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Brief Title: Idylla EGFR Lung Trial
Official Title: Technology Study: Measuring Potential Impact of Research Use Only Rapid EGFR Testing on Standard of Care
Study ID: NCT04962191
Brief Summary: 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.
Detailed Description: 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
6555 Sanger Rd, Suite 260, Orlando, Florida, United States
Name: Anthony Magliocco, MD
Affiliation: CEO and Founder
Role: PRINCIPAL_INVESTIGATOR