WHAT IS LuGENE®️

AMPEL is currently completing development and beginning commercialization of LuGENE®️.  The Laboratory Developed Test (LDT) to be completed and CLIA validated is a breakthrough analytic that provides a snapshot of a person’s immune system and can be used to support a physician’s evaluation of an individual patient for true personalized, precision medicine.

Using AMPEL’s unique pipeline of technical methodologies and proprietary machine learning informed predictive analytics, LuGENE®️ will generate a full gene expression profile from a blood sample and produce an integrated report for the physician on the status of all the cells of the immune system of an individual lupus patient. As an LDT, CLIA certification, but not FDA approval is required for commercialization.

Initially, LuGENE®️ will assist physicians with management and therapy selection for lupus, a complex, costly, difficult to diagnose and life-threatening autoimmune disease.  The technology platform for LuGENE®️ can be efficiently extended to develop diagnostics for other autoimmune, inflammatory and infectious diseases.

AMPEL’s LuGENE®️ Analytics and Genomic Fingerprinting tools for genomic profiling are already in use, generating revenue from leading pharmaceutical/biotech companies focused on determining suitability of a drug for development and enrichment of patients for a specific clinical trial. This provides LuGENE®️ competitive advantages, further builds our world leading proprietary database of lupus patients, provides access to high-volume patient practices and medical centers and validates our technology for more rapid adoption with a focused healthcare provider go-to-market strategy.

To learn more about this breakthrough technology please contact Dr. Amrie Grammer at amrie.grammer@ampelbiosolutions.com

AMPEL EXPERTISE

  • Autoimmunity
  • Immunogenicity
  • Immunology
  • Inflammation
  • Innate and Adaptive Immunity
  • Systemic Lupus Erythematosus
  • Lupus Nephritis
  • Rheumatoid Arthritis
  • Rheumatic Autoimmune/Inflammatory
    Diseases (RAIDs)
  • Drug Repositioning
  • Clinical Design and Management
  • Biomarker Discovery
  • Bioinformatics