The world's first fully quantitative, stain-free, computer-assisted tissue assessment system to assist in the speedy and accurate diagnosis of fibrosis and cancer

About

Genesis 200 hardware is the world's first quantitative, fully-automated, stain-free, multi-organ, 2D & 3D multiphoton imaging system. Together with the HistoHepa software, it is designed to aid preclinical studies as well as clinical trials for the drug development of Nonalcoholic Steatohepatitis (NASH) to generate an objective and highly accurate quantification. The AI-based digital pathology is able to fully measure the histologic features of Fibrosis, Inflammation, Ballooning and Steatosis (FIBS) in NASH and provide a better stratification and observations of trends even within clinical stages in a continuous scale measurement. This technology is especially important in providing granularity as there are currently no approve drug for NASH treatment.

Key Benefits

There are currently challenges with biopsy-based clinical trial endpoints in NASH. Namely, the endpoints are based on a discrete NAS scores (Non-alcoholic fatty liver disease activity score) and Fibrosis stages giving rise to Inter and Intra-observer variability by pathologists. This leads to a subjective and semi-quantitative assessment. Our proprietary, AI-powered algorithm based on Supervised Machine Learning is able to provide a fully quantitative, objective and repeatable data for continuous scale measurement of NASH disease progression and regression. Utilizing Second Harmonic Generation (SHG) and Two-Photon Excitation (TPE) signals, our AI-based digital pathology is able to conduct image processing using just one unstained biopsy slide to analyze and quantify clinically relevant tissue structures and cell morphology.

Applications

Our focus is on the accurate assessment of nonalcoholic steatohepatitis (NASH), a silent chronic liver disease that is linked to unhealthy lifestyles and metabolic syndromes. NASH faces a huge unmet medical need in our world today, and is expected to become the biggest cause of liver transplants by 2020. To-date, we are involved in about 40% of all NASH Phase 2 and Phase 3 clinical trials. Besides NASH, we are also involved in multiple clinical trials and clinical studies in cancer and other fibrosis related studies.

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