"New Fibromyalgia Blood Test is 99% Accurate"

Kyla

ᴀɴɴɪᴇ ɢꜱᴀᴍᴩᴇʟ
Messages
721
Likes
4,207
Location
Canada
http://nationalpainreport.com/new-fibromyalgia-blood-test-is-99-accurate-8821072.html

Anyone know anything about this or whether this "99% accurate" test is hype or the real deal?
It says there is a journal article with the results coming "in the next few months"

Surprised this is the first I've heard of it as I think quite a few on here have co-morbid FM?


Excerpt:
New Fibromyalgia Blood Test is 99% Accurate
Posted on July 30, 2013 in Diseases & Conditions

A new blood test for fibromyalgia is more accurate than previously thought and will not confuse the chronic pain disorder with other diseases such as lupus and rheumatoid arthritis, according to the physician who developed the test.

“We have not seen any overlap between the biomarkers in fibromyalgia and the immune system patterns of patients with rheumatoid arthritis or lupus. That really takes the air out of the sails of any naysayers that are out there,” said Bruce Gillis, MD, founder and CEO of EpicGenetics, a bioresearch company based in Santa Monica, CA.


EpicGenetics introduced the FM test in March, calling it the first definitive blood test for fibromyalgia, a poorly understood disorder that is characterized by deep tissue pain, fatigue, headaches, depression and lack of sleep. Test results are usually available in about a week.

The FM test looks for protein molecules in the blood called chemokines and cytokines, which are produced by white blood cells. Fibromyalgia patients have fewer chemokines and cytokines in their blood, according to Gillis, and as a result have weaker immune systems than normal patients.

Critics have said the same immune system biomarkers can be found in people with other illnesses, such as rheumatoid arthritis, making the blood test unreliable.

However, in new research involving over 300 patients with either fibromyalgia, lupus or rheumatoid arthritis, Gillis said only fibromyalgia patients were found to have below normal levels of chemokines and cytokines...
 

Valentijn

Senior Member
Messages
15,786
Likes
45,660
Anyone know anything about this or whether this "99% accurate" test is hype or the real deal?
It's probably being grossly over-hyped for commercial reasons.

Basically they're saying that a pattern of lab results diagnoses FM, based solely on one or maybe two research papers which they have produced. This really is not even close to being a proper diagnostic test yet. Especially since it relies largely on cytokines, which tend to be all over the place in various disease with an inflammatory component.

For comparison, we've had dozens of papers showing cytokine abnormalities in ME/CFS. But they aren't nearly consistent enough to say that any specific pattern gives a firm "yes" or "no" for individual diagnosis, though they do show objective proof of biomedical dysfunction.

In addition to a lot more replication, they need to compare it to a lot of other diseases. It's not good enough to just say that it's not the same pattern as they have seen in RA or Lupus.
 

Kyla

ᴀɴɴɪᴇ ɢꜱᴀᴍᴩᴇʟ
Messages
721
Likes
4,207
Location
Canada
It's probably being grossly over-hyped for commercial reasons.

Basically they're saying that a pattern of lab results diagnoses FM, based solely on one or maybe two research papers which they have produced. This really is not even close to being a proper diagnostic test yet. Especially since it relies largely on cytokines, which tend to be all over the place in various disease with an inflammatory component.

For comparison, we've had dozens of papers showing cytokine abnormalities in ME/CFS. But they aren't nearly consistent enough to say that any specific pattern gives a firm "yes" or "no" for individual diagnosis, though they do show objective proof of biomedical dysfunction.

In addition to a lot more replication, they need to compare it to a lot of other diseases. It's not good enough to just say that it's not the same pattern as they have seen in RA or Lupus.
Ah. Didn't notice it was cytokines.
I think probably didn't pan out if no one has heard anything more about it.

might be interesting to know if their cytokine results are consistent or divergent with the ones in ME/CFS. Since there are a lot of attempts to lump them together.
 

CFS_for_19_years

Hoarder of biscuits
Messages
2,396
Likes
5,880
Location
USA
The test is available at https://thefibromyalgiatest.com.
https://thefibromyalgiatest.com/?p=7956
We’re pleased to announce that many insurance carriers, including Blue Shield of California and Medicare are now reimbursing for FM/a® – The FM Test. EpicGenetics will assist you at no cost to determine whether your insurance or Medicare coverage and benefits will pay for the cost of the FM/a® – The FM Test. Please click here and complete the form to get started. Our insurance department can be reached at billing@epicgtx.com, or at 855-504-4045, with any questions.
Before anyone jumps on that, please read the comments by Fred Wolfe:
http://www.fmperplex.com/2013/02/25/junk-science-junk-ethics/#comment-334

The FM Diagnostic Test
As a preliminary report, your BMC paper is of considerable interest. You make some assertions about fibromyalgia that I might not agree with, but that is your right. My concern is with the extrapolation of the data from your study to a diagnostic test. I will only comment on a few problems.

1) Diagnostic tests have an intended population: patients for whom the diagnosis is uncertain. So, patients with pain or some fibromyalgia symptoms would be the intended population. But your controls were “healthy donors.” It is not possible to estimate diagnostic properties of a test when the control population is not the population that the test will be used upon. Note the various American College of Rheumatology studies employed substantial pain controls.

2) Second, it is necessary to explore illnesses that are similar to fibromyalgia or have symptoms that common to fibromyalgia to determine if the test is specific to fibromyalgia.

3) The characteristics of the fibromyalgia subjects are important. We have no way of knowing how typical your subjects were.

Based on these three items, I conclude that you do not have sufficient data to determine a measure of test accuracy regarding differentiating fibromyalgia from patients with similar non-fibromyalgia disorders.

Here are some of your statements and claims that I found on your web site.

Statement: This novel cytokine assay reveals unique and valuable immunologic traits, which, when combined with clinical patterns, can offer a diagnostic methodology in FM.

Comment: “combined with clinical patterns?”

Statement: FM/a® is a multiple biomarker-based test, which measures protein molecules called cytokines within white blood cells, a key part of your immune system. People with significantly lower cytokine levels have fibromyalgia. It uses a 1-100 point scoring system to determine diagnosis, and it calculates a positive fibromyalgia diagnosis as a score between 50 and100 points.

Comment: Impossible from your study sample.

Statement: FM/a® is more than 93 percent sensitive, a sensitivity comparable to the HIV blood test. By comparison the rheumatoid arthritis blood test is only 65 percent sensitive. No medical test is 100 percent accurate.

Comment: Impossible from your study sample

Statement: Fibromyalgia and Chronic Pain Questionnaire

Comment: With your pain questionnaire you already have most of the diagnosis.

Statement: Who should have “The Fibromyalgia Test – FM/a ®”

If you have a personal medical background where you possess some or all of the recognized manifestations of fibromyalgia for several months or longer, then after discussing with your doctor and healthcare professionals your symptoms, you are a candidate for this test which can confirm the diagnosis of fibromyalgia in you. The specific traits of fibromyalgia include:

Comment: you didn’t test those with some of the symptoms. Based on the data you have, you did not test how well you could diagnosis fibromyalgia.

Statement: Those who have previously been diagnosed with FM may want to have the test because — until you have the test — you cannot be sure that your diagnosis has been accurately confirmed.

Comment: simply not true.

Statement: Also, once a baseline level of FM activity has been achieved via your test score, you and your doctor can monitor the effectiveness of your treatment via objective parameters- hence you will know whether you are improving due to that therapy or not versus just feeling better because of a placebo effect.

Comment: You have no data on this point.

Statement: One may also want to consider having the test to potentially eliminate other diagnoses — like depression — being made incorrectly.

Comment: You have no data on this point.

Stement: “The Fibromyalgia Test – FM/a ®” has made what will no doubt be the first breakthrough in diagnosing, understanding and treating this medical illness.

Comment: No doubt?

Statement: The FM/a® Test is the first test to objectively diagnose fibromyalgia via a simple blood test, with results usually available in one week or less.

Comment: Simply not true with your data.

Statement: The FM Test fundamentally shifts the way fibromyalgia is perceived. Previously, fibromyalgia was thought to be a syndrome (subjective collection of symptoms), but The FM Test proves that fibromyalgia is an immune system disorder and a real disease.

Comment: Simply not true with your data.

The FM Test is sensitive to more than 93 percent, a high degree of accuracy.

Comment: Simply not true with your data.
The comments continue at http://www.fmperplex.com/2013/02/25/junk-science-junk-ethics/#comment-334
 
Messages
5
Likes
12
I just took this fibromyalgia blood test. I was diagnosed with fibromyalgia 18 years ago but was sick for years before being diagnosed. I thought my symptoms were more typical of CFIDS because I am not in chronic pain all the time but exercise crashes can be VERY severe. However, I just got my results back from EpiGenetics and I am strongly positive. Anything over 50 is positive and I came in at 83.

I enourage everyone on this forum who has insurance that will cover to ask your doctor to order this test. Medicare will pay for those who are retired and if you don’t have a doctor, EpiGenetics will have one of their own doctors order it for you. They arrange for a phlebotomist to come to your house to draw the blood sample, and the phlebotomist also overnights it to the lab.

EpiGenetics needs more men to test and also younger people. Most of the testees have been older women, like me.

They are now working with Massachusetts General Hospital to set up a clinical study and need more MEN volunteers.

Please pass this on to everyone you know with a CFS or Fibro diagnosis.