MelaNodal Predict
Also known as: High risk, Prognostic, Predictive, Risk stratification, Metastasis prediction
Use
The MelaNodal Predict™ test is a laboratory‑developed test that predicts the risk of sentinel lymph node metastasis in SLNB‑eligible patients with cutaneous melanoma. It uses a quantitative reverse transcription polymerase chain reaction (qRT‑PCR) assay—based on the CP‑GEP (clinicopathologic‑gene expression profile) model—that integrates eight target genes (MLANA, GDF15, CXCL8, LOXL4, TGFBR1, ITGB3, PLAT, SERPINE2), two control genes (RPLP0, ACTB), patient age, and Breslow depth, applied to FFPE primary tumor tissue to stratify patients as low or high risk of nodal metastasis.
Special Instructions
A pathology report must accompany the FFPE tissue. Required clinical information includes specimen identifiers (case and block number), specimen site, processing details (routine or microwave), fixative type and fixation time/duration, pathologic diagnosis, mitotic rate, Breslow thickness, ulceration status, and T‑category. The test is processed weekly with set‑up on Tuesdays, Thursdays, and Saturdays.
Limitations
Results provide a probability‑based binary output (low‑risk vs high‑risk). Low‑risk corresponds to approximately 3% risk of nodal positivity; high‑risk corresponds to around 23.7% risk. Its use should align with current NCCN recommendations regarding SLNB. The model has been clinically validated in over 4,700 patients and across institutions, with long‑term outcomes like recurrence‑free survival, distant metastasis‑free survival, and overall survival reported; however, it is intended for patients ≥18 years with newly diagnosed invasive cutaneous melanoma being considered for SLNB.
Methodology
PCR-based (qRT-PCR)
Biomarkers
Result Turnaround Time
3-5 days
Related Documents
For more information, please review the documents below
Specimen
Tissue (FFPE)
Volume
Not provided
Minimum Volume
Not provided
Container
FFPE tissue block or 5 slides (minimum 3) 10 microns each (10 slides of 4‑6 microns acceptable) and 1 H&E section
Collection Instructions
Do not freeze. Send at room temperature or cooled (4 °C)
Stability Requirements
| Temperature | Period |
|---|---|
| Room Temperature | Preferred |
| Refrigerated | Acceptable |
| Frozen | Unacceptable |