Idylla EGFR Lung Trial

Protean BioDiagnostics

Status: Unknown

Conditions: Oncology; Technology; Lung Cancer

Treatments: Diagnostic Test: Idylla EGFR Mutation Test

Study type: Observational

Funder types: Industry

Identifiers

NCT04962191

R20-00012

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

150 participants in 1 patient group

Lung Cancer

Description:

The Idylla EGFR Mutation Test, performed on the BioCartis Idylla System, is an in vitro diagnostic test for the qualitative detection of exon mutations. One of the biggest challenges in oncology biomarker testing is the ability to obtain samples of sufficient size and quality. This study can help test the BioCartis Idylla System against standard of care (SoC) pathology results from tissue biopsies in the same setting, ultimately being able to diagnose with a fraction of the tissue previously needed.

Treatment:

Diagnostic Test: Idylla EGFR Mutation Test