Emerging Exploratory Biomarkers for Drug Safety Studies

Improve Early DILI/DIKI Prediction Increased Tissue Specificity

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

ELISAs for Drug-Induced Liver Injury (DILI)

BiomarkerSample TypeDescriptionAvailable AssayProduct #
Keratin 18 (K18)Serum or plasmaHighly specific biomarker for hepatocyte cell death (necrosis and apoptosis)Peviva M65® ELISA

Peviva M65 EpiDeath® ELISA

P10020

P10040

Caspase-cleaved Keratin 18 (ccK18)Serum or plasmaHighly specific specific biomarker for hepatocyte apoptosisPeviva M30 Apoptosense®P10011
Osteopontin (OPN)Serum or plasmaBiomarker for hepatic inflammation and necrosisOsteopontin

Osteopontin N-Half

DPG27158

DPG27258

Alpha Glutathione S-Transferase (a-GST)Serum or plasmaShort half-life; sensitive to rapid changes in liver damageTECO® Alpha GSTTE1056
Liver Fatty Acid Binding Protein (L-FABP, FABP1)Serum or plasmaSensitive marker for hepatic injury (leakage)Diapharma L-FABPDPGLFABP

ELISAs for Drug-Induced Kidney Injury (DIKI)

Serum, plasma, or, urineSample TypeDescriptionAvailable AssayProduct #
Alpha Glutathione S-Transferase (α-GST)UrineBiomarker for proximal tubule damageTECO® Alpha GSTTE1056
Osteopontin (OPN)UrineBiomarker for damage to loop of Henle and distal tubuleOsteopontin

Osteopontin N-Half

DPG27158

DPG27258

Liver Fatty Acid Binding Protein (L-FABP, FABP1)UrineMarker of acute kidney injury; useful for early detection of renal damage accompanying tubular dysfunctionUrinary L-FABP (FABP1)006
Cystatin C (Cys C)Serum, plasma or, urineAssay for estimation of the glomerular filtration rate (GFR); more sensitive than serum creatinine testsIMD Rapid Cystatin C31241
Neutrophil Gelatinese-Associated Lipocalin (NGAL)UrineBiomarker for distal tubularDiapharma NGAL (96)

Diapharma NGAL (2 x 96)

IMD Lipocalin-2

DPG-NGAL

DPG-2NGAL

31050

Alpha Klotho (α-Klotho)PlasmaBiomarker of impaired renal function, cytoprotectiveFluoBolt™ α-KLOTHO (MEF-FIA)FIA-1704
*Research used only in the U.S. and Canada. Not for diagnostic procedures.