{"id":104,"date":"2021-09-02T20:00:49","date_gmt":"2021-09-03T03:00:49","guid":{"rendered":"https:\/\/merlinmelanoma.flywheelstaging.com\/?page_id=104"},"modified":"2026-03-30T12:53:11","modified_gmt":"2026-03-30T19:53:11","slug":"physicians","status":"publish","type":"page","link":"https:\/\/merlinmelanomatest.com\/global\/physicians\/","title":{"rendered":"Physicians"},"content":{"rendered":"

\"Merlin<\/span><\/div><\/div><\/div>
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Can my patient forgo the sentinel lymph node biopsy?<\/h1><\/div><\/div><\/div>
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The Merlin Assay addresses this clinical unmet need by triaging cutaneous melanoma patients for sentinel lymph node biopsy based on their risk for nodal metastasis.<\/h1>\n<\/div><\/div><\/div>

Merlin Assay at a glance<\/strong><\/h2><\/div>
<\/div>
\"Merlin<\/div>

Gene expression-based test to identify primary cutaneous melanoma patients who are at low risk of nodal metastasis and may therefore avoid the sentinel lymph node biopsy (SLNB).<\/h2><\/div><\/div><\/div>
\"Merlin<\/div>

Enhances clinicopathologic findings with critical tumor biology insights.<\/h2><\/div><\/div><\/div>
\"Merlin<\/div>

Improved performance over clinicopathologic (CP) variables only (e.g. nomograms like MIA and MSKCC6<\/sup>) for appropriately predicting SLN status.7<\/sup><\/h2><\/div><\/div><\/div>
\"Merlin<\/div>

Validated in multiple multicenter clinical trials in the U.S. and EU.<\/h2><\/div><\/div><\/div>
\"Merlin<\/div>

Non-invasive test that uses primary biopsy tissue.<\/h2><\/div><\/div><\/div>
\"Merlin<\/div>

Developed by SkylineDx in collaboration with the Mayo Clinic.<\/h2><\/div><\/div><\/div>
<\/div><\/div><\/div><\/div><\/div><\/div>

The test identifies primary cutaneous melanoma patients at low risk for nodal metastasis who may therefore forgo a sentinel lymph node biopsy procedure<\/strong><\/h2><\/div><\/div><\/div><\/div><\/div>
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T1-T2 melanomas account for ~86% of the newly diagnosed melanomas. For this group of patients, guidelines recommend to \u201cdiscuss and consider\/offer\u201d the SLNB surgery.1<\/sup><\/p>\n<\/div><\/div><\/div><\/div><\/div>

Merlin provides unique insights on the aggressiveness of your patient\u2019s melanoma<\/strong><\/h2><\/div>

Current treatment decisions are made based on clinicopathologic factors such as patient\u2019s age, Breslow thickness, ulceration. However, these variables do not always provide a complete view of your patient\u2019s melanoma and the individual corresponding risks.<\/p>\n

With the Merlin Assay, you can gain a deeper understanding of your patient\u2019s cancer with no additional procedure required.<\/p>\n

The Merlin Assay uses the CP-GEP model, an algorithm developed by logistic regression modeling. The combination of clinicopathologic factors \u2013 patient\u2019s age and Breslow thickness \u2013 with the gene expression profiling component of 8 specific genes involved in cancer metastasis and melanosome biogenesis, will allow you to better understand your patient\u2019s risk and may optimize a personalized treatment plan.<\/p>\n<\/div>

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The Merlin Assay supports your decision-making<\/strong><\/h2><\/div>

The Merlin Assay may help you optimize the clinical management of each patient. Validation studies in the United States and Europe confirm that the test accurately identifies patients who have a low risk for nodal metastasis. The test provides a binary result:<\/p>\n<\/div>

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The Merlin Assay has a rapid turnaround time, and makes use of the biopsy tissue collected for diagnosis.<\/strong><\/p>\n<\/div><\/div><\/div><\/div><\/div>

Low Risk Report<\/strong><\/h3><\/div>
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High Risk Report<\/strong><\/h3><\/div>
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Merlin may reduce the number of SLNB-related complications by 59% if Merlin Low Risk patients would forgo the SLNB surgery5<\/sup><\/strong><\/h2><\/div><\/div><\/div><\/div><\/div>
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Tissue requirements<\/strong><\/h2><\/div>
    \n
  • 5 x 10 microns formalin fixed and paraffin embedded (FFPE) tissue of primary cutaneous melanoma biopsy.<\/li>\n
  • No macrodissection is needed.<\/li>\n<\/ul>\n<\/div>
    <\/div>
    <\/div><\/div><\/div>

    The Merlin Assay is now available as CE-IVD product in Europe. Soon to be available also on Idylla\u2122<\/sup> platform8<\/sup>.<\/strong><\/h2><\/div><\/div><\/div>

    Merlin Assay indication<\/strong><\/h3><\/div>

    Utility<\/strong><\/h4><\/div>

    Identify primary cutaneous melanoma patients who have a low risk for nodal metastasis and may forgo sentinel lymph node biopsy.<\/p>\n<\/div>

    Intended use population<\/strong><\/h4><\/div>

    SLNB eligible patients:<\/span><\/h4><\/div>
    \"\"<\/div>

    Newly diagnosed invasive malignant melanoma of the skin (AJCC 8th edition staging guidelines)<\/h2><\/div><\/div><\/div>
    \"\"<\/div>

    Without clinical evidence of nodal involvement or distant metastasis (cN0M0)<\/h2><\/div><\/div><\/div>
    \"\"<\/div>

    pT1-pT3 melanomas<\/h2><\/div><\/div><\/div>
    <\/div><\/div><\/div><\/div>
    <\/div>
      \n
    1. NCCN Guidelines 2022 version 1<\/li>\n
    2. Moody JA, Ali RF, Carbone AC, et al: Complications of sentinel lymph node biopsy for melanoma – A systematic review of the literature. Eur J Surg Oncol 43:270-277, 2017<\/li>\n
    3. Morton DL, Thompson JF, Cochran AJ, et al: Final trial report of sentinel-node biopsy versus nodal observation in melanoma. N Engl J Med 370:599-609, 2014<\/li>\n
    4. Shaikh WR, Dusza SW, Weinstock MA, et al: Melanoma Thickness and Survival Trends in the United States, 1989-2009. J Natl Cancer Inst. 2016<\/li>\n
    5. Hieken, T.J., Sadurn\u00ed, M.B., Quattrocchi, et al: Using the Merlin assay for reducing sentinel lymph node biopsy complications in melanoma: a retrospective cohort study. Int J Dermatol. 2022<\/li>\n
    6. Johansson I, Tempel D, Dwarkasing D, et al. Validation of a clinicopathological and gene expression profile model to identify patients with cutaneous melanoma where sentinel lymph node biopsy is unnecessary. EJSO. 2021: DOI 10.1016\/j. ejso.2021.11.010.<\/li>\n
    7. Bellomo D, Arias-Mejias S, Ramana C, et al. A model combining tumor molecular and clinicopathologic risk factors predicts sentinel lymph node metastasis in primary cutaneous melanoma. JCO Precis Oncol. 2020:DOI 10.1200\/PO.19.00206.<\/li>\n<\/ol>\n<\/div><\/div><\/div><\/div><\/div><\/p>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"open","template":"100-width.php","meta":{"footnotes":"","_links_to":"","_links_to_target":""},"class_list":["post-104","page","type-page","status-publish","hentry"],"yoast_head":"\nMerlin Melanoma<\/title>\n<meta name=\"description\" content=\"Merlin is a powerful tool in personalized melanoma care.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/merlinmelanomatest.com\/global\/physicians\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Merlin Melanoma\" \/>\n<meta property=\"og:description\" content=\"Merlin 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