CHARLOTTESVILLE, Va., October 8, 2024 -- AMPEL BioSolutions announced a precision medicine blood test that could save lives by predicting heart disease before it happens and providing decision support for prophylactic therapies. Inflammatory and immune system abnormalities identified in the blood of individuals predisposed to heart disease by AMPEL two years ago were confirmed and extended in the peer-reviewed Cell iScience paper announced today. Examination of genes expressed in single cells isolated from atherosclerotic coronary artery plaques revealed biomarkers that can be measured by AMPEL's CardioGENE® blood test.
AMPEL’s innovative approach linking genetic predisposition to real-time molecular pathways targeted by drugs may greatly impact health care by allowing physicians to identify cardiovascular disease risk and select appropriate therapeutic interventions. Importantly, today's publication demonstrated that common genetic risk factors driving cardiovascular disease in non-autoimmune individuals are the same as those from patients with a variety of autoimmune inflammatory diseases such as Lupus, Psoriasis, Type 1 Diabetes, Rheumatoid Arthritis, Primary Bilary Cirrhosis and Celiac Disease that all are at high risk for morbidity from cardiovascular events.
AMPEL's work extends the Cardiologist-driven Lancet study published last year demonstrating that inflammation as assessed by standard-of-care testing such as CRP or ESR predicts cardiovascular risk in individuals even after lipids were reduced to normal range with medication. AMPEL's work is the first time cardiovascular genetic risk factors have been identified in immune and inflammatory system genes expressed across autoimmune diseases even when a patient does not smoke, have elevated cholesterol or high blood pressure. AMPEL's CardioGENE® blood test is ready for development for practical use as a decision support biomarker test.
This innovation confirms AMPEL’s expansion into genetic testing as a second platform technology in addition to the work it already conducts in the field of RNA analytics and explainable predictive AI. By identifying the molecular pathways, CardioGENE® will allow health care professionals to prevent serious cardiovascular events with prophylactic targeted treatment. Importantly, FDA-approved drugs such as colchicine as well as biologics targeting inflammatory cytokines and immune cells are candidates for prophylactic therapy.
“The CardioGENE® blood test identifies inherited genetic markers in blood samples that drive pathways, which can be targeted by drugs,” said Dr. Amrie Grammer, AMPEL Co-Founder, President and Chief Scientific Officer. “We are confident that CardioGENE® will make a difference in the lives of all Americans especially those with autoimmune inflammatory diseases who disproportionately suffer from the disease’s cardiovascular impacts.”
"AMPEL is working hard to identify what is going on currently under the surface in the individual patient with specific predictions of inflammation as well as druggable targets that are abnormal," said Dr. Rob Sperling MD FACC, Cardiovascular Associates of Marin & San Francisco. "The identification of genetic and molecular inflammatory pathways involved in coronary artery disease especially in those without traditional risk factors is a game-changer and would allow the practice of true precision medicine where physicians are able to identify current active coronary disease as well as future risk of active coronary disease with actionable insights accelerating of new targeted therapeutics to prevent cardiac events. This next level, precision medicine, is what we need as clinicians and patients in the fight against coronary artery/cardiac pathology. Current predictive models are based on population studies and are not very good at the assessing the personal risk of the patient in front of us."
“Accelerated and prevalent atherosclerotic cardiovascular disease (CAD) in autoimmune patients is not explained by traditional risk factors,” said Dr. Jane Salmon, Co-Director Mary Kirkland Ctr for Lupus Research, Collette Kean Research Chair and Professor of Medicine at HSS and Cornell Weill, “AMPEL's discovery of genetically driven druggable pathways shared by autoimmunity and CAD provides a mechanistic basis for the well-established clinical associations between these conditions. Finding a common target to treat SLE along with the risk for accelerated CAD is very exciting. In addition, the subsets of genes identified may help to stratify risk for CAD in all patients."
"AMPEL's groundbreaking CardioGENE® blood test represents a significant leap forward in our fight against the devastating cardiovascular complications of lupus," said Tom Bakewell, Executive Director, Lupus Foundation of Northern California, "By enabling early detection of heart disease risk in lupus patients, we now have the potential to save countless lives. This precision medicine approach aligns perfectly with our mission to improve the quality of life for those affected by lupus. We're excited about the possibility of proactive, targeted interventions that this test could facilitate, potentially reducing the alarming incidents of cardiovascular-related fatalities in our lupus community."
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"This study confirms AMPEL's previous observations from blood that non-autoimmune individuals and those living with Lupus share genetic risk factors that drive gene expression leading to druggable inflammatory pathways," said Dr. Peggy Crow, Physician-in-Chief Emeritus HSS & Co-Director Kirkland Ctr for Lupus Res Cornell-Weill, "Importantly, AMPEL's application of single-cell RNASeq analysis of cardiac plaque tissue confirmed finding from the blood, including inflammatory macrophages and endothelial cells. AMPEL's approach suggests that peripheral blood can be used as a monitoring biomarker to predict risk and potential therapeutic interventions before cardiovascular symptoms in both autoimmune and non-autoimmune individuals."
“This peer-reveiwed publication not only contributes to our understanding of the genetic basis of the increased frequency of cardiovascular events in patients living with lupus, psoriasis and other autoimmune/inflammatory diseases, but also provides practical information on new molecular pathways contributing to atherosclerotic cardiovascular disease,” said Dr. Peter Lipsky, AMPEL Co-Founder, CEO and Chief Medical Officer.https://ampelbiosolutions.com/executive-team/ “We believe these findings will usher in new approaches to ameliorate one of the leading causes of death in those living with autoimmune disease, but also provide insights into mechanisms of atherosclerosis in at risk people in the general population.”
MEDIA CONTACT: Dr. Amrie Grammer, AMPEL Co-Founder, President and CSO, Cell: 240-401-8889, Email:This email address is being protected from spambots. You need JavaScript enabled to view it.
AMPEL is a Precision Health company commercializing a development pipeline of blood tests that measure dynamic RNA gene expression providing a real-time CLIA-certified report of inflammation status including drugs targets that are abnormal. Unlike DNA tests which only need to be done once, AMPEL's RNA blood or biopsy tests are utilized on demand with the goal of "treat to target" and optimal disease management re forecast flares for Lupus (LuGENE®) or Dermatology Conditions such as Psoriasis or Ezcema (DermaGENE®). For an otherwise healthy individual, AMPEL's prediction of inflammation with WellGENE® may be an early indicator of changes in the immune system that may be worth investigating further by a trained healthcare provider. In addition, AMPEL works with Pharma/Biotech customers as a CRO designing & operationalizing clinical trials as well as a biomarker partner for target identification, pre-clinical models, post-hoc analysis and real-time enrichment during clinical trial enrollment across a variety of therapeutic areas including cardiology, lung cancer, neurology and autoimmune disease. The company's portfolio of tests are supported by the AMPEL Genomic Platform of RNA analytic tools and explainable predictive AI.