Case Study 1: In vitro biomarker assay development for companion animal research.
Challenge
There is a great deal of interest in the companion animal health research area, particularly related to arthritis and bone health, obesity, and renal and liver function. Despite this interest, many biomarker assays that have been established for health monitoring and preclinical studies have yet to be developed for use with canine or feline samples.
Solution
We have recently developed a panel of canine and feline renal funtion biomarker assays. The work began when a client requested that we assay canine and feline urine samples for a number of biomarkers linked to kidney function. However, none of the biomarker assays were currently available for use with dog or cat. After examining sequence alignments and determining available reagents, we initiated an assay validation plan of 35 potential renal function biomarkers for companion animal samples.
Validations were performed using client-provided blinded samples that were clinically relevant for kidney function analyses. From the initial group of potential markers, we were able to successfully develop a panel of 18 markers that have been shown to be useful for monitoring kidney function. During the validation studies we determined assay linearity, examined matrix effects, and optimized the assays for use with canine and feline urine samples. We were also able to create internal control samples that ensure consistency across multiple runs of the assays over time. These 18 markers of renal function have been used for analysis of canine and feline samples for studies involving 20-40 animals in several treatment groups coverin time points of up to 6 months.
Results
Based on the success of the urine validation studies, work continues in expanding these markers for use with other sample types. Similar projects have been undertaken to develop useful panels for both canine and feline arthritis and bone health studies, which are now available.
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