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50SEQ with MSI Panel : 1004874
MessagePlease provide most recent Pathology report.
Test Code
MDFCPNGS50P or 1004874
Alias/See Also
50SEQ by NGS, KRAS, KRAS G12C, G12C
CPT Codes
81457
Includes
50SEQ Panel Components: AKT1, ALK, APC, ATM, BRAF, CDH1, CDKN2A, CSF1R, CTNNB1, EGFR, ERBB2(HER2), ERBB4, ESR1, FBXW7, FGFR1, FGFR2, FGFR3, FLT3, GNA11, GNAQ, GNAS, HNF1A, HRAS, IDH1, IDH2, JAK2, JAK3, KDR, KIT, KRAS, MAP2K1, MET, MLH1, NOTCH1, NRAS, PDGFRA, PIK3CA, PIK3R1, PTEN, PTPN11, RB1, RET, ROS1, SMAD4, SMARCB1, SMO, SRC, STK11, TP53, VHL, and Microsatellite Instability (MSI) by PCR.
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 16 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 and Polymerase Chain Reaction (PCR)
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
The 50-gene solid tumor panel (50SEQ) is intended to aid the oncologist in developing a treatment plan for patients with refractory and rare tumors in situations where standard of care therapies have failed, or no standard of care exists for the disease.
Performing Laboratory
med fusion
