Tissue-Specific Biomarkers for Liver Injury in Gene Therapy Research

Posted: May 18, 2020

Studying liver toxicity in gene therapy research?

liver toxicity in gene therapy

Emerging Exploratory Biomarkers for Drug Safety Studies

Improve Early DILI/DIKI Prediction Increased Tissue Specificity

  • K18 (M65®)
  • ccK18 (M30®)
  • L-FABP
  • α-GST
  • NGAL/Lipocalin-2
  • Osteopontin
  • Cystatin C
  • α-Klotho

liver toxicity in gene therapy

ELISAs for Drug-Induced Liver Injury (DILI)

Biomarker Sample Type Description Available Assay Product #
Keratin 18 (K18) Serum or plasma Highly specific biomarker for hepatocyte cell death (necrosis and apoptosis)

Peviva M65® ELISA

Peviva M65 EpiDeath® ELISA



Caspase-cleaved Keratin 18 (ccK18) Serum or plasma Highly specific specific biomarker for hepatocyte apoptosis Peviva M30 Apoptosense® P10011
Osteopontin (OPN) Serum or plasma Biomarker for hepatic inflammation and necrosis


Osteopontin N-Half



Alpha Glutathione S-Transferase (a-GST) Serum or plasma Short half-life; sensitive to rapid changes in liver damage TECO® Alpha GST TE1056
Liver Fatty Acid Binding Protein (L-FABP, FABP1) Serum or plasma Sensitive marker for hepatic injury (leakage) Diapharma L-FABP DPGLFABP

Research use only in the U.S. and Canada. Not for use in diagnostic procedures.


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