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INSPIRED BY PATIENTS DRIVEN BY DATA

Humanizing Drug Development with Growing Regulatory Confidence

INSPIRED BY PATIENTS DRIVEN BY DATA

Humanizing Drug Development with Growing Regulatory Confidence

Bridging translational evidence and regulatory confidence

Genome Biologics' TrueCardium® is a human cardiac organoid platform developed to advance Non-Animal Methods/New Approach Methodologies (NAMs) for cardiotoxicity testing, disease modelling, and translational efficacy assessment.

TrueCardium® platform-generated data have been reviewed by the German Federal Institute for Drugs and Medical Devices (BfArM) and the U.S. Food and Drug Administration (FDA) as part of an integrated nonclinical pharmacology package that included small-animal proof-of-concept studies and TrueCardium® human cardiac organoids. This body of evidence contributed to regulatory decision-making supporting clinical entry of a novel chemical entity.

Together with multiple peer-reviewed translational studies, these milestones highlight the maturity, reproducibility, and human relevance of the TrueCardium® platform and its potential to reshape how cardiac safety and efficacy are evaluated.

Our Services

Genome Biologics is a resident company of Johnson & Johnson Innovation - JLABS, a premier life science incubator program. JLABS is a global network of open innovation ecosystems, enabling and empowering innovators to create and accelerate the delivery of life-enhancing health and wellness solutions to patients around the world. As a leader in innovation, JLABS helps entrepreneurs in pharmaceutical, medical device, consumer, and health tech bring healthcare solutions to patients and consumers.

INSPIRED BY PATIENTS DRIVEN BY DATA

INSPIRED BY PATIENTS DRIVEN BY DATA

Bridging translational evidence and regulatory confidence

Transformative therapy discovery

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