COLONSEQ Panel : 1004878

Message
Please provide most recent Pathology report.


Test Code
MDFCPNGSCC1P or 1004878


Alias/See Also
ColonSEQ by NGS


CPT Codes
81457

Includes
COLONSEQ Panel Components: BRAF (p.V600E); KRAS (p.G12C/S/R/V/A/D, p.G13C/S/R/D/A, p.Q61R/K/L/H, p.K117N, p.A146T/P/V); NRAS (p.G12C/S/A/D/V, p.G13R/C/D/V, p.Q61K/L/R); PIK3CA (p.E542K, p.E545K/Q/A/G/V, p.Q546K/E/P/R/L, p.H1047R/L); PTEN (p.R233X), and Microsatellite Instability (MSI) by PCR.
   
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 15 FFPE slides and 1 H & E slide (or one additional 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 PCR (MSI)

Setup Schedule
Monday & Thursday


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.


Reference Range
An interpretive report will be provided.


Clinical Significance
This test is intended to be used as a disease specific solid tumor panel to aid the oncologist in prioritizing standard of care therapy choices for their patients with Colorectal Cancer.


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.