The Predictive Safety Testing Consortium (PSTC) has provided data supporting the use of various renal markers including Cystatin C, available from Random Laboratories, in a preclinical setting.
The biomarkers have been shown to outperform traditional markers, such as creatinine and blood urea nitrogen (BUN), in both specificity and sensitivity.
Cystatin C and many other renal damage biomarkers are available from Randox Laboratories.
As drug-induced toxicity is such a serious issue, it is vital that quality preclinical toxicity biomarkers are available to avoid such affected products being marketed and reaching the consumer.
A recent report from the PSTC set out to discover what makes a good safety biomarker.
The organisation concluded that, first, the marker must be present in peripheral body tissue and/or fluid, such as blood, urine, saliva, breath or cerebrospinal fluid; second, it must be easy to detect or quantify in assays that are both affordable and robust; and, third, its appearance must be associated as specifically as possible with the damage of a particular tissue, preferably in a quantifiable manner.
It was noted that the traditional renal damage markers, creatinine and BUN, conform only to the first two of these three critical criteria.
However, it has now been accepted that the following biomarkers are better in terms of specificity and sensitivity: Cystatin C; Albumin; Total protein; and Beta-2 microglobulin.
'Between June 2007 and January 2008, these data were presented to the authorities, which by April 2008 had accepted that these biomarkers outperformed the current standards,' said the study.
