Showing posts with label biomarker. Show all posts
Showing posts with label biomarker. Show all posts

Wednesday, April 19, 2017

EpicGenetics Announces Major Clinical Study to Locate Genetic Markers Unique to People with Fibromyalgia and Explore New Treatment Approaches



EpicGenetics, with the Assistance of Leading Medical Centers, Expands Clinical Study of FM/a® Test to Diagnose Fibromyalgia, Identify Genetic Markers Unique to the Disorder and Explore Direct Treatment Approaches

- Provides Research Gift to the Faustman Immunobiology Lab at
Massachusetts General Hospital/Harvard Medical School to
Support Research on Fibromyalgia Treatments -

In February of 2016, I wrote a blog on the importance of a well-designed study on fibromyalgia, Are Fibromyalgia Researchers on a Common Path?

In June of 2016, I wrote a blog on my personal experience with the FM/a® blood test providing a detailed guideline on how the process worked for me, and my results.

In an article that will be published soon by ProHealth, I write about the chaos surrounding concrete diagnostic criteria and the disparaging consequences.

Breaking News

And now I am excited to write about new research that could very well provide us with a true understanding of a “disease” called fibromyalgia.

I have been waiting for permission to share what you are about to read.

LOS ANGELES – April 19, 2017 – EpicGenetics, a privately held biomedical company dedicated to improving the diagnosis and treatment of fibromyalgia, today announced that it has engaged the University of California, Los Angeles (UCLA)* and the University of Illinois College of Medicine Chicago (UIC). Both university research centers will be sequencing the exomes of patients to improve the diagnosis of fibromyalgia through the application of the FM/a® Test and to allow EpicGenetics to detect fibromyalgia disease-specific gene markers. Additionally, Bruce Gillis, M.D., CEO of EpicGenetics, has made a research gift to the Immunobiology Laboratory at the Massachusetts General Hospital directed by Denise Faustman, M.D., Ph.D., to continue its robust clinical research regarding a direct treatment for fibromyalgia. 

The FM/a® Test is an FDA-compliant blood test that diagnoses fibromyalgia by identifying the presence of specific white blood cell abnormalities that have been documented to exist in these patients. The FM/a® Test accurately and objectively diagnoses this chronic disorder that afflicts millions of men, women and children.


Committment

I have been committed to understanding and educating my peers on fibromyalgia over the past two decades, but I have never been as excited as I am right now. To be part of a study that has the potential to prove fibromyalgia as a disease with definite treatments is probably the pinnacle of my work.

Dr. Gillis Is Committed

About this announcement, Dr. Gillis told me, “We are hoping to finally bring our understanding of fibromyalgia out of the Dark Ages. Millions of women, men and children suffer from fibromyalgia, yet our understanding and acknowledgement of this as a legitimate medical condition is still so limited and has not advanced in a meaningful way in decades. With the clinical efforts being initiated as part of today’s announcement, we hope to finally change this and, ultimately, we are seeking to provide answers and better solutions for people who suffer from fibromyalgia.”

Follow @TheFMTest on Facebook

What is “Campaign 250?”

According to Epicgenetics, Campaign 250 represents the largest and most ambitious study to investigate fibromyalgia’s genetic origins, as well as develop a treatment protocol addressing the underlying biology of the disease.

Download PDF at
https://drive.google.com/file/d/0B6iFloW6MyVwakttOHFGUWpRNkk/view?usp=sharing


Under contract with researchers from both UCLA* and the University of Illinois College of Medicine Chicago, Campaign 250 will conduct Whole-Exome genetic testing on up to 250,000 patients who have received a positive FM/a® fibromyalgia diagnosis. All direct testing costs will be covered by EpicGenetics**. Based upon the findings of this testing and once treatment protocols have received regulatory and institutional approvals, FM/a® Test positive patients will be invited to participate in a fibromyalgia-specific vaccine clinical trial to reverse the biology of fibromyalgia. The vaccine trial will be conducted in cooperation with The Faustman Lab and Dr. Denise Faustman at the Massachusetts General Hospital/Harvard School of Medicine, the clinical trial will seek to alleviate fibromyalgia-related symptoms…

* The David Geffen School of Medicine at UCLA has been engaged to sequence the exomes of research subjects
**The genetic tests will require a $45 administration fee to cover the processing of the test, which is a $2,500+ cost being provided at no charge. 

Participation

I am anxious to see if I carry the fibromyalgia gene and I am honored to participate in providing information that can make a difference in the lives of people all over the world who live with fibromyalgia. I hope you can join me on this next chapter.




“The mighty oak was once a little nut that stood its ground.”
--Unknown


Additional Information:
FM/a® Blood Test – “How To” – My detailed account of the process


(Signature line appended July 2018)



In healing,

Celeste Cooper, RN / Author, Freelancer, Advocate

Think adversity?-See opportunity!



~ • ~ • ~ • ~ • ~ • ~

Learn more about Celeste’s books here. Subscribe to posts by using the information in the upper right hand corner or use the share buttons to share with others. 

Monday, June 27, 2016

The FM/a® Blood Test – "How To" and My Results


As many of you know last month  I wrote, Blood Test for Fibromyalgia: FM/a Test® Is Real, QA” for fibromyalgia awareness. My opinions for that article are based on research review and news articles surrounding the test.

As promised, I will now share with you my personal experience. 

My test results are in!


GETTING STARTED

Following are the steps I took.

·        I went to https://TheFibromyalgiaTest.com/ scrolled to the “click me” button in the “Ready to Get Started” area at the bottom of the page.
·        The next page - The FM/a®  Test must be authorized by a licensed physician. My rheumatologist ordered the test for me.

*Note: If you do not have a physician, please call 310-277-4600, M-F, 9am-5pm (PDT) and we'll help you find a fibromyalgia-friendly doctor at no charge. 

·        I printed the Physician’s Authorization Form, filled out what I could, and left it at my doctor's office for him to sign. My doctor's nurse, who is a peach, then faxed it to the number on the form.
·        Next, I answered "Yes" to 11 of the 12 questions. *You must be able to answer yes to at least four questions.
·        I filled out the Customer/Insurance Information Form.

DETAILED INSTRUCTIONS

Within a few days, I received a phone call from the coordinator letting me know my insurance provider authorized coverage (as are many). She answered all my questions and reassured me the test kit would include step-by-step instructions. (Something very important to those of us with fibrofog). 

Next:


·       The kit arrived within a few days, along with a prepaid Fed Ex bag.  


·        Paperwork included physician contact information, a medication list form, and a patient information sheet. (Because my rheumatologist was ordering the test, I was instructed to put the physicians signed order sheet in with the blood sample or to have my doctor’s office fax it to them, which in my case was already done.)

*Note: The medication form instructs, “Do not take the following drugs for 5 days prior to having your blood drawn, steroids, anti-cancer treatment drugs, or anti-rejection transplant drugs”.

·        I prearranged the Fed Ex pick up for the same day my blood was drawn.
·        Quite helpful is the specimen submission checklist because it has specific instructions on what to include with the specimen, handling and packaging of the tubes, Fed Ex copy, a contact number if you have questions, and the phone number for Fed Ex.
·        The specimen must be received within 24 hours after the blood is drawn.
·        DO NOT draw blood on Friday because "Overnight" express will not deliver until Monday, which the coordinator had told me during our phone conversation. 


I HADN'T THOUGHT OF THAT!

I hadn’t thought about all of the things that are included in the cost of the test.

·        Arranging for a phlebotomist to collect blood samples.
·        Pre-authorization with your insurance carrier.
·        Phone consultation regarding instructions and concerns.
·        Working with physicians, or finding a physician if necessary.
·        All supplies.
·        Expedited mailing.
·        A specialized lab for running the results. 
·        Dr. Gillis being personally available to patients to answer any questions. (That’s unheard of these days.)

MY RESULTS 

I mailed my specimen on a Wednesday, and the results took about a week.


FM/a®’s test results are based on a 1-100 scoring system; patients with active disease activity score 51 and above. (My personal information was purposefully covered.)
  
MY SCORE = 96
“FM/a® is a multi-biomarker-based test which concerns immune system white blood chemokine and cytokine patterns. Patients with fibromyalgia have a significantly dysregulated pattern regarding these proteins.”

The FM/a® test gives me concrete objective evidence that I can share with all those on my healthcare team. No more questioning that my symptoms are due to a biological problem.  If you have read Integrative Therapies for Fibromyalgia, Chronic Fatigue Syndrome and Myofascial Pain: The Mind-Body Connection,  you know how important it is that I make sure all my doctors include the report in my medical records. 

It is equally reassuring to know that I contributed to changing the way fibromyalgia is perceived.  

NOW WHAT?

After decades of literature review, maintaining a website and blog, contributing in the past as a fibromyalgia expert at Sharecare, and writing for ProHealth and Health Central, my work and my diagnosis are validated. Will I continue to follow my own advice for living with fibromyalgia and the overlapping conditions I experience? Yes, absolutely. The coping strategies we discuss in our books are paramount to emotional, mental, and spiritual healing for any chronic illness.

THE CONCLUSION IS THE BEGINNING

Pioneers are those who trudge forward among adversity. Because of Dr. Gillis, Dr. Wallace and the many devoted people involved in this endeavor, as Dr Kevin White said in his book, Breaking Thru the Fibrofog: Proof that


FIBROMYALGIA IS REAL!

With the FM/a Test® available to researchers, there leaves no margin for error in identifying study participants. And, like HIV and AIDS, one day the consequences of fibromyalgia will be arrested.

In healing and hope, yours truly, Celeste


Additional reading:






(Signature line appended July 2018)


In healing,

Celeste Cooper, RN / Author, Freelancer, Advocate

Think adversity?-See opportunity!



~ • ~ • ~ • ~ • ~ • ~

Learn more about Celeste’s books here. Subscribe to posts by using the information in the upper right hand corner or use the share buttons to share with others. 

Saturday, May 10, 2014

Making Our Way to May 12th: New reports - FIBROMYALGIA, a neuro-immune disorder, a biomarker, and the NFMCPA goes to bat by Celeste Cooper


http://TheseThree.com
Jan Chambers and Rae Marie Gleason (Medical Education & Research Director for the NFMCPA) met with the National Institute of Health (NIAMS) in Bethesda, Maryland on March 27, 2014. Ms. Gleason discussed the fact that "there is now the FM/a blood test developed by Dr. Bruce Gillis (EpicGenetics) . Ms. Gleason also informed the NIAMS group that a second FM/a scientific blood biomarker study was presented at the American College of Rheumatology (ACR) meeting this past October (2103), which has been submitted for publication. Ms. Gleason drew attention to the fact that "the FM/a blood test is also being used in an NIH funded study to differentiate fibromyalgia patients from control patients." (Here).

Jan Chambers, President of the National Fibromyalgia and Chronic Pain Association (NFMCPA), has shared her concern of having up to four fibromyalgia diagnostic criteria. She believes, and rightly so, that having the FM/a blood test will provide a differential diagnosis. In light of the different criteria that may be misunderstood by those diagnosing fibromyalgia having a biomarker is important. My concern has always been that when rheumatologists don't agree, how is the general practitioner going to decide which one to use. A huge thank you to Jan Chambers and Rae Gleason for also discussing this at the FDA Fibromyalgia Public Patient-Focused Meeting held on March 26, 2014. You can read more about the meeting here.

The"polysymptomatolgy" (many unexplained symptoms or "fibromyalgianess") in the Wolfe, et al. criteria (2010) has posed a problem for me. Understanding the comorbidities to FM helps the diagnostician, your physician, determine if your symptoms warrant further investigation beyond the primary symptoms of disordered sleep, fatigue, cognitive disturbance, and body-wide pain. Having a reliable biomarker will make certain that research is specifically targeting people with fibromyalgia in light of diagnostic criteria conundrum.

Dr. Robert Bennett has been a leading expert, clinician, and researcher regarding fibromyalgia for many decades, and he and others (2104) believed a study to validate the Wolfe, et al. 2011 criteria was in order. The ACR is paying attention and you can view the updated information here

Other studies, those on large and small polyfiber neuropathy from fibromyalgia skin biopsies, also suggest there is an immune factor involved. (Caro and Winter, 2014). I wondered about an immune connection at the time of the Albrecht, et al. study (2013). It is possible that our future could hold immune-globulin in our future, but more studies are necessary. One thing we can feel more comfortable about is that if study participants are screened with the FM/a test (93% accuracy) there will be no room for a guessing game.  

I believe there is a central reason for why certain diseases cluster with fibromyalgia. In light of the evidence presented here, and the effects they could have on the sympathetic nervous system, fibromyalgia could be reclassified as a neuro-immune disorder. 

My personal thoughts until otherwise contradicted is that fibromyalgia is not equal to centralization of pain. If this were true, every low back patient would also have some of the comorbid disorders of FM, which has not been evidenced. More research is needed, but the NIH is FINALLY headed in the right direction.

Showing my support

I have worked with Jan Chambers and the NFMCPA, including our shared participation in the PAINSproject. Jan is not a person to boast about what she and her organization do. So let me give you a sample.

Jan travels from coast to coast. In this past year, she attended the MYOPAIN conference, the Pain Action Alliance to Implement a National Strategy (PAINS) meeting in Washington DC, [You can read the report on my website here, the ACR meeting, the FDA meeting on Drugs and Treatments for fibromyalgia (twice, the first was canceled after she got there due to weather), and she met with the NIH. Not an easy feat for a fibromyalgia patient that headquarters in Utah. Jan sponsors awareness programs across the nation, she implemented the Leadership program for advocates, she has spoken to Utah legislators and has been instrumental in legislation to benefit Medicaid patients with fibromyalgia. She, through the NFMCPA, publishes Fibromyalgia & Chronic Pain LIFE magazine, a newsletter you can get directly delivered to your email, and she gives countless speeches to raise awareness. She not only speaks directly to patients through various forums, she also networks directly with physicians, fellow advocates, and other change agents. This is my shortlist. I am grateful to call her our friend and I encourage you to donate $12 to the NFMCPA, here, so she can continue the important work she does.

“Knowing is not enough, we must apply. Willing is not enough, we must do.”
-- Johann Wolfgang von Goethe

You can self-advocate by sharing the information presented here with your team of healthcare providers and your peers. You may have an underlying condition diagnosed that is treatable. In our current healthcare delivery model, it is imperative that we use our voice, not only for ourselves, but also for future generations. I have found over-and-over again, we don't know how far our voice reaches, but one thing is certain, if we don't speak—no one will listen.


Resources:

Albrecht PJ, Hou Q, Argoff CE, Storey JR, Wymer JP, Rice FL. Excessive Peptidergic Sensory Innervation of Cutaneous Arteriole-Venule Shunts (AVS) in the Palmar Glabrous Skin of Fibromyalgia Patients: Implications for Widespread Deep Tissue Pain and Fatigue. Pain Med. 2013 May 20. doi: 10.1111/pme.12139. [Epub ahead of print]

Behm FG, Gavin IM, Karpenko O, Lindgren V, Gaitonde S, Gashkoff PA, Gillis BS. Unique immunologic patterns in fibromyalgia. BMC Clin Pathol. 2012 Dec 17;12(1):25. doi: 10.1186/1472-6890-12-25.

Bennett R, Friend R, Marcus D, Bernstein C, Han BK, Yachoui R, Deodar A, Kaell A, Bonafede P, Chino A, Jones K. Criteria for the diagnosis of fibromyalgia: Validation of the modified 2010 preliminary ACR criteria and the development of alternative criteria. Arthritis Care Res (Hoboken). 2014 Feb 4. doi: 10.1002/acr.22301. [Epub ahead of print]
Read more here

Caro XJ, Winter EF. Evidence of abnormal epidermal nerve fiber density in fibromyalgia: Clinical and immunologic implications. Arthritis Rheumatol. 2014 Apr 9. doi: 10.1002/art.38662. [Epub ahead of print]

Fernandez-de-Las-Penas C, Penacoba-Puente C, Cigaran-Mendez M et al. Has catechol-O-methyltransferase genotype (Val158Met) an influence on endocrine, sympathetic nervous and humoral immune systems in women with fibromyalgia syndrome? Clin J Pain. 2014.30(3):199-204.

New Diagnostic Criteria Pinpoints Fibromyalgia CME by Diedtra Henderson, here.

Martínez-Martínez LA1, Mora T, Vargas A, Fuentes-Iniestra M, Martínez-Lavín M. Sympathetic nervous system dysfunction in fibromyalgia, chronic fatigue syndrome, irritable bowel syndrome, and interstitial cystitis: a review of case-control studies. J Clin Rheumatol. 2014 Apr;20(3):146-50.

Wolfe F, Brähler E, Hinz A, Häuser W..Fibromyalgia prevalence, somatic symptom reporting, and the dimensionality of polysymptomatic distress: Results from a survey of the general population. Arthritis Care Res (Hoboken) 2013 Feb 19. doi: 10.1002/acr.21931. [Epub ahead of print]

Wolfe F, Clauw DJ, Fitzcharles MA, Goldenberg DL, Häuser W, Katz RS, Mease P, Russell AS, Russell IJ, Winfield JB: Fibromyalgia Criteria and Severity Scales for Clinical and Epidemiological Studies: A Modification of the ACR Preliminary Diagnostic Criteria for Fibromyalgia. J Rheumatol. 2011 Jun;38(6):1113-22. doi: 10.3899/jrheum.100594. Epub 2011 Feb 1.

Wolfe F, Clauw DJ, Fitzcharles MA, Goldenberg DL, Katz RS, Mease P, Russell AS, Russell IJ, Winfield JB, Yunus MB. The American College of Rheumatology preliminary diagnostic criteria for fibromyalgia and measurement of symptom severity. Arthritis Care Res (Hoboken). 2010 May;62(5):600-10.

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All answers and blogs are based on the author's opinions and writing and are not meant to replace medical advice.  

Celeste Cooper is a retired RN, educator, fibromyalgia patient, and author of books related to chronic pain and illness. You can read more about Celeste and her work on her Amazon Author Profile, here , or look to the right of this blog for direct links to her work.

Celeste is a fibromyalgia expert for Dr. Oz, et al., at Sharecare.com, here, and she advocates for all chronic pain patients as a participant in the Pain Action Alliance to Implement a National Strategy, here. You can read more educational information and about her books on her website, http://TheseThree.com


Celeste's Website

Celeste's Website
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