NCT04962191

Idylla EGFR Lung Trial

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 150 (estimated)
• Sponsor: Anthony Magliocco · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lung Cancer
• Technology
• Oncology

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Idylla EGFR Mutation Test	This diagnostic test is performed on the BioCartis Idylla System for qualitative detection of exon mutations.

Timeline

• Start date: 2021-08-01
• Primary completion: 2022-12-01
• Completion: 2023-01-01
• First posted: 2021-07-14
• Last updated: 2021-07-14

Locations

1 site across 1 country: United States