Comprehensive LungSEQPlus Panel : 1016995

Message
Please provide most recent Pathology report.


Test Code
MDFCPNGS50LP or 106995


Alias/See Also
LungSeq; Non Small Cell Lung Cancer; LungSeq by NGS, TMB, PD-L1, MET


CPT Codes
81445, 88271x2, 88275, 88360, 81449

Includes
LUNGSEQ PLUS Panel Components: PDL1; MET by FISH; AKT1; ALK; APC; ATM; BRAF; CDH1; CDKN2A; CSF1R; CTNNB1; EGFR; ERBB2; ERBB4; ESR1; FBXW7; FGFR1; FGFR2; FGFR3; FLT3; GNA11; GNAQ; GNAS; HNF1A; HRAS; IDH1; IDH2; JAK2; JAK3; KDR; KIT; KRAS; MAPD2K1; MET; MLH1; NOTCH1; NRAS; PDGFRA; PIK3CA; PIK3R1; PTEN; PTPN11; RB1; RET; ROS1; SMAD4; SMARCB1; SMO; SRC; STK11; TP53; VHL; TMB; ALK fusion; NTRK 1,2,3 fusion; RET fusion; ROS1 fusion; METex14 skip


Instructions
Tissue.


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 24 FFPE slides and 1 H & E slide (or one additonal slide) in slide holder.   Specimen to be tested must contain a minimum of 10 percent tumor.


Transport Temperature
Paraffin embedded Tissue: Room temperature or on ice pack in summer; Slides: Room temperature


Specimen Stability
Paraffin embedded tissue: Room temperature: Indefinitely; Refrigerated: Indefinitely; Frozen: Unacceptable


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


Methodology
Next Generation Sequencing; Fluorescence in situ hybridization; Immunohistochemistry

Setup Schedule
Tuesday


Report Available
10-14 days


Limitations
This test was developed and its analytical performance
characteristics have been determined by medfusion. It has
not been cleared or approved by the US Food and Drug
Administration. This assay has been validated pursuant to
the CLIA regulation and is used for Clinical purposes.


Reference Range
An interpretive report will be provided.


Clinical Significance
The Comprehensive LungSEQPlus panel is intended to be used for the detection of somatic alterations within clinically relevant genes in order to help predict response to targeted therapies and prioritize treatment for patients with non-small cell lung cancer. All results should be interpreted in conjunction with other clinical and pathological findings.


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.