Dataset from An Open-Label, Non-randomized, Prospective Biomarker Study to Assess Analytic Concordance Between Non-invasive Testing and Tissue Testing for EGFR T790M Mutation Detection in Patients With Non-small Cell Lung Cancer

The study is being done to determine if non-invasive testing (urine and plasma testing) is as
effective as tissue testing in identifying epidermal growth factor receptor (EGFR) T790M
mutation status. EGFR is a type of protein found on the surface of cells in the body. When
this protein is mutated and becomes too active, it can lead to cancer growth. T790M is a
mutation that develops in response to treatment of the EGFR mutation.

Participating patients will have tumor tissue (via cobas test), as well as 2 plasma samples
(via cobas and Guardant360 tests) and 1 urine sample (via Trovera test), tested for EGFR
T790M mutation status. If the results of the cobas tissue and/or plasma test show that a
patient is T790M positive, they will be treated according to standard of care, which may
include treatment with osimertinib. Osimertinib is approved for use in the United States for
the treatment of EGFR T790M mutation-positive non-small cell lung cancer (NSCLC).