Days Set Up
Monday – Friday
Analytic Time

6-13 days

MiChart Code
Lung Cancer NGS Panel
Soft Order Code
NGLNG

Test Updated:

Synonyms

PIK3CA exons 2, 5, 7, 8, 10, 14, 19 and 21
AKT1 exons 4 and 7
ERBB2 (HER2) exons 19-21
BRAF exons 11 and 15
NRAS exons 2-4
KRAS exons 2-4
EGFR exons 3, 7, 15 and 18-21
NSCLC Mutation Panel by NGS
Oncomine genomic profiling
Oncomine genomic profiling

PDGFRA
NTRK3
NTRK2
NTRK1
NRAS
MYCN
MYC
MTOR
FGFR2
FGFR3
FGFR4
GNA11
GNAQ
HRAS
IDH1
IDH2
JAK1
JAK2
JAK3
KIT
KRAS
MAP2K1
MAP2K2
MET
ETV5
FGFR1
ETV4
ETV1
ESR1
CTNNB1
DDR2
EGFR
EGFRvIII
ERBB2
(HER2)
ERBB3
ERBB4
ERG
CDK6

AKT1
ALK
AR
AXL
BRAF
CCND1
CDK4
PIK3CA
PPARG
RAF1
RET
ROS1
SMO

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All specimens should be accompanied by a requisition.

Submitting Specimens

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Order Kits and Supplies

MLabs provides all the supplies necessary for the collection of specimens.

Test FAQ

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Test Overview

Test Methodology

Next-Generation Sequencing

Test Usage

Molecular testing of non-small cell lung cancer (NSCLC) is currently the standard of care for guiding the use FDA-approved targeted therapies such as inhibitors of EGFR, ALK and ROS1. In addition, there is growing clinical evidence supporting the efficacy of other treatments such as BRAF and MEK inhibitors for BRAF V600E-mutated NSCLC, crizotinib for NSCLC with MET exon 14 skipping mutations or high level MET amplification, various tyrosine kinase inhibitors (TKI) for NSCLC with RET rearrangements and ERBB2 antibodies and TKI for NSCLC with ERBB2 mutations. The use FDA-approved drugs for an off-label indication, such as these, and enrollment in clinical trials based on molecular findings is an important aspect of the care of patients with advanced stage NSCLC. This assay is designed to provide comprehensive molecular results relevant for both standard of care and emerging/investigational clinical actions. This DNA and RNA based, next-generation sequencing test targets 50 genes to detect substitution and insertion/deletion mutations (35 genes), gene amplifications (19 genes), and gene fusions (21 genes). Detectable variants relevant for NSCLC include, but are not limited to, mutations of EGFR, KRAS, NRAS, BRAF, ERBB2, MET (including exon 14 skipping), MAP2K1, PIK3CA, AKT1, FGFR2, FGFR3, DDR2, ALK, ROS1 and RET; amplification of EGFR, FGFR1, ERBB2, KRAS, PIK3CA, and MYC; and rearrangements of ALK, ROS1, RET, NTRK1/2/3, BRAF, and FGFR3. A complete list of sequenced regions, genes assessed for amplification and detectable fusion transcripts is available below.

Reference Range

Interpretive Report Provided

* Reference ranges may change over time. Please refer to the original patient report when evaluating results.

Specimen Requirements

Offsite Collection Instructions

For formalin-fixed, paraffin-embedded tissue, a block containing an area with a high percentage of neoplastic cells (for micro-/macro-dissection) is preferred. Unstained, UNBAKED slides (5-8, 10-micron slides; 10-15 if few neoplastic cells are present) with associated H&E stained slide are also acceptable. Decalcified tissue or other fixatives will be accepted and the assay attempted, however these may result in failed testing due to degraded nucleic acid. Both blocks and slides should be stored at room temperature. A Diff-Quik or Papanicolaou stained aspirate smear (preferable containing a high percentage and overall amount of neoplastic cells) is also acceptable. Store at room temperature.

Normal Volume
Formalin-fixed, paraffin-embedded tissue; Diff-Quik stained aspirate smear, Papanicolaou stained aspirate smear. Extracted DNA is also acceptable if extracted in a CLIA certified laboratory.
Minimum Volume
 

Billing Information

CPT Code
81445, 88381-TC
Pro Fee Code
 
Insurance Auth Info
 
LOINC
 

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Our High Standard

Quality that sets us apart

As the reference laboratory division of Michigan Medicine's Department of Pathology, MLabs shares the institution's commitment to applying established quality principles to clinical laboratory testing. Like other large organizations in complex, consequential fields, we rely on an established approach to monitor quality throughout the testing process.