TrueCardium® is developed and applied in alignment with emerging New Approach Methodology (NAM) frameworks increasingly referenced in global nonclinical regulatory evaluation. Data generated using TrueCardium® NAMs has been reviewed in regulatory contexts by BfArM (Germany) and the U.S. FDA as part of integrated nonclinical pharmacology packages supporting clinical translation.

TrueCardium® provides ready-to-use, physiologically advanced human cardiac organoids for immediate integration into preclinical research and drug development workflows. These vascularised and multicellular iPSC-derived heart organoids enable highly predictive cardiac safety testing, translational disease biology studies, and therapeutic evaluation in a human-relevant model. Available in both healthy and selected disease states, TrueCardium® organoids offer a scalable platform for pharmaceutical and biotechnology partners seeking reproducible, next-generation non-animal methods (NAMs) for cardiovascular research.

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. Using patient-relevant genetic and stress-induced perturbations, we generate advanced 3D human cardiac organoid models that capture complex pathophysiology beyond traditional 2D cultures or animal systems. These bespoke disease platforms support mechanistic discovery, target validation, and human-specific efficacy testing for next-generation therapeutic programs.

We provide comprehensive compound screening services in human cardiac organoids, enabling 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 translational screening solutions.

GENISYST® is Genome Biologics’ advanced platform for modeling complex disease heterogeneity within TrueCardium® organoids, enabling 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® captures the biological complexity underlying cardiovascular disease progression and variable drug response. This technology supports precision medicine applications, responder identification, and discovery of novel therapeutic targets in highly human-relevant cardiac systems.

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.

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.

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.

Screening, AI analytics, and biomarker discovery are essential components in the development of a cardiac organoid platform, which enhances cardiotoxicity testing and disease modeling.

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)

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

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)

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

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)

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

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).

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.

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.

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.
Regulatory programs including the U.S. FDA ISTAND initiative and the Comprehensive in vitro Proarrhythmia Assay (CiPA) paradigm reflect increasing integration of NAM-aligned evidence within nonclinical safety assessment.
TrueCardium® NAM data has been included in nonclinical evaluation packages submitted in regulatory contexts.
Learn more about the broader regulatory and evaluation context for cardiac NAM platforms at CardiacNAM.com.
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