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EpicGenetics Launches First Confirmatory Test for Condition That Affects Millions


6/12/2013 2:08:22 PM

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July 12, 2013 -- Fibromyalgia (FM) affects more than 12.3 million people in the United States, according to the American College of Rheumatology—nearly as many as cancer (12.5 million). Still, millions of FM sufferers are misdiagnosed each year or dismissed by their doctors with no hope of relief. Many are labeled neurotic, hypochondriacs, or simply chronic complainers because doctors fail to accurately diagnose them.

That has now changed. Today researchers know that fibromyalgia is an immune system dysregulation disease,[1] and the FM/a® test by EpicGenetics can provide an accurate diagnosis within one week through a simple blood test.

Whether it’s called fibrositis, chronic fatigue syndrome, fibromyositis or another name, fibromyalgia is an actual illness with numerous symptoms: diffuse, chronic pain, fatigue, memory loss, impaired cognition (often called “brain fog”), tenderness, insomnia, and depression. Symptoms are often aggravated by stress and environmental factors.

How the test works

Most FM patients spend an average of five painful years and thousands of dollars annually before they are accurately diagnosed. Until now, fibromyalgia patients were often stigmatized as having a “bogus” illness because they look perfectly healthy and there was no way to prove that they were sick. But for $744.00, the FM/a test can now tell you if you have fibromyalgia in a fraction of the time and for significantly less money.

The test looks at the body’s immune system and how it produces critical proteins called chemokines and cytokines. Patients with fibromyalgia have a significantly abnormal pattern regarding these proteins. The FM/a test results are based on a 1 to 100 scoring system: patients with fibromyalgia have scores of 50 and above.

The FM/a test is more than 95% sensitive, which is comparable to the accuracy of the HIV blood test and significantly more accurate than many commonly used tests for other medical conditions.

As someone who understands chronic pain and its effect on careers and families, it is heartening to know that others will not have to spend years being poked, prodded, frustrated, and often left depressed as they unsuccessfully seek diagnosis and effective treatment.

Recently I had an opportunity to talk with Dr. Bruce Gillis, CEO of EpicGenetics, about fibromyalgia and the new test. Dr. Gillis oversees two research programs, at the University of Illinois College of Medicine and the Harvard School of Public Health, and has a third in the works at the Weill Cornell School of Medicine in New York, which will study fibromyalgia in children.

SUMMERS: Fibromyalgia seems to run in my family, and the first time I heard any kind of diagnosis, it was Idiopathic Neuropathy.

DR GILLIS: I learned what the term 'idiopathic' meant when I was a young man in medical school.

SUMMERS: ‘I don’t know what’s wrong with me?’

DR. GILLIS: No. It means the doctor is an idiot and the patient is pathetic. But with the FM/a test, we now have something that objectively quantifies this medical problem.

SUMMERS: There was no real proof until now?

DR. GILLIS: Exactly. We spent three years getting to this point and we’ve confirmed that fibromyalgia is a real disease. Many people have similar symptoms. For example, a lot of people have depression. How do you know before you start taking that anti-depressant that you have depression versus fibromyalgia? We recommend you take the FM/a test. And we recommend that even though your doctor says, ‘You seem to fit all the criteria,’ it’s such a subjective conclusion and because of that, your spouse, your family, and your friends don’t really believe there is anything wrong with you.

Children and fibromyalgia

SUMMERS: You mentioned a study for children with fibromyalgia—I thought it was an adult disease.

DR. GILLIS: Well, what we’ve really been concerned about is how many children are being misdiagnosed with ADHD [attention-deficit hyperactivity disorder] when they might instead have fibromyalgia.

SUMMERS: My son was diagnosed with ADHD. And he’s very sensitive, emotional, and has physical aches and pains. DR. GILLIS: And think about that: when a child is given that diagnosis, it’s like a label that sticks with them for the rest of their lives. Instead, he could have fibromyalgia, and there is usually a genetic component. Moreover, if they are diagnosed with ADHD, we’re literally giving them a legal addiction to amphetamines.

SUMMERS: How are patients reacting to news that there is now a test?

DR. GILLIS: One of the big problems we’re having, interestingly, is that many people who have been diagnosed and are bitter because, as you said, they spend thousands upon thousands of dollars, and now for $744.00 you have something that’s definitive. You are no longer stigmatized because you have the objective FM/a test result. Now it’s ‘She has fibromyalgia,’ and not, ‘Uh, she’s irrational, crazy, neurotic, a hypochondriac, or hysterical.’

Getting the test

SUMMERS: What should patients know about getting the test?

DR. GILLIS: It has to be ordered by a doctor, and there are two ways to do that. You can have your doctor order the test by mailing or faxing us a prescription form. Or you can visit our website, thefmtest.com, and use one of our physicians (at no cost) to authorize the test.

To have one of our physicians order the test, you spend about a minute answering several questions and if you have a sufficient number of positive answers, our doctors can authorize the test. You then have three choices, all included in the price of the test: have your doctor draw your blood, go to one of 2,000 draw stations, or we can send a licensed phlebotomist to your home or work. We get your sample in 24 hours and most people get their test results in 5 to 7 days. It takes less than one ounce of blood.

Getting the right diagnosis saves money

SUMMERS: Are doctors generally aware of the test? Is it reimbursed by insurance?

DR. GILLIS: We just made it available six weeks ago, so it’s very new. Everyone who gets a test is also sent HCFA insurance forms, and we anticipate they will get at least some, if not all of the F/Ma reimbursed.

We’ve introduced it into the workers’ compensation insurance field and so far not one insurance company has refused to pay for it. Occasionally we’ve heard, ‘everybody’s going want the test,’ but the response is easy: You’re already spending an average $4,800 to $9,300 per patient per year to get a subjective diagnosis. Therefore, we are able to provide an objective test result for 98% less money.

SUMMERS: One of the big questions patients will ask is, will this lead to a cure?

DR. GILLIS: The only way you can ever find a cure is to know what is causing the medical problem. We have now made a breakthrough. We found the first piece of the puzzle. It is a very strong finding, but there is still a ways to go for a cure.

Educating the medical community

SUMMERS: What are you doing to inform the medical community?

DR. GILLIS: We have to educate the medical community about this major disease. Our first program was last month in Chicago, with Professor Earnest Brawn, the head of the rheumatology training program at UCLA, the number one rheumatology fellowship in the country. We invited physicians and nurse practitioners to the University of Illinois to train them about fibromyalgia, the FM/a test, and how to change their perspective regarding this medical disorder.

SUMMERS: How are you educating the patients?

DR. GILLIS: We’re creating another website called FibroAnswers, which will provide straightforward information for patients with fibromyalgia and chronic fatigue syndrome.

In our search to get involved with the fibromyalgia community, we found many websites disappointing because they were pushing memberships and products and not giving out accurate and/or up-to-date medical information to the fibromyalgia community.

That was the real surprise. So we decided to have our own website that will talk about the science and where we are going with the test and the research. We expect FibroAnswers.net to be operational very soon.

Current treatments

SUMMERS: How are these patients treated?

DR. GILLIS: This is the question I am always asked: ‘Alright, you’ve diagnosed me; now how do you treat me? How do you cure me?’

There are three FDA-approved drugs: Lyrica, Savella, and Cymbalta, (which will become a generic soon). To receive FDA approval, these manufacturers only had to show an improvement in patients by a factor of 15%. That is less than a placebo response. And I have been told by fibromyalgia sufferers that only about 30% benefit from these three drugs and rarely for more than 12-18 months. Therefore, we plan to incorporate genomic testing as part of the FM/a test so we might uncover the genetic markers for fibromyalgia. Such a discovery would be the fastest way to find a cure.

SUMMERS: It is sad to hear that existing treatments are so ineffective.

DR. GILLIS: Yes, so most of these people lead very limited lives. Keeping jobs and even moving around can be difficult. SUMMERS: Thank you very much for the work you have done for fibromyalgia patients. Is there anything else you would like readers to know?

Dr. GILLIS: Only that with this test, patients with early symptoms can now get the right diagnosis sooner and at less personal cost and start making lifestyle changes that may improve their long-term prognosis and help them to lead happier lives. Until a person undergoes the FM/a test, they can never achieve the peace of mind regarding why they are sick and finally prove to their doctors, spouses, family, friends and most importantly, themselves, that they are legitimately ill. Annette Summers is the founder of GeneCom Group, a marketing and public relations agency specializing in the Biomedical industry. She often writes editorial articles about medical and life science topics of interest. Email Annette, annette@genecom.net or visit genecom.net.

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