SkylineDx announces Medicare coverage for its predictive melanoma assay Merlin™ Test

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May 25, 2022, 08:45 ET

ROTTERDAM, Netherlands and SAN DIEGO, May 25, 2022 /PRNewswire/ -- Today, 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.

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."

About Merlin Test

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).

About SkylineDx

SkylineDx is a biotechnology company focused on research & development of molecular diagnostics in oncology and inflammatory diseases. The company is headquartered in Rotterdam (the Netherlands) and complemented with a commercial team, a field medical and scientific affairs team and a CAP/CLIA certified laboratory in San Diego (CA, USA). SkylineDx uses its expertise to bridge the gap between academically discovered gene expression signatures and commercially available diagnostic products with high clinical utility, assisting healthcare professionals in accurately determining the type or status of disease or predicting a patient's response to treatment. Based on test results, healthcare professionals can tailor the treatment approach to the individual patient. To learn more about SkylineDx, please visit www.skylinedx.com.

Footnotes

Link to this press release on website SkylineDx (click here).
Foundational policy "Melanoma Risk Stratification Molecular Testing" (link to policy).
Bellomo et al., Model combining tumor molecular and clinicopathologic risk factors predicts sentinel lymph node metastasis in primary cutaneous melanoma. JCO Precision Oncology (2020). https://doi.org/10.1200/PO.19.00206.

SOURCE SkylineDx