The Challenge of Liver toxicity in drug development:
Early and Accurate Detection of Liver Toxicity across development stages.
Annual cost to Pharma due to late-stage toxicity failures.
DILI is the leading cause of acute liver failure worldwide.
Medications currently linked to liver injury and attrition.
People in the US taking hepatotoxic drugs needing monitoring.
Testing Limitations: Traditional indicators like ALT/AST lack specificity and are often released by non-hepatic tissues (muscle, heart), leading to false safety flags.
Detection Gap: Current methods fail to provide a comprehensive assessment by analyzing RNA and proteins separately, missing the holistic picture provided by the direct correlation between molecular stress and structural damage indicators.
LiverAce™ COMBO Kit
Multi-Omic. Single Well.
The first single-well, PCR-free assay for simultaneous miRNA-122 and CK18 detection and quantification. Both miRNA-122 and CK18 are well established markers for liver toxicity/injury. miRNA-122 provides early assessment of liver toxicity/stress while CK18 identifies liver cell death. While CK18 is not liver specific, in combination with the highly liver specific miRNA-122, the CK18 result can be tied directly to liver cell death. By overcoming the isomiR challenge and providing stage of injury (stress vs cell death) insights in a single reaction Liverace COMBO delivers high value information towards drug development success and the avoidance of late-stage failures.
For Research Use Only
Not for use in diagnostic procedures
Projected regulatory clearance in 2027
Complete drug development process
One assay for the complete drug development process. Provides accurate and reproducible assessment of drug toxicity across all stages, identifying toxicity problems early in the development lifecycle.
Diagnostic Sensitivity
Image adapted from Thulin et al. (2014) Liver Int.
Key Values
Scientific Proof
Key Publications (Biomarkers)
Clinical evidence supporting miR-122 and Keratin-18 as superior biomarkers for DILI.
Destina Chemistry (DGL-Tech)
Foundational papers on the Destina Chemistry that powers LiverAce™ assays.
Product Characteristics
Kit Specifications
| Parameter | Value |
|---|---|
| Analytes | miRNA-122 & Cytokeratin-18 |
| Platform | Luminex xMAP® (Validated on MAGPIX®, etc.) |
| Detection Method | PCR-Free Destina Chemistry |
| Time to Result | < 5 Hours |
| Sample Volume | 25 µL |
| Sample Type | Serum, Plasma |
| Quantification Range | Absolute (Calibrators included) |
Performance Characteristics
Assay Sensitivity
| Analyte | LOD (pg/mL) | LLOQ (pg/mL) |
|---|---|---|
| K18 | 60 | 137 |
| miR-122 | 2.4 | 20.58 |
Assay Procedure
Simple, Streamlined, Superior
1. Add Sample
2. Capturing & Hybridizing
3. Label
4. Read
Applications & Research Fields
- Pharma R&D & Drug Development
- CROs & Service Labs
- Preclinical Safety Assessment
- Liver Toxicity (DILI) Screening
Documentation
To ensure you receive the latest version of our documentation, these files are available upon request.
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