Validating dPCR-Based Laboratory Developed Tests for Cancer Diagnosis and Disease Monitoring

Traditionally, test developers have used quantitative PCR (qPCR) to create highly specific laboratory-developed tests (LDTs). However, digital PCR (dPCR) is emerging as the preferred technology for newer LDTs because it provides absolute nucleic acid quantification and greater precision than qPCR. While LDTs that use these methods must meet similar criteria and standards, there are technological differences that can have implications for validating dPCR-based tests.

In this GEN webinar, Kathleen Davis, Associate Director of Operations at iCura Diagnostics, will describe her experience with validating a highly sensitive dPCR-based LDT for detecting low-frequency BRAF V600E mutations. This assay has a limit of detection of 0.07 percent and can distinguish the V600E mutation from wildtype and non-specific mutations. During the webinar, you’ll learn the details of the validation process, which uses FFPE tissue from solid tumor biopsies and cell-line derived DNA. You’ll also hear about how its accuracy compares to conventional Sanger and next-generation sequencing.

A live Q&A session will follow the presentation, offering you a chance to pose questions to our expert panelist.