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AMPEL BioSolutions Announces Gene-Based Lupus Diagnostic

Monday, January 20, 2020  
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AMPEL BioSolutions' Co-Founder and COO/CSO and Virginia Bio Board Member, Dr. Amrie Grammer announced the kickoff of a Series A $12.5M raise to commercialize LuGENETM, a gene-based diagnostic at the Biotech Showcase at JP Morgan Healthcare week. AMPEL's initial focus is Lupus, but the test can be used for many autoimmune or inflammatory diseases. AMPEL'S goal is to have its test available for routine use by physicians within the next few years.

LuGENETM is a breakthrough in precision and personalized medicine that could revolutionize the way doctors treat chronic diseases, like Lupus. The lab test, only a concept for the last few years, is now ready for commercialization for practical decision support for precise drug treatment based on a patient's genes. LuGENETM will transform the way doctors treat chronic diseases by using the information gathered by the lab test and analyzed by machine learning to predict a flare and treat it before it even begins, saving patients from pain and inconvenience of a disease that otherwise drastically affects their lives.

"Predicting lupus disease flares, allowing initiation or modification of disease-modifying therapies, should have an important impact on patient health," stated Mary K. Crow, MD the Physician-in-Chief, Hospital for Special Surgery, Weill Cornell Medical Center and Former President American College of Rheumatology. "LuGENE seems to be an important step in that direction. Application of knowledge of molecular mechanisms to aid in patient management is the future of lupus care and will benefit patients and improve outcomes."

AMPEL's innovative gene-based approach has been reported in top tier peer-reviewed journals and utilizes proprietary bioinformatic tools and machine learning approaches. LuGENETM is now ready to be developed as a decision support CLIA-certified blood test that will greatly impact health care by allowing physicians to identify the cause of patient disease symptoms and select appropriate treatment precisely.

"Unpredictable flares can be a daily battle for many patients with lupus and other autoimmune conditions," says Deidre Baptista and Kirsten Maeda, "GEE Twins for Lupus", Lupus Foundation of Northern California (LFNC) Board Members. "From personal experience, we know flares come and go without warning and make it challenging for patients. AMPEL's promising breakthrough of their LuGENETM diagnostic is the news patients have desperately been waiting to hear. We applaud AMPEL BioSolutions's goal to help identify patients' disease activity in real time. The future of precision personalized medicine is getting closer with big data, technology, and genomic testing. It will certainly be a win-win not only for the patients but also the autoimmunity community. It's about time that advances will improve patient outcomes, reduce organ damage and save lives. Patients can't wait another 60 years for new treatment.

Currently, AMPEL uses its' proprietary approach to assist Pharma in patient enrichment during clinical trial enrollment, thus maximizing success by enrolling patients into trials that express the drug-targeted pathway. Pharmaceutical companies test drugs in clinical trials and face the challenge of enrolling patients that have the best potential to respond to the treatment being tested. Enrolling the "wrong" patients can result in trial failure, often leading to cancellation of a drug's development towards FDA approval that may have benefit in a sub-group of the overall patient population. AMPEL's blood test will help pharmaceutical companies identify which patients are most likely to respond to the tested treatment.

"Lupus care will greatly benefit from more precise evaluation of patients. LuGENE seems to be an important step in that direction. Patients would greatly benefit from a better way to relate their symptoms to immune abnormalities." Daniel J Wallace MD FACP, MACR, Professor of Medicine, Cedars-Sinai Medical Center David Geffen School of Medicine Center at UCLA in affiliation with AttuneHealth.

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