CORRECTION: This test is not in the oversight of FDA as I originally wrote on 12.6.17. The corrected version follows, with my correction in bold type face. Apologies to everyone for my error. – Laura 12.13.17
Do you have MS? Then you most likely underwent all the necessary testing for your diagnosis. The tests were pretty simple, right?
Clinical exam? Check.
Blood test? Check.
Personal history? Check!
MRI’s? Of course, check!
Lumbar puncture (aka spinal tap)? Unfortunately most of us had to check off that test as well and is the one MS test that is definitely not simple or stress free. Just the name alone conjures up images of torture involving needles.
The LP is used to check of o-bands in the blood serum that indicate a demyelinating process stripping the myelin in our central nervous system. And until now, it has been the only biological test used to support a diagnosis of MS. Even with the LP and a positive reading, it was only 80% positive for MS
Now there is another way to get this important confirmation and although it still involves needles, they are much smaller and just used for a simple blood draw instead of a spinal tap.
A Small Company with Big Potential
iQuity, a young biotech company in Nashville, has FDA approval for a blood test that indicates MS. It’s still pretty much unknown in the clinical world, but their work is so solid they secured a major funding grant from the National Institute of Health (NIH) this year. We would expect this test to be adopted quickly, to replace the LP, especially since it has been shown to be >92% accurate, compared to the 80% rate for testing the spinal fluid. But that isn’t happening yet.
Payers, the insurance companies and even the federal insurers like Medicaid and TriCare, do not reimburse for this test, even though it is approved as a Laboratory Developed Test (LDT). LDTs are overseen by the Clinicial Laboratory Improvement Acts (CLIA), and are governed by the Centers for Medicare and Medicaid Services.
That’s discouraging to know something like this simple blood test that would be more patient friendly AND accurate than the lumbar puncture is not being widely used because of the cost.
Outreach to Bloggers
iQuity hosted a one-day conference in Nashville for key opinion leaders in the MS community, and I had the honor of attending along with some of the best names in the MS blogging world. Disclosure: iQuity paid for our travel, hotel and incidental expenses, and spent the day sharing their access to MS experts with us.
We heard about the importance of MS physical therapy from Jennifer Meyer, PT, DPT, NCS,Vanderbilt University Medical Center. This reinforcement of why we need to do more physically, whatever that may look like for the individual, is always good.
Dr. Ram Sriram, Professor of Neurology and Immunology Head of the Neuroimmunology Division, also Vanderbilt, shared his latest studies involving remyelination, which by the way seems to be helped by exercise.
The day concluded with Dr. Daniel Kantor sharing his tips on successful use of social media to disseminate information back to the people in our community. The full day program was informative and insightful and as always, I learned new things.
IsolateMS one of Three IQ Tests
But the most informative part of the program was being able to talk with Chase Spurlock, PhD, CEO of iQuity, and ask him questions about their IsolateMS test, and IQ Isolate autoimmune disease diagnostic tests. Dr. Spurlock is a young man in the research world, compared to the usual researchers who have spent decades in a laboratory. He has his Ph.D., in Microbiology and Immunology from Vanderbilt University, Nashville, Tennessee and is a research instructor on their faculty.
I’ve come to know iQuity and the work being done by Chase and his co-researchers via the Accelerated Cure Project and iConquerMS. His laboratory benchwork used biological samples from ACP’s repository program. I first met Dr. Spurlock at an MS neurology conference two years ago, before IQ Isolate was approved by the FDA.
I won’t pretend that I understand all the science involved in this test that looks at our DNA and the RNA in our blood, and compares it to an algorithm that has been proven to demonstrate MS, and instead focus on his enthusiasm for this test and the 92% accuracy rate, Both of those are good markers to me that IsolateMS is groundbreaking.
Out-of-Pocket Cost a Challenge
IsolateMS can possibly save months and even years of time for people who are ill but can’t get a sure answer that it’s MS through the diagnostic methods used now. And we all know the faster a diagnosis can be made, the better the odds are that permanent disability can be delayed or even stopped through the use of disease modifying therapies.
In addition to IsolateMS, they also have Isolate IBD & IBS, and Isolate Fibromyalgia tests ready for the market.
Despite all these good things, don’t expect to see IQ Isolate tests in common use until insurance payers agree to cover the cost. The $1,000 cost for the test is often an expenditure many people can’t make. iQuity has worked out a payment plan through PayPal, trying to assist as best as they can. Now it’s a matter of getting the word out to doctors and patients that there is another option to the lumbar puncture.
Wishing you well,