Non−Small-cell Lung Cancer (NSCLC) Therapeutic Profile II

CPT: 81235; 81275; 81276; 88381
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Test Includes

ALK FISH analysis; EGFR mutation analysis; KRAS mutation analysis


Special Instructions

Please provide a copy of the pathology report. Direct any questions regarding this test to customer service at 800-345-4363. A subsequent blood sample may be requested in order to confirm the somatic origin of an identified mutation. The ALK FISH, Lung, Non-Small Cell [512084] portion of this profile is back-end billed. Bill code(s) will be added after testing is completed.


Expected Turnaround Time

10 - 14 days


Specimen Requirements


Specimen

Formalin-fixed, paraffin-embedded (FFPE) tissue block or slides


Volume

Formalin-fixed, paraffin-embedded (FFPE) tissue block or 14 precut unstained slides in 5-μM sections and one matching H&E slide. Samples with >4 mm² and ≥50% tumor content are preferred.


Storage Instructions

Room temperature


Causes for Rejection

Block containing no tumor tissue; decalcified specimens; broken or stained slides


Test Details


Use

Non−small-cell lung cancer (NSCLC) is the leading cause of death from cancer in both men and women in the US. A subgroup of NSCLC patients has shown clinical responsiveness to the epidermal growth factor receptor (EGFR) inhibitors gefitinib (Iressa®) and erlotinib (Tarceva®). In the majority of patients with highly responsive tumors, the tumor contains somatic mutations within the EGFR tyrosine kinase domain. The presence of a somatic EGFR mutation is significantly associated with deferential responsiveness or resistance to gefitinib and erlotinib, and is strongly predictive of prolonged survival in NSCLC patients.

KRAS mutations in NSCLC are predictive of lack of therapeutic efficacy with EGFR tyrosine kinase inhibitor (erlotinib and gefitinib). Patients with mutations appear to have a shorter survival than patients with wild-type KRAS. A rearrangement of ALK gene is associated with the development of non-small cell lung cancer (NSCLC). The ALK gene FISH assay is designed to detect ALK rearrangements in patients with non-small lung cancer who may benefit from treatment of tyrosine kinase inhibitor therapy.


Limitations

The EGFR test is designed to detect mutations in exons 18, 19, 20, and 21 of the EGFR gene. These mutations account for >99% of all reported EGFR mutations in NSCLC patients. The KRAS test is designed to detect mutations in exons 2, 3, and 4 of the KRAS gene. Samples with results reported as "no mutation detected" may harbor mutations that are not detected by the assay.

Detection of mutation is dependent on sample integrity and the amount of amplifiable DNA present in the specimen. The methods used in EGFR and KRAS assays are highly selective and, depending on the total amount of DNA present, can detect approximately 2% to 20% of mutant EGFR and 5% KRAS mutation in a background of wild-type genomic DNA.

This test was developed and its performance characteristics determined by Labcorp. It has not been cleared or approved by the Food and Drug Administration.


Methodology

EGFR, KRAS: SNaPshot Multiplex PCR; ALK FISH Analysis


References

Jänne PA, Engelman JA, Johnson BE. Epidermal growth factor receptor mutations in non−small-cell lung cancer: Implications for treatment and tumor biology. J Clin Oncol. 2005 May 10; 23(14):3227-3234. 15886310

LOINC® Map

Order Code Order Code Name Order Loinc Result Code Result Code Name UofM Result LOINC
388103 EGFR/KRAS PCR, ALK FISH, Lung 481061 KRAS Mutation Analysis Result 21702-6
388103 EGFR/KRAS PCR, ALK FISH, Lung 481062 Indications: 42349-1
388103 EGFR/KRAS PCR, ALK FISH, Lung 481063 Specimen Location: N/A
388103 EGFR/KRAS PCR, ALK FISH, Lung 481064 Specimen Type: 31208-2
388103 EGFR/KRAS PCR, ALK FISH, Lung 481066 Block Number: 57723-9
388103 EGFR/KRAS PCR, ALK FISH, Lung 481072 Nucleotide Change: 48004-6
388103 EGFR/KRAS PCR, ALK FISH, Lung 481073 Amino Acid Change: 48005-3
388103 EGFR/KRAS PCR, ALK FISH, Lung 481074 Director Review: 72486-4
388103 EGFR/KRAS PCR, ALK FISH, Lung 481067 Background: 21703-4
388103 EGFR/KRAS PCR, ALK FISH, Lung 481506 Methodology: 49549-9
388103 EGFR/KRAS PCR, ALK FISH, Lung 481071 References: 75608-0
388103 EGFR/KRAS PCR, ALK FISH, Lung 480903 Microdissection Performed 8100-0
388103 EGFR/KRAS PCR, ALK FISH, Lung 481133 Referring Physician 18781-5
388103 EGFR/KRAS PCR, ALK FISH, Lung 481134 Treating Physician 18781-5
388103 EGFR/KRAS PCR, ALK FISH, Lung 481135 Body Site 39111-0
388103 EGFR/KRAS PCR, ALK FISH, Lung 481136 Client Specimen ID N/A
388103 EGFR/KRAS PCR, ALK FISH, Lung 481137 Specimens Received 31208-2
388103 EGFR/KRAS PCR, ALK FISH, Lung 481138 Clinical Data 55752-0
388103 EGFR/KRAS PCR, ALK FISH, Lung 481140 Interpretation 62365-2
388103 EGFR/KRAS PCR, ALK FISH, Lung 481141 Analytical Results 21702-6
388103 EGFR/KRAS PCR, ALK FISH, Lung 481142 Comments 77202-0
388103 EGFR/KRAS PCR, ALK FISH, Lung 481143 Signed By 19139-5
388103 EGFR/KRAS PCR, ALK FISH, Lung 481144 Disclaimers N/A
388103 EGFR/KRAS PCR, ALK FISH, Lung 481145 PDF 51969-4
388103 EGFR/KRAS PCR, ALK FISH, Lung 489361 EGFR Result: 21665-5
388103 EGFR/KRAS PCR, ALK FISH, Lung 489365 Interpretation: 50398-7
388103 EGFR/KRAS PCR, ALK FISH, Lung 489362 Nucleotide change: 48004-6
388103 EGFR/KRAS PCR, ALK FISH, Lung 489363 Amino acid change: 48005-3
388103 EGFR/KRAS PCR, ALK FISH, Lung 489437 Background: 21666-3
388103 EGFR/KRAS PCR, ALK FISH, Lung 489366 Director Review: 72486-4
388103 EGFR/KRAS PCR, ALK FISH, Lung 489364 Block Number: 57723-9
388103 EGFR/KRAS PCR, ALK FISH, Lung 481184 Referring Physician 18781-5
388103 EGFR/KRAS PCR, ALK FISH, Lung 481185 Treating Physician 18781-5
388103 EGFR/KRAS PCR, ALK FISH, Lung 481186 Body Site 39111-0
388103 EGFR/KRAS PCR, ALK FISH, Lung 481187 Client Specimen ID N/A
388103 EGFR/KRAS PCR, ALK FISH, Lung 481188 Specimens Received 31208-2
388103 EGFR/KRAS PCR, ALK FISH, Lung 481189 Clinical Data 55752-0
388103 EGFR/KRAS PCR, ALK FISH, Lung 481191 Interpretation 62365-2
388103 EGFR/KRAS PCR, ALK FISH, Lung 481192 Analytical Results 21665-5
388103 EGFR/KRAS PCR, ALK FISH, Lung 481193 Comments 77202-0
388103 EGFR/KRAS PCR, ALK FISH, Lung 481464 Methodology 49549-9
388103 EGFR/KRAS PCR, ALK FISH, Lung 481465 References: 75608-0
388103 EGFR/KRAS PCR, ALK FISH, Lung 481194 Signed By 19139-5
388103 EGFR/KRAS PCR, ALK FISH, Lung 481195 Disclaimers N/A
388103 EGFR/KRAS PCR, ALK FISH, Lung 481196 PDF 51969-4
388103 EGFR/KRAS PCR, ALK FISH, Lung 512119 Specimen Type 66746-9
388103 EGFR/KRAS PCR, ALK FISH, Lung 512120 Cells Counted 64089-6
388103 EGFR/KRAS PCR, ALK FISH, Lung 512121 Cells Analyzed 64086-2
388103 EGFR/KRAS PCR, ALK FISH, Lung 512122 FISH Result 78233-4
388103 EGFR/KRAS PCR, ALK FISH, Lung 512133 Interpretation 78210-2
388103 EGFR/KRAS PCR, ALK FISH, Lung 512134 Director Review 48672-0
388103 EGFR/KRAS PCR, ALK FISH, Lung 512123 PDF 51967-8

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The LOINC® codes are copyright © 1994-2021, Regenstrief Institute, Inc. and the Logical Observation Identifiers Names and Codes (LOINC) Committee. Permission is granted in perpetuity, without payment of license fees or royalties, to use, copy, or distribute the LOINC® codes for any commercial or non-commercial purpose, subject to the terms under the license agreement found at https://loinc.org/license/. Additional information regarding LOINC® codes can be found at LOINC.org, including the LOINC Manual, which can be downloaded at LOINC.org/downloads/files/LOINCManual.pdf