Evaluation of Clinical Performance and IVD Test of LifeOS Digital PCR Liquid Biopsy Kits for EGFR T790M Mutation

Liquid biopsy plays a pivotal role in cancer therapeutics, encompassing critical applications such as early cancer detection, disease progression monitoring, and tailored treatment plan formulation, heralded as a pivotal avenue for the future of cancer management. Established in 2015, LifeOS Genomics Co., Ltd. stands among the select few domestic enterprises pioneering the autonomous development of digital Polymerase Chain Reaction (PCR) technology. The company's automated nucleic acid amplification quantitative analysis platform (QLoci™ md1000 Analyzer) demonstrates outstanding proficiency, featuring sixty thousand wells per PCR chip. Integrating digital PCR technology, it elevates analytical sensitivity beyond 0.1%. LifeOS commissioned the Core Laboratory of Pharmacogenomics at the National Taiwan University to conduct clinical validation assessments for their developed "EGFR T790M Mutation Detection Assay Kit." This assay kit secured official registration by the Taiwan Food and Drug Administration (TFDA) as a Laboratory Developed Test (LDT) in 2023, permitting the issuance of medical testing reports.

This initiative aims to validate the detection capabilities of LifeOS Genomics Co., Ltd.'s "EGFR T790M Mutation Detection Assay Kit" prospectively clinically in clinical lung cancer patient plasma samples, addressing unmet clinical needs for early cancer detection, disease progression monitoring, and aiding physicians in diagnosis and pharmacotherapy.

Study Overview

• Status: Recruiting
• Conditions: Non Small Cell Lung Cancer; EGFR T790M

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Sung-Liang Yu, PhD; Phone Number: 288697 +886 23123456; Email: slyu@ntu.edu.tw

Study Locations

• Taiwan
  • Taipei, Taiwan, 10617
    • Recruiting
    • National Taiwan University
    • Contact: Sung-Liang Yu, PhD; Phone Number: 288697 +886 23123456; Email: slyu@ntu.edu.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Late stage NSCLC patients with EGFR activating mutations

Description

Inclusion Criteria:

1. aged ≥18 years old.
2. Patients with Stage IIIB or IV non-small cell lung cancer (NSCLC) with EGFR mutations.

Exclusion Criteria:

1. Pregnant women.
2. Any condition that, in the opinion of the doctors, may pose a severe risk to the patient or interfere with trial results or participation.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
NSCLC with EGFR mutation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Concordance in detecting EGFR T790M using the LifeOS EGFR T790M cfDNA Detection Kit and the cobas® EGFR Mutation Test v2.	The primary endpoint is to assess the concordance between the LifeOS EGFR T790M cfDNA Detection Kit and the cobas® EGFR Mutation Test v2 in detecting the presence of EGFR T790M in cfDNA from plasma.	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity of the LifeOS EGFR T790M cfDNA Detection Kit relative to the cobas® EGFR Mutation Test v2.	The secondary endpoint is to assess the sensitivity between the LifeOS EGFR T790M cfDNA Detection Kit and the cobas® EGFR Mutation Test v2 in detecting the presence of EGFR T790M in cfDNA from plasma.	5 years
Specificity of the LifeOS EGFR T790M cfDNA Detection Kit relative to the cobas® EGFR Mutation Test v2.	The secondary endpoint is to assess the specificity between the LifeOS EGFR T790M cfDNA Detection Kit and the cobas® EGFR Mutation Test v2 in detecting the presence of EGFR T790M in cfDNA from plasma.	5 years

Collaborators and Investigators

• Sponsor: LifeOS Genomics Corporation
• Collaborators: National Taiwan University Hospital; Chang Gung Memorial Hospital; Far Eastern Memorial Hospital; Tri-Service General Hospital; Chung Shan Medical University; National Taiwan University; National Taiwan University Cancer Center
• Investigators: Principal Investigator: Sung-Liang Yu, PhD, National Taiwan University

Study record dates

Study Major Dates

• Study Start (Actual): September 6, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: August 11, 2024
• First Submitted That Met QC Criteria: August 25, 2024
• First Posted (Actual): August 27, 2024

Study Record Updates

• Last Update Posted (Estimated): November 18, 2024
• Last Update Submitted That Met QC Criteria: November 14, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: EGFR T790M; Liquid biopsy; digital Polymerase Chain Reaction (PCR)
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: 202405068DSA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No