The Early-stage NSCLC Panel analyzes 4 relevant and actionable biomarkers through a combination of multi-modality methods: EGFR (PCR), ALK (FISH), ROS1 (FISH), and PD-L1 22C3 (IHC). EGFR alterations are detected using PCR amplification and detection of target DNA using complementary primer pairs and oligonucleotide probes with fluorescent dyes. The EGFR PCR component of this panel has been designed to detect EGFR highly recurrent somatic mutations in exons 18, 19, 20, and 21 of EGFR in eight reactions (Exon 18 G719X; Exon 19 deletions; Exon 20 T790M, C797S, Exon 20-Ins and S768I; Exon 21 L858R, L861Q). Some less common EGFR mutations are not detectable in this test. For a full list of EGFR variants detectable in this assay, please contact NeoGenomics client services. Test may be ordered with an opt out of PD-L1 22C3 (IHC).
The Early-stage NSCLC Panel is intended as an aid in diagnostic evaluation, prognostication, and therapy selection of early stage non-small cell lung cancer. It is appropriate for all early-stage NSCLC patients.
- Implementation of immunotherapy before molecular assessment increases toxicity. Genomic testing alongside PD-L1 expression informs immunotherapy eligibility in NSCLC1
- FDA approved adjuvant osimertinib after tumor resection in NSCLC with EGFR exon 19 deletion or exon 20 L858R mutations. ADAURA clinical trial demonstrated 73% of patients in the overall early-stage NSCLC population on the osimertinib arm were alive and disease-free at 48 months (95% CI HR of 0.27) vs 38% of those in the placebo group.
- Fewer patients had disease recurrence with osimertinib (27%) vs. placebo (60%)2
- FFPE Tissue, Paraffin block preferred. Alternatively, clients can send 1 H&E slide plus 10 unstained slides cut at 4-5 microns.
- Use positively-charged slides, 10% NBF fixative. Do not use zinc fixative.
Use refrigerated cold pack for transport. Make sure cold pack is not in direct contact with specimen.
7 days
- Gainor JF, Shaw AT, Sequist LV, Fu X, Azzoli CG, Piotrowska Z, Huynh TG, Zhao L, Fulton L, Schultz KR, Howe E, Farago AF, Sullivan RJ, Stone JR, Digumarthy S, Moran T, Hata AN, Yagi Y, Yeap BY, Engelman JA, Mino-Kenudson M. EGFR Mutations and ALK Rearrangements Are Associated with Low Response Rates to PD-1 Pathway Blockade in Non-Small Cell Lung Cancer: A Retrospective Analysis. Clin Cancer Res. 2016 Sep 15;22(18):4585-93. doi: 10.1158/1078-0432.CCR-15-3101. Epub 2016 May 25. PMID: 27225694; PMCID: PMC5026567.2 Lee CK, Man J, Lord S, Links M, Gebski V, Mok T, et al.. Checkpoint Inhibitors in Metastatic EGFR-mutated Non-Small Cell Lung Cancer- a Meta-Analysis. J Thorac Oncol (2017) 12:403–7. 10.1016/j.jtho.2016.10.007 3 Lee CK, Man J, Lord S, Cooper W, Links M, Gebski V, et al.. Clinical and Molecular Characteristics Associated With Survival Among Patients Treated With Checkpoint Inhibitors for Advanced Non-Small Cell Lung Carcinoma: A Systematic Review and Meta-Analysis. JAMA Oncol (2018) 4:210–6. 10.1001/jamaoncol.2017.4427
- Herbst RS, Wu YL, John T, Grohe C, Majem M, Wang J, Kato T, Goldman JW, Laktionov K, Kim SW, Yu CJ, Vu HV, Lu S, Lee KY, Mukhametshina G, Akewanlop C, de Marinis F, Bonanno L, Domine M, Shepherd FA, Urban D, Huang X, Bolanos A, Stachowiak M, Tsuboi M. Adjuvant Osimertinib for Resected EGFR-Mutated Stage IB-IIIA Non-Small-Cell Lung Cancer: Updated Results From the Phase III Randomized ADAURA Trial. J Clin Oncol. 2023 Apr 1;41(10):1830-1840. doi: 10.1200/JCO.22.02186. Epub 2023 Jan 31. Erratum in: J Clin Oncol. 2023 Apr 27;:JCO2300658. PMID: 36720083; PMCID: PMC10082285.