open access publication

Article, 2024

Performance characteristics of a polymerase chain reaction-based assay for the detection of EGFR mutations in plasma cell-free DNA from patients with non-small cell lung cancer using cell-free DNA collection tubes

PLOS ONE, ISSN 1932-6203, Volume 19, 4, Page e0295987, 10.1371/journal.pone.0295987

Contributors

May, Theresa (Corresponding author) [1] Clement, Michelle Simone [2] Halait, Harkanwal [1] Kohlmann, Alexander [3] Kohlmann, Milena [3] Lai, Jason [1] Lee, Nitta [1] Li-Sucholeiki, Xiaocheng [3] Meldgaard, Peter 0000-0002-5788-4463 [2] Joshi, Snehal [1] Scudder, Sidney A [1] Shrestha, Neelima [1] Sorensen, Boe Sandahl 0000-0002-9472-8099 [2] Kiral, Marilyn [3] O'Donnell, Patrick [1]

Affiliations

  1. [1] Roche (United States)
    2. [NORA names: United States; America, North; OECD];
  2. [2] Aarhus University Hospital
    3. [NORA names: Central Denmark Region; Hospital; Denmark; Europe, EU; Nordic; OECD];
  3. [3] AstraZeneca (United States)
    4. [NORA names: United States; America, North; OECD]

Abstract

Survival rates in non-small cell lung cancer (NSCLC) are low. Detection of circulating tumor DNA in liquid biopsy (plasma) is increasingly used to identify targeted therapies for clinically actionable mutations, including EGFR mutations in NSCLC. The cobas® EGFR Mutation Test v2 (cobas EGFR test) is FDA-approved for EGFR mutation detection in tissue or liquid biopsy from NSCLC. Standard K2EDTA tubes require plasma separation from blood within 4 to 8 hours; however, Roche Cell-Free DNA (cfDNA) Collection Tubes (Roche cfDNA tube) enable whole blood stability for up to 7 days prior to plasma separation. This analysis assessed performance of Roche cfDNA tubes with the cobas EGFR test for the detection of EGFR mutations in plasma from healthy donors or patients with NSCLC. Overall, test performance was equally robust with either blood collection tube, eg, regarding limit of detection, linearity, and reproducibility, making Roche cfDNA tubes suitable for routine clinical laboratory use in this setting. Importantly, the Roche cfDNA tubes provided more flexibility for specimen handling versus K2EDTA tubes, eg, in terms of tube mixing, plasma separation, and sample stability, and do not require processing of blood within 8 hours thereby increasing the reach of plasma biopsies in NSCLC.

Keywords

Cobas, DNA, EGFR mutation detection, EGFR mutations, EGFR testing, FDA approval, K2EDTA tubes, Roche, actionable mutations, analysis, assay, biopsy, blood, blood collection tubes, blood stability, cancer, cell lung cancer, cell-free DNA, characteristics, clinic, clinical laboratory use, clinically actionable mutations, collection tubes, days, detection, detection of EGFR mutations, detection of circulating tumor DNA, donor, eGFR, flexibility, handling, healthy donors, hours, laboratory use, limit of detection, limitations, linearity, liquid biopsy, lung cancer, mixing, mutation detection, mutations, non-small cell lung cancer, patients, performance, performance characteristics, plasma, plasma biopsies, plasma cell-free DNA, plasma separation, polymerase, polymerase chain reaction-based assay, process, processing of blood, rate, reproducibility, sample stability, samples, separation, specimen handling, specimens, stability, survival, survival rate, targeted therapy, test, test performance, therapy, tissue, tube, tumor DNA, use, whole blood stability

Funders

  • Sanofi (United States)
  • Roche (United States)

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