Exploring the use of in silico reference files in clinical trials

May 2023

As the precision medicine era advances, in silico reference files (ISRFs) are economical materials that laboratories and test developers can use to assess bioinformatics pipeline performance to support next-generation-sequencing test development, validation, and quality assurance.

In March 2023, a select group of stakeholders came together to discuss a new application for ISRFs: use in clinical trials that employ multiple clinical trial assays and laboratory partners to enroll patients. Participants discussed the potential benefits and limitations of ISRFs in this context, with many underscoring the critical need for nimble reference samples to support oncology treatment and test development.