Bridging Translational Evidence with Regulatory Confidence
Genome Biologics offers cutting-edge human cardiac organoid screening services through its advanced NAM cardiac organoid platform, TrueCardium®. This multicellular platform is specifically designed to enhance predictive cardiotoxicity testing, facilitate disease modeling, and assess translational efficacy.
TrueCardium® has undergone evaluation in regulatory contexts by the German Federal Institute for Drugs and Medical Devices (BfArM) and the U.S. Food and Drug Administration (FDA) as part of comprehensive nonclinical pharmacology packages. These evaluations underscore TrueCardium®'s capability to produce human-relevant evidence that bolsters decision-making processes and aids in clinical translation.
In conjunction with numerous peer-reviewed translational studies, these achievements highlight the reproducibility, maturity, and human relevance of the TrueCardium® NAM platform, showcasing its potential to advance next-generation non-animal methods for cardiac safety and efficacy evaluation.
Accelerating Cardiovascular Drug Discovery for Partners
Genome Biologics supports pharmaceutical and biotechnology partners through drug discovery screening, therapeutic target validation, and efficacy testing using our advanced cardiac organoid platform featuring TrueCardium® NAM human cardiac organoids.
Our integrated service platform combines disease-relevant 3D cardiac biology with functional readouts and advanced analytics to accelerate the development of therapies for cardiovascular and cardiometabolic diseases. This is particularly crucial in areas where traditional 2D assays and animal models often fail to predict human outcomes.
We provide comprehensive study packages that include cardiotoxicity testing, custom disease modeling, mechanistic multi-omics profiling, and regulatory-ready reporting to help our partners de-risk their programs and advance safer, more effective treatments.
Advancing Cardiovascular Research with Human Organoids
TrueCardium® is a robust, human-relevant NAM cardiac organoid platform designed to model cardiac function, disease mechanisms, and drug responses in a physiologically advanced 3D system.
Its scalability, reproducibility, and predictive performance make TrueCardium® an essential tool for pharmaceutical and biotechnology partners seeking next-generation approaches to cardiovascular drug development, including:
- Early cardiotoxicity risk assessment and clinical de-risking
- Efficacy testing in human disease-relevant cardiac models
- Target validation and mechanism-of-action studies
- Identification of new therapeutic indications for existing compounds
- Non-Animal Methods / New Approach Methodologies (NAMs) supporting human-relevant safety and toxicity evaluation while reducing reliance on animal testing
TrueCardium® NAMs bridges the gap between simplified in vitro assays and clinical outcomes, enabling more predictive decision-making in cardiac safety pharmacology and translational research.
Genetic & Stress Induced Disease Modeling
Cardiotoxicity
Diabetic Cardiomyopathy / HFpEF
Diabetic Cardiomyopathy / HFpEF
Genome Biologics offers predictive cardiotoxicity testing and disease modeling services using our advanced cardiac organoid platform, TrueCardium® human cardiac organoids. This innovative approach allows for the evaluation of drug-induced cardiac injury and functional impairment. Our platform supports modeling of NCE-related toxicity, including anthracycline cardiotoxicity and kinase inhibitor liabilities, enabling the early identification of adverse cardiac risks that go beyond conventional 2D assays and animal studies. These human-relevant models provide scalable endpoints for cardiac safety pharmacology, regulatory-aligned NAM workflows, and translational de-risking in drug development.
Diabetic Cardiomyopathy / HFpEF
Diabetic Cardiomyopathy / HFpEF
Diabetic Cardiomyopathy / HFpEF
TrueCardium® enables advanced modeling of diabetic cardiomyopathy and HFpEF (heart failure with preserved ejection fraction) through metabolic and stress-induced perturbations that replicate human cardiometabolic dysfunction. These disease models utilize a cardiac organoid platform to capture lipid accumulation, oxidative stress, fibrosis, and impaired relaxation dynamics in a multicellular 3D system. Genome Biologics provides these HFpEF platforms for therapeutic target validation, efficacy testing, and cardiotoxicity testing, addressing one of the highest unmet-need areas in cardiovascular medicine.
Inflammation-Driven Remodeling
Diabetic Cardiomyopathy / HFpEF
Inflammation-Driven Remodeling
Genome Biologics develops a cutting-edge cardiac organoid platform that focuses on human cardiac organoid models of inflammation-driven remodeling. This platform enables mechanistic investigation of immune-triggered cardiac dysfunction and fibrosis. TrueCardium® supports modeling of cytokine exposure, endotoxin stress (e.g., LPS), and clonal hematopoiesis–associated inflammation (CHIP), effectively capturing the structural and functional remodeling processes that contribute to heart failure progression. These models are particularly valuable for cardiotoxicity testing and evaluating anti-inflammatory cardiovascular therapies, as they help identify human-specific pathways that are often overlooked in traditional animal systems, enhancing disease modeling efforts.
Ischemic Injury
Inflammation-Driven Remodeling
TrueCardium® ischemic injury models leverage a cardiac organoid platform to replicate hypoxia-induced myocardial damage and post-infarction remodeling in a physiologically relevant human environment. By simulating oxygen deprivation, reperfusion stress, and tissue injury responses, these models facilitate cardiotoxicity testing and the evaluation of cardioprotective compounds, regenerative strategies, and mechanisms of infarct-associated heart failure. Genome Biologics offers ischemia-relevant screening and mechanistic packages for partners focused on developing therapies targeting myocardial infarction and cardiac repair through advanced disease modeling.
Mitochondrial myopathies
Genome Biologics offers specialized TrueCardium® disease models for mitochondrial cardiomyopathies and metabolic energy-deficiency disorders, effectively utilizing our cardiac organoid platform to capture impaired oxidative phosphorylation, altered substrate utilization, and contractile dysfunction. These models are highly relevant for rare mitochondrial syndromes as well as broader cardiometabolic drug safety evaluation, including cardiotoxicity testing and mitochondrial toxicity screening. Our platform supports mechanistic discovery and therapeutic validation in human cardiac systems, where mitochondrial dysfunction is a primary driver of disease.
Rare Disease
TrueCardium® offers a robust cardiac organoid platform that facilitates the modeling of rare and orphan cardiovascular diseases using patient-specific or genetically engineered iPSC-derived cardiac organoids. Genome Biologics is dedicated to supporting the custom development of disease modeling for rare cardiomyopathy and congenital disease models, which are crucial for precision drug discovery, target validation, and cardiotoxicity testing. These human-relevant platforms provide a vital foundation for therapeutic development in diseases where clinical cohorts are limited and animal models frequently fail to accurately capture human pathophysiology.
TrueCardium® NAM Readouts
Cardiotoxicity Viability & Cell Injury
Mitochondrial Function & Metabolic Cardiotoxicity
Cardiac Contractility & Functional Performance
Assess compound-induced cytotoxicity and cardiac cell injury in TrueCardium® human organoids to identify early cardiotoxicity liabilities. These assays provide robust viability and biomarker-based safety endpoints for preclinical drug screening.
Endpoints
Cell viability: CellTiter-Glo®, Alamar Blue
Cell death & membrane integrity: LDH release
Cardiac injury biomarkers: hs-Troponin T (hsTnT)
Secreted stress reporters (custom panels)
Cardiac Contractility & Functional Performance
Mitochondrial Function & Metabolic Cardiotoxicity
Cardiac Contractility & Functional Performance
Measure beating strength, calcium handling, and functional impairment in human cardiac organoids to evaluate drug-induced contractile dysfunction, arrhythmia risk, and therapeutic efficacy.
Endpoints
Beating rate & force quantification
Calcium transient dynamics
Electromechanical coupling assays
Drug-response contractility profiling
Mitochondrial Function & Metabolic Cardiotoxicity
Mitochondrial Function & Metabolic Cardiotoxicity
Mitochondrial Function & Metabolic Cardiotoxicity
Profile metabolic flux and mitochondrial health in TrueCardium® organoids to detect energetic liabilities, oxidative stress, and cardiometabolic drug effects - critical for predicting human-relevant mitochondrial cardiotoxicity.
Endpoints
Seahorse metabolic flux (OCR/ECAR)
Oxygen consumption & hypoxia response
Lactate production assays
Mitochondrial membrane potential (JC-1/JC-10)
Cardiac Cell Cycle & Regenerative Responses
Multi-Omics Mechanistic Profiling & Target Discovery
Mitochondrial Function & Metabolic Cardiotoxicity
Quantify cardiomyocyte and stromal proliferation in human cardiac organoids to support regeneration studies, hypertrophy programs, and evaluation of growth-modulating therapeutics.
Endpoints
DNA synthesis assays: EdU incorporation
Proliferation markers: Ki-67
Mitotic activity: Phospho-Histone H3
Cell-cycle progression reporters
Senescence & Cardiac Aging Biomarkers
Multi-Omics Mechanistic Profiling & Target Discovery
Multi-Omics Mechanistic Profiling & Target Discovery
Detect cellular senescence and aging-associated stress pathways in TrueCardium® disease models, supporting drug development for heart failure, fibrosis, and age-driven cardiometabolic disease.
Endpoints
Senescence-associated β-galactosidase (SA-β-gal)
p16INK4a activation reporters
Inflammatory SASP profiling (optional add-on)
Multi-Omics Mechanistic Profiling & Target Discovery
Multi-Omics Mechanistic Profiling & Target Discovery
Multi-Omics Mechanistic Profiling & Target Discovery
Generate deep mechanistic insight from TrueCardium® screening studies through transcriptomics, proteomics, metabolomics, and spatial profiling - enabling biomarker discovery and regulatory-grade mechanism-of-action packages.
Endpoints
Bulk RNA-seq & single-cell RNA-seq
Spatial transcriptomics
Proteomics & phosphoproteomics
Metabolomics pathway mapping
Key Applications
Cardiotoxicity Screening
Disease Modeling & Mechanistic Studies
Disease Modeling & Mechanistic Studies
Genome Biologics provides highly predictive cardiotoxicity screening services using TrueCardium® human cardiac organoids to identify adverse cardiac liabilities early in drug development. Our platform enables functional and structural assessment of compound safety beyond traditional 2D cardiomyocytes or animal models, including viability, contractility, electrophysiology, and mitochondrial stress responses. TrueCardium® screening supports pharmaceutical and biotechnology partners in de-risking drug candidates, improving translational accuracy, and advancing next-generation cardiac safety pharmacology aligned with emerging non-animal testing strategies (NAMs).
Disease Modeling & Mechanistic Studies
Disease Modeling & Mechanistic Studies
Disease Modeling & Mechanistic Studies
TrueCardium® enables advanced human cardiac disease modeling and mechanistic investigation across cardiovascular and cardiometabolic indications, including HFpEF, fibrosis, inflammatory remodeling, and genetic cardiomyopathies. Our multicellular 3D organoid systems capture complex human pathophysiology that is often missed by animal models or simplified in vitro cultures. These disease models support therapeutic target validation, efficacy testing, and mechanistic pathway discovery, providing a scalable and human-relevant foundation for translational drug development and precision medicine research.
Personalized Medicine & Patient Stratification
Personalized Medicine & Patient Stratification
Personalized Medicine & Patient Stratification
Genome Biologics supports personalized cardiovascular medicine through patient-specific iPSC-derived TrueCardium® organoids that enable drug-response testing across diverse genetic and clinical backgrounds. By modeling inter-individual variability in cardiac physiology and disease susceptibility, our platform facilitates patient stratification, responder identification, and evaluation of precision therapeutics. These capabilities are particularly valuable for rare cardiomyopathies, heterogeneous heart failure syndromes, and translational programs requiring human-specific prediction of treatment outcomes.
Advanced Analytics
Personalized Medicine & Patient Stratification
Personalized Medicine & Patient Stratification
Our service offerings include integrated advanced analytics and multi-omics profiling to generate high-resolution mechanistic insight from TrueCardium® organoid studies. Genome Biologics combines functional readouts with transcriptomics, proteomics, metabolomics, and electrophysiology to deliver comprehensive datasets for target discovery and drug mechanism-of-action analysis. These end-to-end analytical packages support regulatory-ready reporting, biomarker identification, and AI-driven interpretation, enabling partners to accelerate decision-making in cardiovascular drug discovery and safety evaluation.
Services
Ready-to-use TrueCardium® organoids
Custom TrueCardium® disease modeling
Custom TrueCardium® disease modeling
TrueCardium® offers a cutting-edge cardiac organoid platform featuring ready-to-use, physiologically advanced human cardiac organoids that can be immediately integrated into preclinical research and drug development workflows. These vascularized and multicellular iPSC-derived heart organoids facilitate highly predictive cardiotoxicity testing, translational disease modeling studies, and therapeutic evaluation in a human-relevant model. Available in both healthy and selected disease states, TrueCardium® organoids provide a scalable solution for pharmaceutical and biotechnology partners looking for reproducible, next-generation non-animal methods (NAMs) for cardiovascular research.
Custom TrueCardium® disease modeling
Custom TrueCardium® disease modeling
Custom TrueCardium® disease modeling
Genome Biologics offers custom development of TrueCardium® disease models tailored to specific cardiovascular and cardiometabolic indications, including HFpEF, cardiac fibrosis, inflammation-driven remodeling, and rare genetic cardiomyopathies. By utilizing patient-relevant genetic and stress-induced perturbations, we create an advanced cardiac organoid platform that generates 3D human cardiac organoid models. These models effectively capture the complex pathophysiology that surpasses traditional 2D cultures or animal systems. Our bespoke disease modeling platforms support mechanistic discovery, target validation, and cardiotoxicity testing, ensuring human-specific efficacy testing for next-generation therapeutic programs.
Compound screening in TrueCardium® organoids
GENISYST®: Complex disease heterogeneity modeling
GENISYST®: Complex disease heterogeneity modeling
We provide comprehensive compound screening services using our advanced cardiac organoid platform, which enables early de-risking of cardiotoxicity and validation of therapeutic efficacy in a clinically relevant 3D heart model. TrueCardium® screening integrates functional readouts such as viability, contractility, electrophysiology, calcium handling, and metabolic profiling to assess drug responses across multiple cardiac cell types. Our service packages support both low- and medium-throughput workflows for pharma and biotech partners seeking predictive cardiac safety pharmacology and effective cardiotoxicity testing and translational disease modeling solutions.
GENISYST®: Complex disease heterogeneity modeling
GENISYST®: Complex disease heterogeneity modeling
GENISYST®: Complex disease heterogeneity modeling
GENISYST® is Genome Biologics’ advanced cardiac organoid platform designed for modeling complex disease heterogeneity within TrueCardium® organoids. This platform enables multiplexed analysis of genetic drivers, inflammatory pathways, and patient-stratified phenotypes. By integrating multi-cell-type interactions, multi-omics profiling, and AI-supported clustering approaches, GENISYST® effectively captures the biological complexity underlying cardiovascular disease progression and variable drug response, making it an essential tool for cardiotoxicity testing. This innovative technology supports precision medicine applications, responder identification, and the discovery of novel therapeutic targets in highly human-relevant cardiac systems.
Service Packages
Package 1: Cardiac Liability Screen
Package 2: Regulatory-Grade Cardiotoxicity Package
Package 2: Regulatory-Grade Cardiotoxicity Package
Viability and contractility assessments are crucial in our cardiac organoid platform, especially during the early de-risking panel for cardiotoxicity testing. We utilize IC50 measurements along with benchmark controls for effective disease modeling.
Package 2: Regulatory-Grade Cardiotoxicity Package
Package 2: Regulatory-Grade Cardiotoxicity Package
Package 2: Regulatory-Grade Cardiotoxicity Package
Our cardiac organoid platform utilizes a multi-dose, GLP-like structure, integrating transcriptomics and histology for comprehensive cardiotoxicity testing and disease modeling. This ensures FDA/EMA/BfArM-ready reporting.
Package 3: Disease Model Efficacy Study
Package 3: Disease Model Efficacy Study
Package 3: Disease Model Efficacy Study
HFpEF / Fibrosis / CHIP inflammation mechanisms and responder stratification are essential for advancing our understanding of cardiotoxicity testing. Utilizing a cardiac organoid platform enhances disease modeling, allowing for more precise insights into these complex conditions.
Package 4: Custom Discovery Partnership
Package 3: Disease Model Efficacy Study
Package 3: Disease Model Efficacy Study
Screening, AI analytics, and biomarker discovery are essential components in the development of a cardiac organoid platform, which enhances cardiotoxicity testing and disease modeling.
Publications
1. Targeting miRNA-1a and miRNA-15b: A Novel Combinatorial Strategy to Drive Adult Cardiac Regeneration using a cardiac organoid platform. Adv Sci (Weinh), e2414455 (2025).
2. Human heart organoids reveal a regenerative strategy for mitochondrial disease modeling. bioRxiv, 2025.2012.2018.695153 (2025).
3. Aging impairs the neurovascular interface in the heart, impacting cardiotoxicity testing. Science (New York, N.Y 381, 897-906 (2023).
4. The lncRNA Sweetheart regulates compensatory cardiac hypertrophy after myocardial injury in murine males. Nature Communications 14, 7024 (2023).
5. The endothelial-enriched lncRNA LINC00607 mediates angiogenic function. Basic Research in Cardiology 118, 5 (2023).
6. A human cell atlas of the pressure-induced hypertrophic heart supports advancements in cardiotoxicity testing. Nature Cardiovascular Research 1, 174-185 (2022).
7. Novel SARS-CoV-2 variants induce higher toxicity in cardiovascular cells, highlighting the need for effective disease modeling. European Heart Journal 42 (2021).
8. Mitochondrial–cell cycle cross-talk drives endoreplication in heart disease, relevant for cardiotoxicity testing. Science Translational Medicine 13 (2021).
9. Dissection of heterocellular cross-talk in vascularized cardiac tissue mimetics enhances our understanding of disease modeling. Journal of Molecular and Cellular Cardiology 138, 269-282 (2020).
10. SARS-CoV-2 infects and induces cytotoxic effects in human cardiomyocytes, underscoring the importance of cardiotoxicity testing. Cardiovascular Research 116, 2207-2215 (2020).