MetaHeps Technology
The MetaHeps assay is a breakthrough tool to help you meet the regulatory to diagnose iDILI.
The MetaHeps assay
Personalized DILI causality assay
MetaHeps cells are derived from monocytes taken from individual patients with suspected DILI, carrying the genetic makeup and immunogenicity of the donor (e.g., HLA haplotype).
Identifies DILI-causing agents in co-medication
The MetaHeps assay identifies DILI-causing agents among co-medications by observing increased cytotoxicity in MetaHeps cells upon in vitro rechallenge with the DILI-inducing agent, but not with other co-medications.
The method distinguishes between DILI and non-DILI patients and can identify potential drug-drug interaction-caused DILI through in vitro re-challenges with combinations of suspected and unsuspected agents
The MetaHeps® DILI Causality Assay
Rechallenge test with the perpetrator drug in MetaHeps from DILI-suspected patients and non-DILI donors. Increased LDH release in comparison to respective controls, indicates the in vivo active perpetrator drug. All drugs from co-medication will be tested individually.
Blood sample
30-50mL of fresh blood sample or frozen PBMCs from patients
MetaHeps differentiation
Cells with donor specific characteristics
12-14 days
Re-challenge
Culture is exposed
to all potential
perpetrator drugs and combinations thereof
2 days
LDH release
Determination of LDH in supernatants and lysed samples
1 day
Data Analysis
Database of values across DILI, non-DILI controls, and normal healthy volunteer samples
1 day
Assessment of iDILI using different cellular systems
Assay features
Immortalized
human liver cells
MetaHeps
2D human hepatocytes
3D human liver spheroids
iPS - derived human hepatocytes
MetaHeps
Drug transport activity
LOW
INTERMEDIATE
INTERMEDIATE
LOW
LOW
Drug metabolism
LOW
INTERMEDIATE
INTERMEDIATE
LOW
LOW
Innate immune system features
LOW
HIGH
Genetic makeup
of the patient
HIGH
Immunogenicity of the patient
HIGH
Correlation with
clinical results
LOW
LOW
HIGH
Assay Sensitivity
LOW
LOW
N/D
N/D
HIGH
General availability
LOW
HIGH
HIGH
HIGH
LOW
Why we are the best solution
MetaHeps is the only experimental patient-specific DILI causality test for DILI adjudication in clinical trials
Unrivaled technology
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TransHeps is the only MetaHeps provider worldwide (exclusive license by UZH).
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About 4x faster as DILI Expert Adjudication (only 2-3 weeks vs. 2-3 months).
Valuable drug development tool
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Envisioned as a useful decision-making tool for drug developers and health authorities.
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Identifies or excludes DILI causative agents, particularly in cases of poly-medication.
Benefit for patients
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Reduces the need for invasive liver biopsy and the risk of drug rechallenge in clinical trials.
Improved assay performance and precision
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Accurate, reliable, consistent, and easily implementable in clinical trials
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Provides solid data quality with robust, reproducible results
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Has high sensitivity (92%) and specificity (100%)
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Qualification being persued by the TransBioLine Consortium (academia and industrial partner)
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Ongoing endorsement by the FDA ISTAND qualification program