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AMPEL BioSolutions’ Breakthrough Predicts Drug Options for Fibromyalgia

AMPEL BioSolutions announced a breakthrough in precision and personalized medicine that could revolutionize the way doctors treat chronic pain syndromes, such as fibromyalgia. Revealed in the peer-reviewed journal Lupus Science and Medicine, the paper details AMPEL’s breakthrough approach to characterize the underlying disease activity from gene expression data obtained from patient blood samples.

The FibroGENE® lab test, only a concept for the last few years, is now ready for development for practical use as a decision support biomarker test that could greatly impact health care by allowing physicians to identify the cause of patient disease symptoms and select appropriate treatment more precisely.  AMPEL’s initial focus is fibromyalgia that affects Lupus patients, but the test can be used for millions of Americans diagnosed with fibromyalgia every year.

Working with colleagues at Duke University Medical Center, AMPEL found unique gene signatures that identified patients with Lupus who had prominent features of fibromyalgia. These signatures served as the basis of FibroGENE®, capable of identifying subjects with fibromyalgia with or without Lupus.

Fibromyalgia has been called the “invisible disability” because doctors have few objective metrics to assess disease status.  Patients with fibromyalgia experience pain in soft tissues, such as muscles and joints, that is not associated with inflammation.  Other common symptoms are extreme fatigue and “brain fog” that impact daily activities, including work and family life.  Johns Hopkins and the American College of Rheumatology estimate that fibromyalgia affects 3-4% of the US population (10-12 million people) with more than 25-35% receiving disability benefits.  The Hospital for Special Surgery in NYC estimates that 25% of all Lupus patients experience fibromyalgia.

Paired with AMPEL’s pipeline of tools to analyze very large and complex clinical datasets (“Big Data”), FibroGENE® is a significant step towards implementing a routine test for monitoring fibromyalgia and providing decision support for treatment based on a patient’s gene expression. This will transform the way doctors treat fibromyalgia by using the information gathered by the lab test and analyzed by bioinformatics to characterize the precise molecular abnormalities and treat symptoms, reduce pain and increase the quality of life of millions of Americans.  The application of AMPEL’s genomic approach to fibromyalgia could also assist pharmaceutical companies in drug development and clinical trials.  Importantly, FDA-approved drugs that target B cells, calcium channels and mitochondrial reactive oxygen species are candidates for therapy.

“A genomic platform to identify biomarkers for pain and fatigue in patients with Systemic Lupus Erythematosus represents an important step forward for these patients, and could help guide appropriate therapies,” said Dr. David Pisetsky, Rheumatologist, Professor of Medicine at Duke University School of Medicine and one of the co-authors of a paper publishing in Lupus Science & Medicine.

“I am excited to announce FibroGENE®, AMPEL’s latest precision medicine blood test that will not only help Lupus patients with fibromyalgia-like symptoms but also the estimated 10 million fibromyalgia patients who experience this disabling condition,” said Dr. Peter Lipsky, AMPEL Co-Founder, CEO and Chief Medical Officer. “AMPEL’s collaboration with Duke beginning in 2019 has generated a novel tool in our arsenal to assess patients more effectively and provide decision support for medications that may be the basis for precision medicine of affected patients and help improve their quality of life.”

“Lupus care will greatly benefit from more precise evaluation of patients.  AMPEL’s work solidifies the hypothesis that Lupus is driven by both type 1 inflammation and type 2 fibromyalgia-like components,” said Dr. Dan Wallace, Rheumatologist, Board of Governors, Cedars-Sinai Medical Ctr and UCLA, “and represents an important breakthrough by establishing an immune relationship between their characteristics which may lead to more precise treatment of patients.”

“FibroGENE® is an important breakthrough because the blood test will give doctors a more concrete way to communicate to patients the validity of their symptoms and suggest new therapeutic approaches,” said Dr. Peggy Crow, Rheumatologist, Director of the Autoimmunity & Inflammation Program at the Hospital for Special Surgery, Professor of Medicine and Immunology at Weill Cornell Medical School, NYC.

“As a lupus patient who suffers from chronic pain, learning that AMPEL is developing a lab test that will help my doctors identify what’s causing me pain and precisely target that in my treatment is nothing short of miraculous!” said Sobia Saleem, MA AMFT, Lupus Patient, Psychotherapist and LFNC Board Member, “One of the most difficult and exhausting parts of having autoimmune conditions is that doctors never exactly know what medication will work for my body. Much of the work we do in trying to figure out my treatment is trial and error. AMPEL’s FibroGENE® is a game changer that will save us pain and our bodies unnecessary drugs and chemicals. The right drug for the right person at the right time seems like the way of the future for patients and doctors alike!”

Angel Williams, Lupus Patient and Lupus Foundation of America DC/MD/VA Ambassador said, “FibroGENE® will change the face of how those living with both fibromyalgia and lupus look at being sick. We don’t care what we are taking meds for, we just want them for the right disease. FibroGENE gives us this!!!!!”

Juana Mata, Patient with Lupus and Fibromyalgia, NIH All of Us Ambassador and Looms for Lupus Founder, “FibroGENE® gives Lupus patients with Fibromyalgia-like symptoms hope as we face many challenges with severe pain and fatigue.  Understanding that doctors will have a blood test to pinpoint what is causing symptoms gives us hope in having a better quality of life early in our diagnosis or when we are having a flare.  Personalized precision medicine through blood testing is something we as patients are yearning for as we are all different and we experience different symptoms and need individualized treatment.”

Christine von Raesfeld, Patient with Lupus and Fibromyalgia, NIH All of Us Ambassador and People with Empathy Founder said, “With overlapping conditions and a multitude of symptoms, finding individualized treatments for patients with fibromyalgia and lupus has been difficult.  Having a personalized treatment plan is essential to mitigate symptoms and improve a patient’s day-to-day experience.”

“Our team has developed a tool that can conceivably transform the way patients with Lupus and Fibromyalgia conditions are treated” said Dr. Amrie Grammer, AMPEL Co-Founder, President and Chief Scientific Officer. “AMPEL is changing the paradigm of treatment in autoimmune and inflammatory diseases.  We are proud to be doing this work in Virginia and will continue to recruit talent and grow our business here.”

AMPEL BioSolutions is a precision medicine company commercializing a development pipeline of CLIA-certified gene expression tests for blood or tissue samples that provide clinical decision support by determining disease status, identifying molecular pathway and predicting drug options.  AMPEL’s technology is a cloud-based platform that hosts proprietary DNA/RNA analytic tools and machine learning algorithms covered by 25+ filed/pending patents and 90+ peer-reviewed publications. Disease areas for AMPEL’s precision medicine test portfolio include Systemic Lupus Erythematosus, Psoriasis, Scleroderma, Atopic Dermatitis, Lupus Nephritis, Cardiovascular, Sjogren’s Syndrome, ASD, Wellness, Lung Cancer and SARS-Cov2. AMPEL’s platform technology covers over 95% of all known genes and AMPEL’s exclusive curated database of >20,000 individual gene expression profiles with rich clinical information fuels machine learning predictions based on evidence. AMPEL BioSolutions was elected to the Coalition for 21st Century Precision Medicine in early 2022.

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