PM
Hum, sorry if I've caused confusion. I thought for sure when I attended the SjS Foundation patient conference this year that they said the test would not be available until next year. I may have misunderstood.
SjoGirl what was the attitude towards the test? Any input at the conference?
Bump for those about the new testing available.
Here is the communication I received from IMMCO.
The attachments are PDF, I cannot convert them to copy..so I scanned and am posting that way.
Good morning Barbara
Thank you very much for your e-mail. We are always pleased to hear from our community and hope that our work proves to be meaningful for sufferers of autoimmune disease and, like you said, that research keeps evolving.
I have attached an information sheet we prepared on the novel markers for Sjogren's Syndrome that I hope provides you with the information you are looking for. There is information on the test panels we offer on the back of the information sheet as well as how to submit samples although I have also attached the Sjogren's specific test request form. Your doctor would be the one responsible for ordering the test. He/She needs to fill out the test request form and we will send them in return a collection kit. Once the samples are collected they simply return to us and we provide them with the results.
The Tests Panels are as follows:
New tests:
093 : Early sjogren profile (includes 094-sp1;095-cA VI and 096 –PSP) Cost is of $330 dollars
097: comprehensive Sjogren profile (profile (includes 094-sp1;095-cA VI and 096 –PSP, 001 ANA, 011 RF,045 SSA,046 SSB, 7 511 H & E minor salivary glands)
Modification of old tests:
076 : Sjogren's syndrome profile: will now include 094,095 and 096 in addition to 001,011,045 and 046
You can also find more information on each specific test from our website: http://www.immco.com/lab-services/test-services.aspx (diseases listed alphabetically)
Please let me know if there is anything else I can help you with.
All the best,
Lourdes Vazquez-Mitchell, M.Sc.
Product Manager
Nova Century Scientific, Inc.
An Immco Diagnostics Company
* scans in next posts, so if someone can do it better, we can just remove.
Ok this is not going to work.
Does someone have a way to post these?
They are the Information about the test to take to Dr. and the actual Lab Request.
Thank you.
Have these been posted somewhere?
I really wanted to do this test as my lip biopsy was a bust and SS-A and SS-B neg. My ENT seems like she is still itching to do another biopsy as she seems very perplexed by my results. I am hoping to avoid this, but would like some definitive answers. I was able to print lab info directly from IMMCO's site. I also printed out the article that was from a med journal I believe that was linked through this or a similar thread and presented this to my Rheumy. She approved this for my next round of blood work in October. I'll let you all know.
That's great. Will be really interested in hearing the results.
The test is from blood. I was quoted $330.
Email response from Immco:
The Tests Panels are as follows:
New tests:
093 : Early sjogren profile (includes 094-sp1;095-cA VI and 096 –PSP) Cost is of $330 dollars
097: comprehensive Sjogren profile (profile (includes 094-sp1;095-cA VI and 096 –PSP, 001 ANA, 011 RF,045 SSA,046 SSB, 7 511 H & E minor salivary glands)
Modification of old tests:
076 : Sjogren's syndrome profile: will now include 094,095 and 096 in addition to 001,011,045 and 046
You can also find more information on each specific test from our website: http://www.immco.com/lab-services/test-services.aspx (diseases listed alphabetically)
Please let me know if there is anything else I can help you with.
All the best,
Lourdes Vazquez
Lourdes Vazquez-Mitchell, M.Sc.
Product Manager
Nova Century Scientific, Inc.