CHARLOTTESVILLE, VA – March 26, 2024 – AMPEL BioSolutions announces a breakthrough in personalized precision medicine that will revolutionize the way doctors manage the autoimmune disease Lupus. Revealed in the peer-reviewed journal Genome Medicine and being made available to patients through a US follow-on study, the LuGENE® blood test forecasts patient flares and drug targets from gene expression utilizing predictive AI.
The LuGENE® lab test is now launching at several Lupus practices around the country including those in medical centers, concierge practices and healthcare systems as a practical decision support biomarker test that could greatly impact day-to-day healthcare for patients with Lupus. The blood test predicts flares before they happen and provides specific information about a patient's disease abnormalities leading to symptoms, allowing physicians to make evidence-based decisions regarding therapy including whether a patient is stable on their current therapeutic regimen. There are a million and a half lupus patients in the US that could benefit from LuGENE® by preventing unexpected flares and shortening the time to disease-controlling therapy.
From RNA gene expression in cells circulating in the blood, LuGENE® identifies real-time abnormalities leading to inflammation and immune system dysfunction that are targetable by medication. Some abnormalities are well-known and others are novel. Until now, therapeutic intervention is a trial-and-error endeavor that often takes years until a patient is stabilized without further threat of organ-damaging flares. LuGENE® clarifies that there are eight subgroups that make up the universe of Lupus patients, the reason why getting the right drug to the right patient at the right time has been so challenging, as until now physicians did not have a tool to know what drug targets are abnormal in their patient. AMPEL's approach pinpoints the patient subgroup(s) that express the target of one or both of the FDA-approved drugs for lupus, Benlysta and Anifrolumab, providing decision support for physicians to potentially shorten the time to effective therapy and potentially improve quality of life.
Diversity across ancestries is a hallmark of Lupus and the AMPEL R&D team included patients from all ethnicities to ensure that LuGENE® is predictive for all patients in the United States living with Lupus. This is especially important as Lupus emerges earlier and with greater severity in African-American, Asian, Native-American and Hispanic/Latinx communities shortening life-span.
Lupus has been called the “cruel mystery” because until now doctors have few objective metrics to assess whether their patient is stable with low risk of flare. Patients with Lupus experience inflammation and pain from their immune system attacking their own organs and tissues with the same vigor as fighting off an infection. Ninety-five percent of Lupus patients have experienced a flare in the last year. Symptoms including extreme fatigue and "brain fog” that impact daily activities, including work and family life, has led to Lupus being referred to as an "invisible disability". A Lupus Foundation of America survey found that fifty-five percent of patients with Lupus reported a complete or partial loss of their income because they no longer are able to work full time due to complications of lupus; one in three have been temporarily disabled by the disease, and one in four currently receive disability payments.
“AMPEL is an industry leader in lupus disease management, and we are excited to unveil our latest advancement in the field of precision medicine,” said Dr. Amrie Grammer, Co-Founder and President/CSO of AMPEL BioSolutions. “With so many patients experiencing a flare every year, and a high percentage of those cases so severe that they are hospitalized, this is a crucial tool in our fight against Lupus. With LuGENE®, healthcare providers will be able to stabilize lupus patients faster than ever before, minimize the occurrence of disruptive flares and hopefully transform Lupus to a chronic condition with increased quality of life.”
“Currently, there is no way to predict flares or determine which treatment is most appropriate for each patient, and in many instances it can take many years for some patients to find the most effective one to manage their disease,” said Dr. Peter Lipsky, Co-Founder and CEO/CMO of AMPEL BioSolutions. “Healthcare professionals can now know whether a flare in disease activity in imminent and if the disease is not controlled, LuGENE® can identify the specific targets of therapies that are more likely to provide relief. The LuGENE® blood test is a monitoring biomarker that provides essential information to support personalized management for each individual lupus patient.”
"As a clinician, I am tired of wasting my patients' valuable time and money by trying different therapies for their Lupus using the 'trial and error" methodology, which is our only option now," said Dr. Don Thomas, Rheumatologist at Arthritis & Pain Associates of Prince George's County in Maryland, author of the Lupus Encyclopedia & Former Chair Advisory council Lupus Foundation of America DC/MD/VA, "This approach to taking care of Lupus patients ends up causing so much misery as they deal with life-altering symptoms and complications when therapies do not work or cause them side effects. The dream of using personalized medicine to assist me in choosing therapies that have a greater chance of working, based on their endotype and actual immunologic abnormalities, is closer to becoming a reality with the LuGENE® blood test."
"Lupus is a very complicated disease that is pleomorphic in nature and very difficult to treat," said Dr. Daniel Wallace, author of Dubois SLE and The Lupus Book & Rheumatologist at Cedars-Sinai, UCLA, Wallace-Lee Center and BoD member of the Lupus Research Alliance affiliate Lupus Therapeutics and LupusLA, "The LuGENE® blood test is a novel and innovative approach that has the potential to revolutionize the way heterogenous Lupus patients are managed by identifying their genomic biomarker fingerprint and predict if the disease is stable (or not) and what drug targets are abnormal indicating therapeutic options to consider."
"I want to express my excitement to be one of the first practices to utilize the LuGENE® genomic biomarker test for Lupus," Dr. John Tesser, Arizona Arthritis and Rheumatology Associates, "to potentially manage patients more specifically by being informed if a patient is stable on their current medication or if particular drug targets are abnormal. AMPEL's Genomic Platform with RNA analytics and machine learning is highly unique and is poised to provide true personalized medicine for patients living with Lupus. I am most enthusiastic to participate in the LuGENE® study called ReLATE that will examine the relationship between standard clinical & lab parameters with prediction of flare & abnormal drug targets."
"The LuGENE® blood test is incredibly exciting as it represents an important advance towards achieving personalized medicine for Lupus patients by using novel technology of explainable predictve AI and analytics that group all known gene expression by drug target," Dr. Cindy Aranow, Feinstein Institute at Northwell Health. "A key part of the AMPEL Genomic approach is subsetting/endotyping patients by their RNA biomarker fingerprint that predict a patient's disease status and potential to flare. I am delighted to be one of practices that is launching LuGENE® through the ReLATE study."
“I am excited about the publication describing LuGENE® as a blood test that offers rheumatologists clinically relevant information in real-time predicted by AMPEL's explainable-AI powered RNA analytic platform, that should be highly informative about an individual lupus patient's status," Dr. Orrin Troum, The Doctors of Saint John's Medical Center, Providence Healthcare "This approach could provide a real advance in personalized medicine for Lupus patients. Additionally, I am thrilled to be one of the first practices participating in the LuGENE® study called ReLATE.whose clinical report I anticipate will help me tailor Lupus management."
During the interview with Scripps News Network, Dr. Grammer explains how there is currently no way to predict flares or determine which is the most appropriate treatment for an individual lupus patient. Identifying a therapeutic regimen that stabilizes a patient's disease course often takes several years of trial and error.
LuGENE® is currently available through the ReLATE study at Cedars-Sinai in LA and Arthritis & Osteoporosis Consultants of the Carolinas (AOCC) in Charlotte NC. The study is expanding to sites across the US including Arizona Arthritis & Rheumatology, Feinstein at Northwell Health, Mayo Clinic, Providence Healthcare, Rush in Chicago, Hospital for Special Surgery, Cleveland Clinic, Univ of Maryland, Yale, MetroHealth at Case Western Reserve, U Mass, Duke and others. Physicians and patients enrolled at these centers will experience how the LuGENE® blood test informs lupus patient management.
Kathleen Arntsen, Lupus and Allied Diseases Association (LADA) President & CEO, "For people struggling daily to live with complex autoimmune diseases like Lupus, what motivates us to face another day is the promise and progress of research that will improve our quality of life. Our community has eagerly awaited the development of more effective therapeutic approaches that can be tailored to each individual. This groundbreaking LuGENE® blood test has the potential to achieve this goal and transform patient care not only for lupus but for other autoimmune conditions."
Emmitt Thompson III, Male Lupus Warriors, "Being able to predict a flare before it happens and get on stabilizing medications for my Lupus is a game changer! As patient who ends up in the ER frequently with organ damaging autoimmunity, I am encouraged by the possibility of getting ahead of Lupus inflammation by monitoring with the LuGENE® blood test."
Deidre Gee Baptista and Kirsten Gee Maeda, GEE Twins for Lupus and Lupus Foundation of Northern California Board Members: “With two decades of experiencing the ups and downs of chronic Lupus, we are thrilled for a truly more personalized approach to managing and treating this chronic autoimmune disease. The LuGENE® blood test provides a much needed, personalized approach to reducing inflammation, pain and what are now 'unpredictable flares'. Families navigating their lupus journeys look forward to getting ahead of autoimmune organ damage by getting to an effective treatment more quickly, helping patient's lead productive lives.”
Jay Remley, Inaugural Google Cloud Global Dir & Vice-Chair Lupus Foundation NC, "Lupus is a complex autoimmune disease that is often mis-treated for years, causing pain and anxiety for people living with this lifelong condition. The LuGENE® blood test may address this critical care need. One of the most challenging times for a Lupus warrior is the time to establish an initial therapy. The second most difficult time is the 24x7 anxiety that a patient endures waiting for the inevitable next flare to arrive. LuGENE® will provide decision support to physicians re whether a patient is stable on the current drug regimen and specifics about what drug targets are abnormal right now, both of which are monumental breakthroughs for the Lupus community."
McKenna Bowes, Molecular Biology Student, "As an undergraduate student in the Sawalha lab at the Univ. of Pittsburgh (BS, May 2025) and an aspiring medical student, understanding the science behind LuGENE® makes it even more exciting! Even after almost five years of living with lupus, I still find that managing symptoms and trying different medications can be a frustrating and lengthy process. The ability of the LuGENE® blood test to predict flares and identify different lupus endotypes with the LuGENE® score offers a more personalized and targeted approach to my lupus care, ultimately alleviating some of these challenges for patients overall . I believe that this test can significantly improve the lives of those living with lupus.”
Sobia Saleem MA LMFT, Psychotherapist and Lupus Advocate, "I am beyond thrilled at the launch of the LuGENE®. As a Lupus patient 10+ years, a blood test that can both predict flares and help my medical team prescribe me targeted therapies that work best with my body is an unprecedented leap. One of my greatest struggles is that Lupus is unpredictable and can rob you of important moments decreasing quality of life due to volatility in disease activity. To understand a flare is approaching in addition to what pathways are abnormal would be life-changing! I have wasted literal years of my life in pain because the current model of lupus treatment is a trial-and-error approach. The LuGENE® blood test solves two of the most unknown variables in a patient's journey,"
Estela & Juana Mata, Looms For Lupus, “As advocates for those living with lupus, and as people who live with lupus, we are thrilled about the LuGENE® blood test. Innovative approaches and precision medicine are crucial new ways to predict flares and manage care. More than exciting scientific advancements, personalized precision medicine is our hope for reducing irreversible damage and complications from unexpcted flares. This LuGENE® personalized blood test represents a transformative impact on patient care, giving those living with lupus, and potentially others living with autoimmune conditions, the knowledge of what drug targets are abnormal so they can discuss early treatment opportunities with their doctors to potentially improve quality of life.”
Christine von Raesfeld, NIH All of Us Ambassador and People with Empathy Founder: "As a Lupus patient of mixed ancestry, I've experience long-term damage from standard treatments. I believe LuGENE® offers immense promise for our autoimmune community. By analyzing our gene expression profile, LuGENE® empowers patients to tailor their treatments, especially crucial for minority populations often underserved by current therapeutic approaches. Instead of "trial and error" prevalent in today's standard-of-care, LuGENE® provides a path to targeted treatment that minimizes flares and bridges the gap between science and personalized precision care."
AMPEL is a Precision Medicine 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 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 for target identification, pre-clinical models, post-hoc analysis and real-time enrichment during clinical trial enrollment. The company's portfolio of tests are supported by the AMPEL Genomic Platform of RNA analytic tools and explainable predictive AI.