Approaches to Enhance Quality in Lung Cancer Compact Panel Testing

Abstract

The Lung Cancer Compact Panel is a program medical device for multi-companion diagnostics using next-generation sequencers. It received approval from PMDA for four genes in December 2022 and received approval for an additional three genes in January 2024, making it a companion diagnostic testing service for a total of seven genes. This test is characterized by its high sensitivity. Also, quality control is essential for highly sensitive detection of somatic gene mutations from minute samples. This paper introduces key points for precision management and quality improvement in this test.