Randox Provides the Gold Standard in Renal Damage Testing – Cystatin C
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The Predictive Safety Testing Consortium (PSTC) has provided data which supports the use of various renal markers, including Cystatin C, 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.
Due to drug-induced toxicity being 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.
They concluded; “first, the marker must be present in peripheral body tissue and/or fluid (e.g., 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 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 by regulators that the following biomarkers are superior in specificity and sensitivity:
• Cystatin C
• Albumin
• Total protein
• ?2-microglobulin
As further confirmation, the study stated; “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.”
Due to drug-induced toxicity being 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.
They concluded; “first, the marker must be present in peripheral body tissue and/or fluid (e.g., 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 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 by regulators that the following biomarkers are superior in specificity and sensitivity:
• Cystatin C
• Albumin
• Total protein
• ?2-microglobulin
As further confirmation, the study stated; “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.”
