The Merlin Test  (CP-GEP) Accurately Stratifies Cutaneous Melanoma Patients as Low Risk or High Risk for Sentinel Lymph Node Metastases Impacting Clinical Decision Making

梅林试验（CP-GEP）准确地将皮肤黑色素瘤患者分为前哨淋巴结转移影响临床决策的低风险或高风险

Merlin test  (CP-GEP) [1] successfully stratifies T1a melanoma patients considered for sentinel lymph node biopsy (SLNB) by their care providers, reducing SLNB surgeries by 87.6% with a negative predictive value (NPV) of 98.5%.

梅林试验（CP-GEP）[1]成功地将T1a黑色素瘤患者的护理人员考虑进行前哨淋巴结活检（SLNB），SLNB手术减少87.6%，阴性预测值（NPV）为98.5%。

Merlin test  (CP-GEP) identifies high-risk T1a melanoma patients for SLNB surgery, even those who might be missed due to the absence of conventional adverse features, offering a more precise and individualized approach to managing early-stage melanoma.

Merlin测试（CP-GEP）可识别高危T1a黑色素瘤患者进行SLNB手术，即使是那些由于缺乏常规不良特征而可能被遗漏的患者，也为早期黑色素瘤的治疗提供了更精确和个性化的方法。

ROTTERDAM, Netherlands and SAN DIEGO, Oct. 11, 2024 /PRNewswire/ -- SkylineDx, an innovative diagnostics company specializing in the research and development of molecular diagnostics for oncology, inflammatory, and infectious diseases today announced that new clinical data on the efficacy of its Merlin test will be presented at the 21st International Congress of the Society for Melanoma Research (SMR) Annual Meeting 2024 in New Orleans [2]..

。。

The study, which assessed the clinical utility and performance of Merlin test in T1a melanoma patients, showed that it dramatically improves the ability to differentiate between low- and high-risk T1a patients. Merlin test identified 88% of patients as Low Risk, resulting in a post-test SLN positivity rate of only 1.5% among those classified as Merlin Low Risk.

这项研究评估了梅林试验在T1a黑色素瘤患者中的临床效用和表现，结果表明，它显着提高了区分低风险和高风险T1a患者的能力。。

Conversely, 12% of patients were classified as High Risk, with a significantly higher SLN positivity rate of 15.8% among those identified as Merlin test High Risk. These findings highlight the test's potential to reduce unnecessary SLNB surgeries, preventing overtreatment in the vast majority of patients while ensuring high-risk individuals receive appropriate care..

相反，12%的患者被归类为高风险，在被确定为梅林试验高风险的患者中，SLN阳性率显着高于15.8%。。。

Alexander Meves, M.D., MBA, dermatologist at Mayo Clinic and principal inventor of the CP-GEP model, shared: 'The intent is to help prevent undertreatment in seemingly low-risk early-stage melanoma patients who are actually at risk for nodal metastasis. By accurately identifying these at-risk individuals, we ensure that they receive the necessary interventions, even in the absence of traditional clinical risk factors.'.

梅奥诊所皮肤科医生、CP-GEP模型的主要发明者、医学博士亚历山大·梅维斯（AlexanderMeves）分享道：“目的是帮助预防看似低风险的早期黑色素瘤患者的治疗不足，这些患者实际上有淋巴结转移的风险。通过准确识别这些高危人群，我们确保他们即使在没有传统临床风险因素的情况下也能接受必要的干预。”。

For patients with at least one traditional adverse feature, such as age under 40, lymph vascular invasion, or a high mitotic rate, Merlin test identified 37 patients as Low Risk, all with a post-test SLN positivity rate of 0%. Additionally, among 104 patients without any adverse features, the Merlin test still identified 7 patients as High Risk, with a post-test SLN positivity rate of 14.3%.

。此外，在104例没有任何不良特征的患者中，梅林试验仍将7例患者确定为高危患者，试验后SLN阳性率为14.3%。

These results demonstrate that Merlin test effectively pinpoints high-risk individuals who might otherwise go untreated under traditional guidelines..

这些结果表明，梅林测试有效地确定了高危人群，否则他们可能会在传统指导下未经治疗。。

This latest data highlights the importance of Merlin test in transforming early-stage melanoma treatment. Merlin test provides clinicians with a robust, evidence-based tool to tailor SLNB surgery decisions, minimizing unnecessary surgeries while ensuring that high-risk patients receive appropriate care.

这项最新数据强调了梅林试验在转化早期黑色素瘤治疗中的重要性。Merlin测试为临床医生提供了一种强大的循证工具，可以定制SLNB手术决策，最大程度地减少不必要的手术，同时确保高危患者得到适当的护理。

With the ongoing advancements in genomic testing and personalized medicine, the Merlin test offers a new standard of care that has the potential to improve outcomes for countless melanoma patients..

随着基因组测试和个性化医学的不断进步，梅林测试提供了一种新的护理标准，有可能改善无数黑色素瘤患者的预后。。

About CP-GEP (Merlin test)

关于CP-GEP（梅林测试）

CP-GEP is a non-invasive prediction model for cutaneous melanoma patients that combines clinicopathologic (CP) variables with gene expression profiling (GEP). This model is able to stratify patients based on being high or low risk for metastasis and thereby categorize them in the appropriate surgical action categories listed in evidence-based cancer treatment, prevention and screening guidelines. The CP-GEP model was developed by Mayo Clinic and SkylineDx BV and it has been clinically validated in multiple studies.

CP-GEP是一种针对皮肤黑色素瘤患者的非侵入性预测模型，它将临床病理（CP）变量与基因表达谱（GEP）相结合。该模型能够根据转移风险的高低对患者进行分层，从而将其分类为循证癌症治疗，预防和筛查指南中列出的适当手术类别。CP-GEP模型由Mayo Clinic和SkylineDx BV开发，并已在多项研究中进行了临床验证。

More information (including references) may be obtained at www.falconprogram.com and www.merlinmelanomatest.com. The test has been launched in the United States and Europe as Merlin test. SkylineDx collaborates with diagnostic service providers globally to bring this test to market and increase access.

有关更多信息（包括参考资料），请访问www.falconprogram.com和www.merlinmelanomatest.com。该测试已作为Merlin测试在美国和欧洲启动。SkylineDx与全球诊断服务提供商合作，将该测试推向市场并增加访问。

In the United States, Tempus is commercializing the Tempus Merlin test.Quest Diagnostics launched their own LDT version of the CP-GEP model in the United States under the brand name MelaNodal Predict™.About SkylineDx.

在美国，Tempus正在将Tempus Merlin测试商业化。Quest Diagnostics在美国推出了自己的LDT版本的CP-GEP模型，品牌名为MelaNodal Predict™。关于SkylineDx。

SkylineDx is a biotechnology company focused on research & development of molecular diagnostics in oncology, inflammatory, and infectious diseases. 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.

。SkylineDx利用其专业知识弥合了学术上发现的基因表达特征与具有高临床实用性的市售诊断产品之间的差距，帮助医疗保健专业人员准确确定疾病的类型或状态或预测患者对治疗的反应。

Based on test results, healthcare professionals can tailor the treatment approach to the individual patient. SkylineDx is headquartered in Rotterdam, the Netherlands, complemented by a U.S. base of operations and a CAP/CLIA certified laboratory in San Diego, California, USA. To learn more about SkylineDx, please visit www.skylinedx.com..

根据测试结果，医疗保健专业人员可以为患者量身定制治疗方法。SkylineDx总部位于荷兰鹿特丹，并在美国加利福尼亚州圣地亚哥设有美国运营基地和CAP/CLIA认证实验室。要了解SkylineDx的更多信息，请访问www.SkylineDx.com。。

Footnotes:

脚注：

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

Bellomo等人，结合肿瘤分子和临床病理危险因素的模型预测原发性皮肤黑色素瘤的前哨淋巴结转移。JCO精准肿瘤学（2020）。（笑声）https://doi.org/10.1200/PO.19.00206

Yu et al. CP-GEP Identifies T1a Melanoma Patients at Risk of Sentinel Lymph Node Metastasis.  https://falconprogram.com/files/SMR%202024%20T1a.pdf

Yu等人，CP-GEP确定T1a黑色素瘤患者有前哨淋巴结转移的风险。（笑声）https://falconprogram.com/files/SMR%202024%20T1a.pdf

SOURCE SkylineDx

源SkylineDx

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