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Ensuring patients with mNSCLC receive biomarker testing requires a multidisciplinary approach


Communication among oncologists and interventional radiologists and pathologists is necessary to obtain adequate biopsy samples and minimize loss of biopsy material1-3


Specimen Collection
Collection of adequate tissue, fluid, or blood samples1,2,4
Interventionalist, Pulmonologist

Molecular Testing
Molecular tests ordered by a pathologist (by protocol) or medical oncologist in eligible patients with mNSCLC1,2,4
Pathologist, Oncologist, Molecular Pathologist, Anatomical Pathologist

Patient Navigation and Support
Counsel patients on biomarker testing importance; assist in MDT communication and/or coordination5
Oncology Nurse, Nurse Navigator, Oncologist

Management Plan
Clinical decisions are based on tumor features (histologic subtype and biomarker profile)1,2,4
Oncologist, Laboratory Director


MDT, multidisciplinary team; mNSCLC, metastatic non-small cell lung cancer.

Obtaining adequate tissue for molecular testing can be challenging6

Tissue biopsy samples graph
  • The vast majority of advanced NSCLC routine clinical samples are small-core needle biopsies, and ~21.2% of them have <25% tumor content



Traditional “tissue-sparing” approaches may not provide adequate amount of tissue3,7,8


  • A “tissue-sparing” algorithm for molecular tests is intended to minimize loss of material and preserve the sample for multiple sequential molecular studies3
  • However, up to a 31% failure rate may occur while obtaining adequate tissue just for diagnosis7,8


Tissue sparing algorithm


ALK, anaplastic lymphoma kinase; BRAF, v-raf murine sarcoma viral oncogene homolog B1; EGFR, epidermal growth factor receptor; FISH, fluorescence in situ hybridization; HER2, human epidermal growth factor receptor 2; H&E, hematoxylin and eosin; KRAS, Kirsten rat sarcoma; IHC, immunohistochemistry; PCR, polymerase chain reaction; ROS1, ROS proto-oncogene 1, tyrosine receptor kinase.

Does your patient have enough tissue?


Yes? Tissue NGS may be an option

Successful NGS testing in 95.9% of cases has these tissue requirements9:

1 mm2 for fresh-frozen biopsy, 5 unstained slides of FFPE  biopsy, 1 unstained slide for FFPE  operation specimens


No? Liquid NGS may help alleviate the "tissue issue"

Liquid biopsy, a noninvasive option that analyzes tumor-derived material from nonsolid biological tissue (blood, saliva, urine), may be considered when10:

  • Tumor tissue is inadequate or unavailable11
  • Biopsy is delayed or contraindicated11
  • The patient is medically unfit for tissue biopsy11
  • The patient refuses tissue biopsy or rebiopsy8,11
  • The patient is unable to travel for tissue biopsy and mobile phlebotomy is an option12
  • There are significant delays in acquiring adequate tumor tissue samples11,13-15

Liquid biopsy is not yet recommended as a replacement for tissue biopsy, and retesting using tissue biopsy is recommended if a liquid biopsy test result is negative.11



FFPE, formalin-fixed paraffin-embedded; NA, not applicable; NGS, next-generation sequencing.




  1. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Non-Small Cell Lung Cancer V.3.2023. © National Comprehensive Cancer Network, Inc. 2023. All rights reserved. Accessed July 7, 2023. To view the most recent and complete version of the guideline, go online to The National Comprehensive Cancer Network makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.
  2. Ofiara LM, Navasakulpong A, Beaudoin S, Gonzalez AV. Front Oncol. 2014;4:253. doi: 10.3389/fonc.2014.00253.
  3. Conde E, Angulo B, Izquierdo E, et al. Clin Transl Oncol. 2013;15(7):503-508.
  4. Pennell NA, Arcila ME, Gandara DR, West H. Am Soc Clin Oncol Educ Book. 2019;39:531-542.
  5. Peckham J, Mott-Coles S. Clin J Oncol Nurs. 2018;22(6):656-662.
  6. Yu TM, Morrison C, Gold EJ, Tradonsky A, Layton AJ. Clin Lung Cancer. 2019;20(1):20-29.
  7. Iding JS, Krimsky W, Browning R. J Thorac Dis. 2016;8(suppl 6):S488-S493.
  8. Drilon A, Wang L, Arcila ME, et al. Clin Cancer Res. 2015;21(16):3631-3639.
  9. Cho M, Ahn S, Hong M, et al. Oncotarget. 2017;8(26):42478-42486.
  10. Castro-Giner F, Gkountela S, Donato C, et al. Diagnostics (Basel). 2018;8(2):31.
  11. Rolfo C, Mack PC, Scagliotti GV, et al. J Thorac Oncol. 2018;13(9):1248-1268.
  12. Foundation Medicine, Inc. Foundation Medicine mobile phlebotomy. Accessed October 7, 2021.
  13. De Rubis G, Rajeev Krishnan S, Bebawy M. Trends Pharmacol Sci. 2019;40(3):172-186.
  14. Merker JD, Oxnard GR, Compton C, et al. J Clin Oncol. 2018;36(16):1631-1641.
  15. Gregg JP, Li T, Yoneda KY. Transl Lung Cancer Res. 2019;8(3):286-301.


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