urine to kidney biomarkers for drug safety · 2017-03-24 · our kidney toxicity biomarker services...

Nextcea simultaneously detects multiple protein biomarkers in urine samples to monitor the onset and time-course of toxicity. No antigen-antibody labeling is required. Nextcea has developed specific and sensitive assays to quantitate these proteins in a single run by UPLC-MS/MS.

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Kidney Injury Protein Biomarker Assays in Monkeys and in Humans (GLP and non-GLP)

Safety Assessment by UPLC/MS/MS AnalysisThese renal toxicity protein biomarkers (KIM-1, β2-microglobulin, clusterin, trefold factor 3, cystatin C, and lipocalin-2) have been shown to provide higher sensitivity than traditional biomarkers BUN, NAG, and serum creatinine. The location and sequence of kidney damage is determined non-invasively based on levels of these proteins over time.

Our kidney toxicity biomarker services non-invasively monitor kidney damage across species. The assay detects biomarkers resulting from both drug-induced and disease-affected kidney damage. Nextcea monitored the following biomarkers by UPLC/MS/MS in urine from rats treated with gentamicin, a compound known to cause kidney toxicity.

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• KIM-1• Clusterin• Trefoil Factor 3• Cystatin C• β2-microglobulin• Lipocalin-2

Nextcea measures FDA/EMEA kidney toxicity

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About Nextcea, Inc.Nextcea, Inc. is a drug development service company dedicated to optimizing efficacy and minimizing toxicity in all phases of drug development. Nextcea integrates cross-species biomarker studies with traditional PK/PD and TK/TD. In-house platforms include HPLC/UPLC coupled to mass spectrometry LC-MS and LC-MS/MS (API-6500s and and TripleTOF 6600).

β2-microglobulin

inform@nextcea.com

Hirohide Mimura (三村博英):hiro.mimura@nextcea.com

500 W. Cummings Park, #4550 Woburn, MA 01801

781-457-4010