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MelaNodal Predict
Test Code13222
CPT Codes
81599<br>This test is not available for New York patient testing
Preferred Specimen
Formalin-fixed paraffin-embedded tissue block, or 5 (10-micron) slides
Minimum Volume
3 (10 micron) slides • 10 (4-6 micron) slides
Other Acceptable Specimens
10 (4-6)-micron slides
Instructions
Do not Freeze. Do not Reject. Send to lab for testing assessment.
Pathology report must accompany paraffin block or slides. Information required in this report includes: Physician identification, specimen identifiers (case and block number), specimen site and type, tissue processing used (routine or microwave), type of fixative, time and duration of fixation, pathologic diagnosis, mitotic rate, Breslow thickness, Ulceration status, and T-category.
Pathology report must accompany paraffin block or slides. Information required in this report includes: Physician identification, specimen identifiers (case and block number), specimen site and type, tissue processing used (routine or microwave), type of fixative, time and duration of fixation, pathologic diagnosis, mitotic rate, Breslow thickness, Ulceration status, and T-category.
Transport Temperature
Room temperature
Specimen Stability
Room temperature: Preferred
Refrigerated: Acceptable
Frozen: Unacceptable
Refrigerated: Acceptable
Frozen: Unacceptable
Methodology
Polymerase Chain Reaction (PCR)
FDA Status
This test was developed and its analytical performance characteristics have been determined by Quest Diagnostics. It has not been cleared or approved by FDA. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.
Setup Schedule
Set up: Tues, Thurs, Sat; Report available: 4-5 days
Reference Range
See Laboratory Report
Clinical Significance
The MelaNodal Predict assay is a quantitative reverse transcription polymerase chain reaction (qRT-PCR) assay based upon the CP-GEP (clinicopathologic and gene expression profile) model that combines the gene expression of 8 target genes (MLANA, GDF15, CXCL8, LOXL4, TGFBR1, ITGB3, PLAT, SERPINE2) and two control genes (RLP0 and ACTB) with the clinicopathological features of patient age and Breslow depth to predict a cutaneous melanoma patient's risk of sentinel lymph node mestastasis from fomalin-fixed, paraffin-embedded primary tumor tissue obtained from those who are being considered for the sentinel lymph node biopsy procedure (SLNB) in accordance with current recommended SLNB eligibility to identify patients who may safely forgo the SLNB procedure due to a low risk of nodal metastasis.
