Idylla EGFR Lung Trial

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04962191

Enrollment

150

Registered

2021-07-14

Start date

2021-08-31

Completion date

2023-01-31

Last updated

2021-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer, Oncology, Technology

Keywords

Protean BioDiagnostics

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.

Interventions

DIAGNOSTIC_TESTIdylla EGFR Mutation Test

This diagnostic test is performed on the BioCartis Idylla System for qualitative detection of exon mutations.

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Idylla EGFR Mutation Test	Retrospective tissue samples no longer than 5 years old	The primary outcome measured is if the Idylla EGFR Mutation Test is a possible alternative to diagnose EGFR mutation status in tissue samples.

Countries

United States

Contacts

Primary ContactHannah Park, BS

hannah.park@proteanbiodx.com754-242-9682

Backup ContactSo Hyeon Park, MS

sohyeon.park@proteanbiodx.com754-242-9682

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026