Observational studyScientific reports2016
Implementation and Quality Control of Lung Cancer EGFR Genetic Testing by MALDI-TOF Mass Spectrometry in Taiwan Clinical Practice.
Observational study in Scientific reports, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.
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Who cites it
11 citing papers in PubMed, 19 citations in OpenAlex.
- IsoPS-DIA: Dual Functionality of Absolute Targeted Quantification and Global Proteome Profiling.Analytical chemistry · 2026Article
- Real-world therapeutic strategies and survival outcomes in advanced HER2 -mutant non-small cell lung cancer.Journal of the Chinese Medical Association : JCMA · 2025Article
- Importance of driver gene mutation assessment and targeted therapy for patients with early‑stage non‑small cell lung cancer and non‑R0 resection.Oncology letters · 2025Article
- Next-generation sequencing reveals genetic heterogeneity and resistance mechanisms in patients withERJ open research · 2024Article
- Rapid Identification of Nontuberculous Mycobacterium Species from Respiratory Specimens Using Nucleotide MALDI-TOF MS.Microorganisms · 2023Article
- Molecular Genetic Techniques in Biomarker Analysis Relevant for Drugs Centrally Approved in Europe.Molecular diagnosis & therapy · 2022Review
- The relative importance of predictive factors for single first-generation EGFR-TKI use for more than 5 years in patients with advanced non-small cell lung cancer: Taiwan multicenter TIPS-5 study.Therapeutic advances in medical oncology · 2021Article
- Extensive-Stage Small Cell Carcinoma Transformation From EGFR Del19-Mutant Lung Adenocarcinoma on Gefitinib at the Twelfth-Year Follow-Up Case Report.Frontiers in oncology · 2021Article
- Mutational monitoring of EGFR T790M in cfDNA for clinical outcome prediction in EGFR-mutant lung adenocarcinoma.PloS one · 2018Article
- Tumor PD-L1 Expression and Clinical Outcomes in Advanced-stage Non-Small Cell Lung Cancer Patients Treated with Nivolumab or Pembrolizumab: Real-World Data in Taiwan.Journal of Cancer · 2018Article
- Rapid Sputum Multiplex Detection of the M. tuberculosis Complex (MTBC) and Resistance Mutations for Eight Antibiotics by Nucleotide MALDI-TOF MS.Scientific reports · 2017Article
Corrections and comments
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Authors and funding
7 authors at 4 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Molecular diagnostics in cancer pharmacogenomics is indispensable for making targeted therapy decisions especially in lung cancer. For routine clinical practice, the flexible testing platform and implemented quality system are important for failure rate and turnaround time (TAT) reduction. We established and validated the multiplex EGFR testing by MALDI-TOF MS according to ISO15189 regulation and CLIA recommendation in Taiwan. Totally 8,147 cases from Aug-2011 to Jul-2015 were assayed and statistical characteristics were reported. The intra-run precision of EGFR mutation frequency was CV 2.15% (L858R) and 2.77% (T790M); the inter-run precision was CV 3.50% (L858R) and 2.84% (T790M). Accuracy tests by consensus reference biomaterials showed 100% consistence with datasheet (public database). Both analytical sensitivity and specificity were 100% while taking Sanger sequencing as the gold-standard method for comparison. EGFR mutation frequency of peripheral blood mononuclear cell for reference range determination was 0.002 ± 0.016% (95% CI: 0.000-0.036) (L858R) and 0.292 ± 0.289% (95% CI: 0.000-0.871) (T790M). The average TAT was 4.5 working days and the failure rate was less than 0.1%. In conclusion, this study provides a comprehensive report of lung cancer EGFR mutation detection from platform establishment, method validation to clinical routine practice. It may be a reference model for molecular diagnostics in cancer pharmacogenomics.
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