Summary Of Mutation Detection In Tp53

The SRM panel of TP53 mutations fulfills the NIST mission statement of providing reliable, traceable, accurate measurements or standards. In addition, this SRM can normalize data across different technological platforms, so that cancer mutation scanning information can be readily shared and easily compared among different diagnostic laboratories using the same or different analytical techniques. This panel can be used to validate-in house laboratory controls. These in-house controls could change with respect to production date (cell lines) or depletion of previously tested samples in laboratories using these materials for controls. The use of common reference materials will lower the inherent error of the measurement techniques and interlaboratory variation by ensuring that protocol optimization can always detect the SRMs. Hence, each diagnostic lab can adjust its protocol(s) to obtain an expected and reproducible results independent of the method employed (1). Equally important, the FDA can use data normalized against SRMs in its regulatory response and potentially facilitate the approval of drug therapies and/or new diagnostic technologies.

Our work compared three different established methods for the detection of single-point mutations (16). It will be useful to help make correct choices of methods and conditions for the analysis of a great number of malignant, neurological, immunological, and other diseases or for direct studies of genomic variation. The value of this information is not limited to detection of mutations of TP53, but it has implications for the analysis of other genes as well.

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