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

Recruitingn/aAges 18 Years - anyAllLifeOS Genomics Corporation
NCT06573073 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 Mut

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📋 Eligibility rules (as published)
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.
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What it tests

  • Not listed
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Where

1 site
National Taiwan University
Taipei, Taiwan
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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