Idylla EGFR Lung Trial

Technology Study: Measuring Potential Impact of Research Use Only Rapid EGFR Testing on Standard of Care

This retrospective, observational study will compare the results of a BioCartis' EGFR mutation test on the Idylla platform with test results from SoC pathology results from tissue biopsies in the same setting. A comparable rapid testing platform for EGFR may serve as a more accessible means to diagnose, and overall, more patients treated successfully with targeted therapies. Up to 150 samples will be tested and compared with existing results.

This study will compare the results of a BioCartis' EGFR mutation test on theIdylla platform with test results from standard of care (SoC) pathology results from tissue biopsies. The Idylla™ EGFR Mutation Test, performed on the BioCartis Idylla™ System, is an in vitro diagnostic test for the qualitative detection of exon 18, exon 20, and exon 21 mutations. Additionally, exon 19 deletions and exon 20 insertions in the EGFR oncogene. A rapid testing platform for EGFR may serve as a more accessible means to diagnose, and overall, more patients treated successfully with targeted therapies.

Inclusion Criteria:

• Patients diagnosed with primary lung cancer
• Data from primary diagnosis must be included in pathology report or data entry.
• Detailed pathology report included for all samples

Exclusion Criteria:

• Limited or no tissue available
• Only tissue available is from fine needle aspiration
• Tissue blocks older than 5 years old