LUNGSEQ Panel Concurrent : 1004876

Please provide most recent Pathology report.

Test Code

Alias/See Also
LungSEQ; Non Small Cell Lung Cancer; LungSEQ by NGS; KRAS; KRAS G12C; G12C

CPT Codes
81445, 88271x8, 88275x4

This panel includes LUNGSEQ Panel, ALK by FISH, ROS1 by FISH, c-MET by FISH, RET by FISH, and PD-L1 by IHC.

LUNGSEQ Panel Components: AKT1 (p.E17K); BRAF (p.G466V, p.G469A, p.L597V, p.V600E); EGFR (p.G719C/S/A, p.T790M, p.L858R, p.L861Q, exon 19 deletions, exon 20 insertions); HER2 (exon 20 insertions); KRAS (all mutations in codons 12, 13, and 61); MEK (p.Q56P, p.K57N, p.D67N); NRAS (all mutations in codon 61); PIK3CA (p.E542K, p.E545K/Q, p.H1047R); PTEN (p.R233X); ALK. 

Please note: KRAS, along with others, is an emerging biomarkers in NSCLC (non-small cell lung cancer) and other tumor types. Currently, in NSCLC the KRAS G12C mutation is prevalent in approximately 13% of patients and represents nearly half (44%) of all KRAS mutations. Investigational agents targeting KRAS G12C are currently in clinical trials.
If you have any further questions, additional needs, or would like to speak with med fusion’s scientific staff, pathologists, or client services, please contact us at 972-966-7050/844-966-7050.


Transport Container
Paraffin embedded Tissue accompanied by a circled H & E slide indicating the area to be examined: submit in sterile biohazard plastic bag. Slides: submit 22 FFPE slides and H & E slide in slide holder. Specimen to be tested must contain a minimum of 20 percent tumor.

Transport Temperature
Paraffin embedded Tissue: Ambient or on ice pack in summer; Slides: Ambient.

Specimen Stability
Paraffin embedded tissue: Ambient: Indefinitely; Refrigerated: Indefinitely; Frozen: Unacceptable

Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Decalcified tissue specimen.

Next Generation Sequencing; Fluorescence in situ hybridization; Immunohistochemistry

Setup Schedule
LUNGSEQ Panel: Monday & Wednesday
FISH/IHC: Monday - Friday

Report Available
8-10 days

Laboratory test results should always be considered in the context of clinical observations. This test was developed and its performance characteristics determined by med fusion. It has not been cleared or approved by the U.S. Food and Drug Administration
(FDA). The FDA has determined that such clearance or approval is not necessary. This test is used for clinical purposes. It should not be regarded as investigational for research. This laboratory is certified under the Clinical Laboratory Improvement Amendments
of 1988 (CLIA) as qualified to perform high complexity clinical laboratory testing.

ALK gene rearrangement by FISH is an FDA approved test.

Reference Range
An interpretive report will be provided.

Clinical Significance
This test is intended to be used for the mutational profiling of tumors from patients with Non-Small-Cell Lung Cancer in order to help prioritize and direct treatment. It may be useful for patients who have become refractory to prior therapies and are searching for investigational targeted therapies offered in clinical trials or for newly diagnosed patients who would like to know their mutational profile to inform treatment options with approved targeted therapies or for the identification of potential future clinical trials or future approvals of targeted therapies.

Performing Laboratory
med fusion

The CPT Codes provided in this document are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge.