Abstract

Approaches For Validation of Liquid Biopsy Testing of Circulating Tumour DNA

Alison Devonshire, Science Leader, LGC Limited

The typically low concentration of ctDNA in cancer patients’ samples makes validation of analytical sensitivity a critical element in the assessment of a diagnostic test. The potential for real-time monitoring of tumor dynamics through liquid biopsy testing also necessitates a systematic evaluation of quantitative accuracy.  This presentation will discuss approaches to validate the performance of targeted methods for cancer mutations, including pre-analytical controls, and the development of reference materials and reference measurement procedures, which also support longer-term comparability and standardization of patient testing.