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Xine Yang



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    P2.14 - Targeted Therapy (ID 183)

    • Event: WCLC 2019
    • Type: Poster Viewing in the Exhibit Hall
    • Track: Targeted Therapy
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/09/2019, 10:15 - 18:15, Exhibit Hall
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      P2.14-48 - Clinical Sequencing Using a NGS-Based Multiple Gene Assay in Patients with Non-Small Cell Lung Cancer (ID 686)

      10:15 - 18:15  |  Author(s): Xine Yang

      • Abstract
      • Slides

      Background

      Patients with non-small cell lung cancer (NSCLC) often harbor driver mutations in multiple oncogenes, including EGFR, ALK, ROS1, BRAF, HER2, MET, RET, etc. The presence of gene alterations can impact the selection of and the response to targeted therapies. Testing of lung cancer for multi-gene alterations is important for identification of potentially efficacious targeted therapies. Therefore, identifying mutations in oncogenes and tailoring therapy become a standard in clinical cancer management. A genetic testing assay based on next-generation sequencing (NGS), named AmoyDx Essential NGS Panel, has been developed for multiplexed and targeted deep sequencing of variants in 10 driver genes. Clinical validation using FFPE tissue was conducted in the present study.

      Method

      A total of 294 formalin-fixed and paraffin-embedded (FFPE) tissue samples collected from NSCLC patients were tested by AmoyDx Essential NGS Panel, which enables the simultaneous detection of single-nucleotide variants (SNVs), insertions/deletions and fusions in 10 driver genes (EGFR, KRAS, NRAS, BRAF, PIK3CA, ALK, ROS1, HER2, RET, and MET) in DNA samples. DNA sequencing was performed on the Illumina sequencer. Golden standard Sanger sequencing was used as a reference method to test the same cohort. The concordance of alterations determined with the AmoyDx Essential NGS Panel was assessed compared to the reference method.

      Result

      In total of 294 samples, 98.30% (289/294) of patients were successfully detected by both AmoyDx Essential NGS Panel and Sanger sequencing. 68.86% (199/289) were identified with positive mutation/fusion by NGS assay (Table 1). The overall concordance rate of alterations determined with AmoyDx Essential NGS Panel compared with reference was 90.66%.

      Table 1 Alterations detected by NGS
      Variant type Number of patients Positive rate
      EGFR mutation 126 43.60%
      KRAS mutation 40 13.84%
      NRAS mutation 1 0.35%
      BRAF mutation 1 0.35%
      PIK3CA mutation 3 1.04%
      ALK fusion 22 7.61%
      ROS1 fusion 2 0.69%
      HER2 mutation 6 2.08%
      RET fusion 1 0.35%
      MET mutation 0 0.00%
      Total 199 68.86%

      Conclusion

      The NGS analysis with AmoyDx Essential NGS Panel represents an accurate and efficient approach to detect genetic alterations in 10 driver genes with high concordance rate of 90.66% compared with Sanger sequencing.

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