Patient Preparation

No special patient preparation is necessary

Collect

Five to ten µM sections of tumor-containing tissue placed in a sterile container (>10% tumor content).
If tumor enrichment is required (tissue containing <10% tumor), tissue sections are placed on slides for macrodissection.
One accompanying H&E slide cut after all sections for extraction have been cut.

Unacceptable Conditions

Specimens fixed/processed in alternative fixatives (alcohol, Prefer) or heavy metal fixatives. Tissue containing no tumor.

Storage/Transport Temperature

Room temperature. Ship in cooled container during summer months.

Stability (from collection to initiation)

Ambient: Indefinitely; Refrigerated: Indefinitely; Frozen: Unacceptable

Remarks

Include surgical pathology report.

Cerner Orderable(s)

Lung Tumor Panel (NGS) Request

Performed

Testing: Weekly

Ordering Recommendations

Aid in therapeutic decisions for lung cancer. The test detects single nucleotide changes and small insertions and deletions.

Methodology

Next-generation sequencing - targeted panel: including BRAF (exon 15, including codon 600), EGFR (exons 18-21, including detection of exon 19 deletions, T790M, L858R and other mutations within these exons), ERBB2 (exon 20), and KRAS (exons 2-4, including codons 12, 13, 59, 61 and 146) genes.

Reported

TAT:  10 - 14 days

Synonyms

  • Solid Tumor Next Gen sequencing

Reference Interval

No mutations detected

Interpretive Data

INTERPRETATION for Negative results
No mutations were detected.  BRAF mutations occur in 1-2% of non-small cell lung cancers (NSCLCs).  The combination of dabrafenib and trametinib may be used to target BRAF V600E mutation containing tumors.  EGFR mutations occur in 10-15% of NSCLCs, and tumors with an EGFR mutation may be treated with a targeted tyrosine kinase inhibitor.  ERBB2 mutations, predominantly within exon 20, occur in 1-2% of NSCLCs and may respond to ERBB2 targeted therapy.  KRAS mutations occur in 20-30% of NSCLCs, typically are exclusive of other oncogenic driver mutations and generally predict lack of response to tyrosine kinase inhibitor therapy.
 
References:
Chuang, J.C. et al, “ERBB2-mutated metastatic non-small cell lung cancer: Response and resistance to targeted therapies” (2017) Journal of Thoracic Oncology V. 12(5), pp. 933-942.
Hanna, N. et al, “Systemic therapy for stage IV non-small-cell lung cancer: American Society of Clinical Oncology Clinical Practice Guideline Update” (2017) Journal of Clinical Oncology V. 35(30) pp. 3484-3515.
Kris, M.G. et al, “Targeting HER2 aberrations as actionable drivers in lung cancers: phase II trial of the pan-HER2 tyrosine kinase inhibitor dacomitinib in patients with HER2-mutant or amplified tumors” (2015) Annals of Oncology V. 26, pp. 1421-1427.
Lindeman, N.I. et al, “Updated molecular testing guideline for the selection of lung cancer patients for treatment with targeted tyrosine kinase inhibitors” (2018) Arch. Pathol. Lab. Med. V. 142(3), pp. 321-346.
Planchard, D. et al, “An open-label phase 2 trial of dabrafenib plus trametinib in patients with previously treated BRAF V600E-mutant metastatic non-small cell lung cancer” (2016) Lancet Oncol. V. 17(7), pp. 984-993.
Planchard, D. et al, “Dabrafenib plus trametinib in patients with previously untreated BRAF V600E-mutant metastatic non-small-cell lung cancer” (2017)  The Lancet Oncology V. 18(10), pp. 1307-1316.

CPT Codes

81210, 81235, 81275, 81276, 81479
Collection

Patient Preparation

No special patient preparation is necessary

Collect

Five to ten µM sections of tumor-containing tissue placed in a sterile container (>10% tumor content).
If tumor enrichment is required (tissue containing <10% tumor), tissue sections are placed on slides for macrodissection.
One accompanying H&E slide cut after all sections for extraction have been cut.

Unacceptable Conditions

Specimens fixed/processed in alternative fixatives (alcohol, Prefer) or heavy metal fixatives. Tissue containing no tumor.

Storage/Transport Temperature

Room temperature. Ship in cooled container during summer months.

Stability (from collection to initiation)

Ambient: Indefinitely; Refrigerated: Indefinitely; Frozen: Unacceptable

Remarks

Include surgical pathology report.
Ordering

Cerner Orderable(s)

Lung Tumor Panel (NGS) Request

Performed

Testing: Weekly

Ordering Recommendations

Aid in therapeutic decisions for lung cancer. The test detects single nucleotide changes and small insertions and deletions.

Methodology

Next-generation sequencing - targeted panel: including BRAF (exon 15, including codon 600), EGFR (exons 18-21, including detection of exon 19 deletions, T790M, L858R and other mutations within these exons), ERBB2 (exon 20), and KRAS (exons 2-4, including codons 12, 13, 59, 61 and 146) genes.

Reported

TAT:  10 - 14 days

Synonyms

  • Solid Tumor Next Gen sequencing
Result Interpretation

Reference Interval

No mutations detected

Interpretive Data

INTERPRETATION for Negative results
No mutations were detected.  BRAF mutations occur in 1-2% of non-small cell lung cancers (NSCLCs).  The combination of dabrafenib and trametinib may be used to target BRAF V600E mutation containing tumors.  EGFR mutations occur in 10-15% of NSCLCs, and tumors with an EGFR mutation may be treated with a targeted tyrosine kinase inhibitor.  ERBB2 mutations, predominantly within exon 20, occur in 1-2% of NSCLCs and may respond to ERBB2 targeted therapy.  KRAS mutations occur in 20-30% of NSCLCs, typically are exclusive of other oncogenic driver mutations and generally predict lack of response to tyrosine kinase inhibitor therapy.
 
References:
Chuang, J.C. et al, “ERBB2-mutated metastatic non-small cell lung cancer: Response and resistance to targeted therapies” (2017) Journal of Thoracic Oncology V. 12(5), pp. 933-942.
Hanna, N. et al, “Systemic therapy for stage IV non-small-cell lung cancer: American Society of Clinical Oncology Clinical Practice Guideline Update” (2017) Journal of Clinical Oncology V. 35(30) pp. 3484-3515.
Kris, M.G. et al, “Targeting HER2 aberrations as actionable drivers in lung cancers: phase II trial of the pan-HER2 tyrosine kinase inhibitor dacomitinib in patients with HER2-mutant or amplified tumors” (2015) Annals of Oncology V. 26, pp. 1421-1427.
Lindeman, N.I. et al, “Updated molecular testing guideline for the selection of lung cancer patients for treatment with targeted tyrosine kinase inhibitors” (2018) Arch. Pathol. Lab. Med. V. 142(3), pp. 321-346.
Planchard, D. et al, “An open-label phase 2 trial of dabrafenib plus trametinib in patients with previously treated BRAF V600E-mutant metastatic non-small cell lung cancer” (2016) Lancet Oncol. V. 17(7), pp. 984-993.
Planchard, D. et al, “Dabrafenib plus trametinib in patients with previously untreated BRAF V600E-mutant metastatic non-small-cell lung cancer” (2017)  The Lancet Oncology V. 18(10), pp. 1307-1316.
Administrative

CPT Codes

81210, 81235, 81275, 81276, 81479

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