SkylineDx, a leading molecular diagnostics company, announces Medicare coverage for Merlin Test. The local coverage determination was issued under the foundational policy “Melanoma Risk Stratification Molecular Testing”, by the Medicare Administrative Contractor Palmetto GBA through its Molecular Diagnostic Service Program (MolDX)2. This coverage provides Medicare reimbursement for Merlin Test in cutaneous melanoma (skin cancer, thickness T1b-T2) patients for which additional guidance may augment and inform clinical management decisions by physicians considering the surgical Sentinel Lymph Node Biopsy (SLNB) procedure.
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Merlin Test helps identify melanoma patients who are at low risk for nodal metastasis and may safely forgo SLNB surgery. SLNB is an invasive surgical procedure used to determine metastatic spread of the cancer for staging purposes. In approximately 80% of the surgeries, the biopsy comes back negative for metastasis and does not further impact the patient pathway. The test provides a more personalized insight on the metastatic propensity of the tumor; patients with a low-risk tumor could avoid the surgery3.
“Medicare coverage for Merlin Test marks a significant achievement and is a critical step in helping melanoma patients gain access to this innovative molecular test, that on the basis of their personal risk profile, may directly impact and further improve their care,” comments Dharminder Chahal, CEO SkylineDx. “We commend MolDX for this acknowledgement in our efforts to personalize cancer care.”
Merlin Test uses the CP-GEP model, a powerful proprietary algorithm that calculates the risk of metastasis in a patient’s sentinel lymph nodes3. The model is able to calculate risk on an individual basis through a combination analysis of 8 genes from the patient’s primary tumor, the tumor thickness and the patient’s age; and has been analytically and clinically validated. Further clinical research and validation studies on the predictive use of the CP-GEP model is the main focus of Merlin Study Initiative, developed under the wings of Falcon R&D Program. More information (including references) may be obtained at www.falconprogram.com. Merlin Test is commercially available in the United States as a Laboratory Developed Test serviced from SkylineDx’s CAP/CLIA laboratory in San Diego (CA).