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    Results of blood work for JCV 'index" risk

    I'm not sure how to word this post, so bare with me.

    I am +JCV, had blood work last week for a 'new' test to determine my risk of develping PML.

    I as notified by MS doc's office today that based on lab results my 'JCV index' was 1.81, versus the ?threshhold? JCV index of .50.

    My MS doc did the pitch during my office visit for me to switch from TY to BG-12? when the blood work was ordered.

    Anyone understand what the results of my blood work mean and/or how to interpert JCV 'index' numbers, my JVC index of 1.81?

    #2
    I'm confused by no responses....

    Has anyone heard of this blood test to determine your JCV Index?

    My neuro appointment was apprx 05/06, we discussed switching to BG-12 because of my +JCV status, and the new JCV 'Index' available to determine risk of developing JCV.
    The blood work was paid for by Biogen, blood drawn on approx. 05/10.

    I got a call from my neuro 05/23 to discuss the results, but missed his calls. With the holiday weekend I will talk with him Tuesday.

    I'm more curious no one else has heard of the new 'Index', assigning a numerical rating based on the risk of developing JCV.

    Comment


      #3
      The regular STRATIFY JCV test is supposed to identify the risk of PML by determining positive from negative. People who test negative are at a lower risk for PML and people who are positive have a higher risk. The test uses an index number to cut off positive from negative.

      How is the test you had different from the regular test for just determining positive from negative and what is it supposed to find out that's different from the regular antibody test? What did your doctor say about it when he convinced you to have the test?

      If the test is approved by the FDA there should be information available about it somewhere. There doesn't seem to be anything online about a new test - newer than the regular STRATIFY test - so it makes me wonder if its some new test that Biogen is working on that hasn't been approved yet. If its still experimental then that might explain why nobody knows about it yet.

      When you found out you're JCV positive what test did you have? Was it before the STRATIFY test was approved in 2010? If you had a different test then I'm wondering if the test you just had might be the "official" STRATIFY test and your doctor wants a more reliable result than the first test? If its the regular STRATIFY test then a number bigger than the index number just means that your JCV positive which makes your risk of PML higher than for a negative. If its a different test then it might be an experimental one and nobody knows what the index number means.

      Comment


        #4
        I've had the regular blood draw at the infusion center, per Ty protocol since starting infusions +2yrs ago. I've had a few additional blood draws based on changes in my clinical exams.

        My understanding is this test is very new, for those who are known to be +PML, to identify PML positive patients who at a higher risk of developing full blown PML.

        The blood draw was done at Quest Labs, not at the infusion center or hospital lab where my blood work is typically done.

        I received paperwork on Biogen letterhead instructing Quest Labs to bill Biogen for the lab work. The results were sent to Biogen and my doc's office contacted Biogen directly for the results.

        After missing my doc's call, I talked with one of the nurses who read the results, mine being 1.81, the threshold? being
        0.5.

        I thought this test was being widely done for all +PML patients on Ty.

        Comment


          #5
          An ELISA (enzyme-linked immunosorbent assay) was developed as a tool for stratifying MS patients for higher or lower risk of developing PML. The test was approved by the FDA.

          "A second-generation ELISA (STRATIFY JCV™ DxSelect™) for detection of JC virus antibodies in human serum and plasma to support progressive multifocal leukoencephalopathy risk stratification."
          http://www.ncbi.nlm.nih.gov/pubmed/23465394

          The link below mentions the assay index cut points as follows:
          <.20 Negative (JCV-)
          .20 to .40 Indeterminate (could be JCV-, or JCV+)
          >.40 Positive (JCV+)
          http://www.sciencedirect.com/science...86653213000425

          You can download a pdf about the test at the link below but you will still need an interpretation from your doctor. There are various ways individual doctors have of interpreting test results so patients can understand them. They may refer to titers, an index, optical density, copies per ml, or they may do the math and come up with a number like 4.3 out of 1,000 for a risk factor. Every one of those involves a number.

          But numbers can be very, very misleading if the context is not precisely known. For example, if all you know is a number like 4.3 does it refer to copies per ml, titers, or that people with similar test results have a risk of 4.3 out of a thousand of getting PML? TRUST YOUR DOCTOR TO INTERPRET YOUR TEST RESULTS!! Everybody on Tysabri will have this assay done, I’m sure.
          http://www.focusdx.com/pdfs/pi/US/EL1950.pdf

          Comment


            #6
            Myoak, thanks so much for the info and links. I'm exhausted at the moment, I will read the links later.

            MSer102, appreciate your response too.

            Many thanks again for replying.

            Comment


              #7
              The STRATIFY test is what I was talking about earlier. It looks like the "new" version is more sensitive and easier to use than the older one but it still only determines positive from negative. "Risk stratification" means that people who test positive for the JCV antibody have a higher risk of PML than people who test negative and we already knew that from the old test.

              What threw me was that you said the cut off index is .5 with the new test and that it's supposed to be something different and special. The "new" STRATIFY test cut off index is .4 so I thought you were talking about a different test. Since it's really the STRATIFY test - just new and improved - then poster Myoak is right that there's information about it available online. If I'd know that was the test you were talking about I would have posted the links for you.

              You already know that your JCV positive so you know the higher risk of PML apples to you. It will be interesting what your neuro has to say about what the "new and improved" test does that's different from the first version and what the test says about your risk of PML that you didn't find out from the first test.

              Comment


                #8
                MSW 1963,

                The post above is not accurate and is misleading.

                The poster said the new test (which she said she didn’t know existed) and I quote her, “still only determines positive from negative”. That statement is completely false!

                MSW1962 asked about the new test. It was developed and is used for stratifying MS patients for higher or lower risk of developing PML. This stratification is done by achieving a specific number from test results. The higher the number, the greater your risk. It is NOT merely a positive or negative test result; it is a number which can be compared.

                I was reluctant to use specific numbers in my reply to your question for the express reason someone would misinterpret them, which is exactly what happened in the above post. But I did stress that your doctor should be telling you the context of any numbers he uses to inform you of risk.

                I am not going to post any more specific numbers related to this new test. But I will tell you that Tysabri patients who developed PML had relatively high numbers compared to those not having PML. This was found with the new test using blood samples of PML cases. Specific number values were assigned using the new and more sensitive test and your test result number can be compared to those.

                If you have looked at the web-links it is obvious that the study which validated this new test was complex. It is so easy to misunderstand and misapply number values. Be sure your doctor is the one explaining this test and your specific results.

                Lastly, I would kindly ask to the previous poster to respect the fact that innocent people asking important questions are harmed, not helped by misinformation. Please be more careful and considerate. Everyone makes mistakes but habitually doing so points to a fundamental problem with integrity which over time has become apparent to most users and moderators of this site, I'm sure.

                There are ways to stroke your ego without playing games with critical health questions. I am asking the moderators to monitor this repetitious behavior and take whatever actions necessary to protect the integrity of this site in the interest of MS sufferers and caregivers. And, being a fairly sturdy lot, I believe they will.
                Thank You

                Comment


                  #9
                  Myoak, I appreciate you taking your time to set the record straight concerning this new PML test.

                  My doc left a detailed message for me when I missed his call on Thursday. He took great effort not to cause me undue concern or alarm. With the long holiday weekend, he assured me he would call again Tuesday to discuss the test results.

                  I returned doc's call within minutes, that's when I talked with 'the nurse' who gave me the numbers I referred to earlier in this thread. I have an appointment to talk with my doc on Tuesday and will update with any pertinent info.

                  Your time and effort is appreciated.

                  Comment


                    #10
                    Regular testing for JC+ ratings

                    I recently tested JC+ and have decided to stay on TY. Not sure if "rating" is the accurate word but my dr explained in previous tests they were not able to get the rating or titers and now they can so she couldn't tell me what I was when I was negative. Anyway I am 1.14 now, my Dr was able to consult with a DR doing the study for the JC+ titers (rating) and he recommended if I stay on TY to test every 3 months to watch If the titers start increasing and MRI every 6 mths. The mentioned study was supposed to be out in May 2013 however isn't ready for release yet. This doesn't make me any less stressed about PML I am still in a category of higher odds now that I meet all three of the categories that are a concern, 1. being more than 2 years on TY, 2. prev steroid and methotrexate use, and 3. JC+. I am trying to hope for the best and hang in here longer in hopes of watching what other therapies come out in the next year and to see feed back on on Tecfidera for a year. I have been relapse free for 56 treatments now and no new lesions. I am taking the "If it isn't broken don't fix it approach" and hoping If anything develops with PML It will be caught early. Best of luck to everyone.

                    Comment


                      #11
                      oceansmile, it's a relief to hear from someone else who's had the new PML test.

                      I'm not sure what my PML status was before starting Ty, but I did learn that I was PML positive over a year ago, and have been on Ty for just over 2yrs now.

                      I did stop Ty infusions but had awful rebound accompanied by lots of sudden progression. Two of my 3 worst sx's resolved in the first 3 months of staring Ty, so it's been a miracle drug for me in that respect.

                      I appreciate you sharing your experience, it's reassuring to hear from someone else. thanks again!

                      Comment


                        #12
                        Oceansmile and MSW 1963, thank you for talking about the important new JCV test. It is sure to become a critical part of every Tysabri treatment decision. Thank you so much for making your experience and knowledge available so we can learn from it.

                        This new test which stratifies PML risk is a huge step forward in making sound treatment decisions for those on Tysabri.

                        Oceansmile mentioned a doctor recommending testing every three months to monitor if titers (of JCV antibodies) are increasing. Obviously, if PML cases have high titers (they do) and others are relatively low and not increasing overtime then it is less likely PML will occur. If JCV titers are found to be increasing substantially doctors will halt Tysabri treatments. Remember, that Tysabri allowed replication and mutation of JC virus into a dangerous form which permitted development of PML in some MS patients.

                        It will be interesting to see if testing JCV titers every 3 months will become standard.

                        Separately, a treatment coming this year which looks promising is Lemtrada (alemtuzumab). It has side effect issues but all other FDA approved MS treatments do, also. Lemtrada may be approved Sept. or Oct. according to some. It may become an alternative for some patients if they discontinue Tysabri. Some trials showed Lemtrada being very effective.

                        Looking forward to your next post MSW1963. Thank you for anything you can tell us about your experiences and observations regarding this new test. I’m sure hundreds of people want to learn more about the test. Thanks a million for what you can share.

                        Oceansmile, great post, thank you so much!

                        Comment


                          #13
                          Am I understanding correctly?

                          Is this correct: the test that Biogen pays for from Quest labs is now a new test? Not only will you get a positive or negative result, but you also will get a better reading of how positive you are, meaning you could be just barely positive or way positive, which would maybe mean you were at an even higher risk for developing PML than if you were just a little bit positive? (Of course I put it in simple terms.)

                          Am I reading these post right?

                          I have had 50 infusions and am positive for the JC virus. Tysabri is the drug for me and I am not willing to give it up. With the information that I now have.

                          If I took a test that said, wow - you have tons of the virus in your system and you will probably get PML down the road, well, that certainly would change things.

                          Comment


                            #14
                            I talked with my doc yesterday about my +PML status and the recent new test developed to identify those who are positive for the PML virus who may be at greater risk of developing PML.

                            Based on my conversation with my doc, the test compares known PML cases and their titer 'scores' with those Ty patients who are positive for the PML virus. Ty related PML cases make for a small study group, so this may evolve as the study continues.

                            During my appointment 3 weeks ago my doc did the pitch for me to change to Tecfidera. This was a couple of days before the European publication of PML cases associated with it.

                            Yesterday he mentioned Gilenya several times and I brought up Tecfidera based on his earlier recommendation. Tecfidera is not yet on the Medicare list of approved meds. Doc thinks it might be a matter of a couple of months before it's approved by Medicare= my insurer.

                            I have my regular Ty infusion today. I plan to continue Ty untill I decide between the 2 meds discussed with my doc. Doc has a package for me at the infusion center with med info for me to review. My doc has it all together and all going on, love my doc. Today anyway.

                            Comment


                              #15
                              LL60, Sorry for the delay in reply. Yes, you are correct in understanding that the new test is more specific than the old test which was merely + or -. The new results expressed in titers may help patients and doctors decide whether to continue Tysabri or not.

                              Several people have mentioned that .9 is the value used to establish a mark between higher risk and lower risk of developing PML. I personally know patients who tested near 3.5 and continue on Tysabri so nothing is set in stone; it is still a matter of personal choice to continue or stop.

                              It is very difficult for those experiencing no disease progression and few to no side effects on Tysabri switching to a med which is not likely to be as effective and has awful side effects, too.

                              Historically, MS drugs often show more problems in a general population of patients than they showed in trials. And, of course, there are studies about studies which show bias tends to confirmed. In other words, a trial to confirm the effectiveness of a med will indeed confirm its effectiveness. Tecfidera comes to mind. From reading several boards it appears that tolerability issues affect many more than REPORTED in trials. Time will tell the truth.

                              Personally, I wonder if stomach cancer or significant GI issues will surface in a few years with Tecfidera. Tysabri is a perfect example of a serious issue surfacing years after people first began taking it in trials.

                              Tec will work for some, Ty will work for some, MS is very individual.

                              It would be interesting if those JCV+ and continuing on Tysabri made their titer number known from the new test. I’m guessing many having success on Tysabri will choose to continue treatment even with an elevated titer number. Every MS treatment has risk. Each person manages risk individually. No one size fits all.

                              Interesting topic. May I ask if about your decision, MSW1963? Best wishes for your every success!

                              It is important to keep in mind that JCV titers tended to spike dramatically in those who developed PML. Monitoring titers is a way of giving a heads-up if titers spike. Testing JCV titers is a good surveillance tool.

                              Comment

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