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Integration of rapid PCR testing as an adjunct to NGS in diagnostic pathology services within the UK: evidence from a case series of non-squamous, non-small cell lung cancer (NSCLC) patients with follow-up
  1. Alison Finall1,2,
  2. Gareth Davies1,
  3. Trevor Jones1,
  4. Gwion Emlyn3,
  5. Pearl Huey3,
  6. Anna Mullard4
  1. 1Cellular Pathology, Swansea Bay University Health Board, Port Talbot, UK
  2. 2Medical School, Swansea University, Swansea, UK
  3. 3Cellular Pathology, Betsi Cadwaladr University Health Board, Bangor, UK
  4. 4Oncology, Betsi Cadwaladr University Health Board, Bangor, UK
  1. Correspondence to Dr Alison Finall, Cellular Pathology, Swansea Bay University Health Board, Port Talbot SA12 7BR, Neath Port Talbot, UK; afinall{at}me.com

Abstract

Aims Somatic genetic testing in non-squamous, non-small cell lung carcinoma (NSCLC) patients is required to highlight subgroups eligible for a number of novel oncological therapies. This study aims to determine whether turnaround times for reporting epidermal growth factor receptors (EGFR) by next-generation sequencing (NGS) alone is sufficient to meet the needs of lung cancer patients.

Methods We performed a retrospective case series with follow-up. Outcomes of EGFR testing (102 tests) in 96 patients by NGS were compared with a rapid, fully automated PCR-based platform (Idylla) in local histopathology laboratories.

Results Turnaround time for reporting NGS was 17 calendar days. Reporting using the Idylla EGFR Mutation Test, by contrast, gave a potential turnaround time of 3.8 days from request to authorisation. Three-quarters of patients presenting with stage IV disease had a performance status of 0, 1, or 2 but 18% experienced rapid clinical deterioration (p<0.05). A third of these patients were deceased by the time NGS reports were available.

Conclusions We discuss issues around integrating rapid PCR testing alongside NGS in multidisciplinary care pathways and strategies for mitigating against foreseeable difficulties. Dual testing for stage IV non-squamous, NSCLC patients has the potential to improve care and survival outcomes by providing access to the right test at the right time.

  • genes
  • neoplasm
  • lung neoplasms
  • medical oncology
  • pathology
  • surgical
  • polymerase chain reaction

Data availability statement

Data are available on reasonable request. Please contact first author by email with reasonable data requests.

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Data availability statement

Data are available on reasonable request. Please contact first author by email with reasonable data requests.

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Footnotes

  • Handling editor Runjan Chetty.

  • Contributors AF wrote the manuscript, scored slides for tumour nuclear content (TNC), performed data analysis and interpretation and constructed a standard operating procedure in collaboration with stakeholders. GD performed Idylla EGFR Mutation testing and collated all data. TJ scored slides for TNC for NGS send away testing. GE, AM and PH contributed to a working concept of integration with NGS data. All authors reviewed, amended and agreed manuscript content. AF is responsible for the overall content as the guarantor.

  • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

  • Competing interests None declared.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.

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