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LUNGSEQ Panel : 1015162
MessagePlease provide most recent Pathology report.
Test Code
MDFCPNGSLAPA or 1015162
Alias/See Also
LungSEQ; Non Small Cell Lung Cancer; LungSEQ by NGS; KRAS; KRAS G12C; G12C
CPT Codes
81445
Includes
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.
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.
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 10 FFPE slides and H & E slide in slide holder. Specimen to be tested must contain a minimum of 10 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.
Methodology
Next Generation Sequencing
Setup Schedule
Monday & Wednesday
Report Available
8-10 days
Limitations
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.
(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.
Reference Range
An interpretive report will be provided.
Clinical Significance
This test is intended to be used for the molecular genotyping of tumors from patients with Non-Small-Cell Lung Cancer in order to help prioritize treatment.
Performing Laboratory
med fusion
