FRIENDSWOOD, Texas–(BUSINESS WIRE)– Castle Biosciences, Inc., 一家皮肤癌诊断公司,提供个性化的基因组信息,以改善癌症管理决策, today announced publication of data supporting clinical use of the DecisionDx®-Melanoma test to inform decisions for use of sentinel lymph node biopsy (SLNB), a surgical procedure used to help stage melanoma. 该研究发现,decisionx -黑色素瘤检测结果可以与临床病理因素一起使用,为患者讨论和建议SLNB符合国家黑色素瘤临床实践指南. The study was published in Future Oncology.

Key Study Findings:

  • 国家指南推荐SLNB外科手术来评估肿瘤特征至少有5%前哨淋巴结(SLN)阳性可能性的黑色素瘤患者的预后. 由于手术的假阴性率,如果患者SLN阳性的可能性小于5%,指南一般不推荐该手术, associated complication risks and cost.
  • This study was designed to determine if the DecisionDx-Melanoma 31-gene expression profile (GEP) test could help identify patients with a low risk of SLN positivity (<5%) and validate this intended use.
  • 预测模型显示,decisionx -黑色素瘤试验结合肿瘤深度(T分类)和患者年龄可以预测SLN阳性, and this strategy was validated in two independent, prospective, multicenter cohorts totaling 1,421 patients. Patients had a median age of 63 years, median Breslow depth of 1.16 millimeters and 21.4% had ulceration present.
  • For patients with T1-T2 tumors (≤2.0 millimeters in depth) and a Class 1A test result (lowest risk of recurrence), the risk of SLN positivity was 4.6%. For the subgroup of patients who were 55 years or older the risk decreased to 2.8% and 1.6% for those 65 years or older. 对于SLN阳性风险低于5%的患者,指南一般不建议进行SLNB手术.
  • 所有年龄的T1-T2肿瘤患者,检查结果为2B级(复发风险最高), the risk of SLN positivity was 18.8%. 指南建议对于SLN阳性风险超过10%的患者应给予SLNB手术治疗.
  • 评估1A类患者因阳性结果可能性低而不接受SLNB手术治疗的临床结果, a retrospective dataset of 690 patients with long-term follow-up was used. Importantly, at 5 years, Class 1A patients with T1-T2 tumors had a melanoma-specific survival rate of 99.6%, overall survival rate of 98.2%, and distant metastasis-free survival rate of 95.3%.

“The GEP test result, along with tumor thickness and patient age, 可以帮助确定一组黑色素瘤患者谁可能避免SLNB程序基于国家临床黑色素瘤指南,” said the study lead author John Vetto, M.D., Professor of Surgery, 外科肿瘤科和外科皮肤肿瘤科主任, Oregon Health & Science University. “为医生提供准确的风险信息,以便更好地告知患者SLNB选择是黑色素瘤治疗的一个重要进展, which can help us better direct resources to patients that really need them.”

The full published study results can be accessed at the Future Oncology website.

Sentinel Lymph Node Biopsy Background

SLNB是一种评估皮肤黑色素瘤患者预后的外科手术. 该程序提供了预后信息,并可以确定辅助治疗的资格, but can be associated with complications, adding a significant economic burden to the healthcare system.

目前的指南建议临床医生讨论和/或为SLNB阳性可能性为5%或更高的患者提供SLNB手术, 如果患者SLN阳性的可能性小于5%,则不推荐该手术. For patients who are SLNB eligible, decisiondx -黑色素瘤试验可以通过识别一组低风险肿瘤生物学的患者,这些患者SLN阳性的可能性小于5%,从而告知SLNB的决策, and thus can safely avoid the procedure.

About DecisionDx-Melanoma

decisiondx -黑素瘤试验使用肿瘤生物学来预测个体黑素瘤复发风险和前哨淋巴结阳性,不受传统因素的影响,900 patients. 该测试使用原发性黑色素瘤的组织,测量31个基因的表达. 该测试已经在三个多中心研究中得到了验证,包括690名患者,并得到了一致的结果. 在包括780名患者在内的5项前瞻性研究中也证实了这一表现. The consistent high performance and accuracy demonstrated in these studies, which combined have included over 1,470 patients, 对纳入decisionx -黑色素瘤检测结果的疾病管理计划提供信心.

前哨淋巴结阳性可能性的预测也在两个前瞻性多中心队列(包括1个以上)中得到验证,400 patients. 在多中心和单中心研究中,每两个接受检测的患者中就有一个对患者管理计划产生影响. More information about the test and disease can be found at www.SkinMelanoma.com.

About Castle Biosciences

Castle Biosciences是一家皮肤癌诊断公司,致力于帮助患者和他们的医生根据患者肿瘤的个体分子特征对治疗和后续护理做出更明智的决定. The Company currently offers tests for patients with cutaneous melanoma (DecisionDx®-Melanoma, DecisionDx®-CMSeq; www.SkinMelanoma.com) and uveal melanoma (DecisionDx®-UM, DecisionDx®-PRAME and DecisionDx®-UMSeq; www.MyUvealMelanoma.com), with programs in development for other underserved cancers, 其中最先进的是皮肤鳞状细胞癌患者. Castle Biosciences is based in Friendswood, Texas (Houston), and has laboratory operations in Phoenix, Arizona. More information can be found at www.CastleBiosciences.com.

DecisionDx-Melanoma, DecisionDx-CMSeq, DecisionDx-UM, DecisionDx-PRAME and DecisionDx-UMSeq are the trademarks of Castle Biosciences, Inc. Any other trademarks are the property of their respective owners.

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Contacts

Derek Maetzold, President and CEO

IR@castlebiosciences.com

 

Source: Castle Biosciences, Inc.