Author of

• 18974

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  P3.02 - Biology/Pathology (ID 620)

  • Event: WCLC 2017
  • Type: Poster Session with Presenters Present
  • Track: Biology/Pathology
  • Presentations: 1
  • Moderators:
  • Coordinates: 10/18/2017, 09:30 - 16:00, Exhibit Hall (Hall B + C)

  • 24000

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    P3.02-052 - Stability of EGFR Mutations in Whole Blood and Plasma in Patients with NSCLC (ID 9812)

    09:30 - 09:30  |  Author(s): T. May
    • Abstract

    Background:
    The cobas[®] EGFR Mutation Test v2 (Roche Molecular Systems Inc.) has recently been IVD approved in the US for detection of epidermal growth factor receptor (EGFR) mutations in blood samples. Knowledge of the EGFR mutation status in non-small cell lung cancer (NSCLC) patients is essential to designing optimal, individualised treatment. However, implementing blood-based analyses to detect cancer-specific mutations demands standardized preanalytical conditions, but research in this field is rare and inadequate. The aim of this project was to investigate if the result of the EGFR mutation test was influenced by storage of blood and plasma samples under various preanalytical conditions.
    
    Method:
    Blood drawn in EDTA tubes from patients with advanced NSCLC was used to establish EGFR mutation stability. The mutation status and amount of mutated DNA was determined using the cobas[®] EGFR Mutation Test v2.
    
    Result:
    EGFR mutations are stable in whole blood stored at 32°C for up to 8 hours. The EGFR mutations are also stable in plasma stored at: 32°C for up to 24 hours; 2-8°C for up to three days; and at -20°C and at -80°C for 31 days. Investigation of plasma stored for 13 months at -20°C and at -80°C is ongoing.
    
    Conclusion:
    Our results establish that DNA extracted from blood or plasma stored for an extended period or under different temperatures is suitable for use with the cobas[®] EGFR Mutation Test v2, verifying the robustness, accuracy, and suitability of the assay in the clinic. The results support shipping patient samples to a testing center for EGFR mutation testing using the cobas[®] EGFR Mutation Test v2, enabling more patients to benefit from targeted therapy based on EGFR mutation status.