All Times EDT
Keywords: Liquid Biopsy-based Test, Companion Diagnostics (CDx), Analytical and Clinical Validation
Liquid biopsy-based tests using circulating tumor DNA/cell-free DNA (ctDNA/cfDNA) are more frequently used in precision medicine as part of companion diagnostics (CDx) for cancer monitoring and diagnostic. Although popular due to the quick and minimum invasive comprehensive procedure involved, such tests have their own challenges, particularly in analytical and clinical validation. Non-limiting examples of such challenges include volume constraints of clinical samples, the rarity of most of the mutations, the presence of clonal hematopoiesis of indeterminate potential (CHIP), complexity of bridging between tissue-based test and liquid biopsy-based test. In this presentation, we will discuss these challenges and potential approaches to addressing such challenges when evaluating such liquid biopsy-based tests.