Trial Information

A Prospective Observational Study to Examine, in Routine Clinical Practice in the US, Practice Patterns and Impact on Clinical Decision Making Associated With the FoundationOne™ Next Generation Sequencing (NGS) Test

Molecular testing of tumors, using techniques such as next-generation sequencing (NGS),
facilitates an individualized approach to cancer treatment by sub-classifying diseases on an
individual basis. Physicians can utilize an in depth understanding of disease at a
molecular level to optimize therapy by selecting the most appropriate drugs and therapeutic
targets. Genomic profiling has identified multiple genomic aberrations that are predictive
markers for treatment response with targeted therapeutics.

FoundationOne™ is a commercially available molecular diagnostics test, for all solid tumor
types, that analyzes routine clinical specimens for somatic alterations in relevant
cancer-related genes. This validated in vitro diagnostic test, is performed in a single
Clinical Laboratory Improvement Amendments (CLIA) certified and College of American
Pathologists (CAP) approved laboratory at Foundation Medicine, Inc. It provides
individualized, potentially actionable information regarding a patient's molecular cancer
subtype that can be used by physicians to tailor treatment options.

With the recent commercial availability of the FoundationOne™ test, knowledge gaps exist
regarding practice patterns associated with the use of this test in routine clinical
practice and the impact of this test on clinical decision making. There is limited
information regarding physician and patient characteristics that determine which patients
receive the test, rationale for patient selection, and how physicians interpret and use the
test results. Findings from this study will help to optimize patient selection and maximize
the clinical impact of the test in terms of guiding therapy.