Friendswood, TX - 2018年7月30日., the skin cancer diagnostics company providing molecular diagnostics to improve cancer treatment decisions, today announced the presentation of new data showing that the DecisionDx®-Melanoma test improved risk prediction beyond that using American Joint Committee on Cancer (AJCC) based staging. The study was presented at the DERM2018 NP/PA CME Conference held in Las Vegas, Nevada.

The study assessed the impact on risk assessment for patients with Stage I-III melanoma when including results from the DecisionDx-Melanoma test along with population-based AJCC staging in a 690-patient cohort. The DecisionDx-Melanoma test uses tumor biology to provide an individual risk assessment for patients with melanoma. Results from this analysis showed that the addition of the test result to clinicopathologic AJCC staging significantly improved risk stratification. Technical reliability in over 17,000 clinical test orders was also assessed, and showed 98.3%报告肿瘤含量足够的样本成功.

研究结果:

  • Multivariate analysis demonstrated that the Class 2B result was an independent predictor of melanoma-specific survival (MSS) with a greater hazard ratio than using AJCC staging alone to determine risk.
  • Results from this multicenter study in 690 patients with Stage I-III melanoma show that the addition of DecisionDx-Melanoma testing can significantly improve risk prediction based on AJCC 8th edition staging alone, 并能更好地告知患者管理决策.
  • 单独使用AJCC分段, patients with Stage I melanoma have an estimated 98% MSS 5 years following diagnosis. 然而, patients in the Stage I melanoma group who had a Class 2B (highest risk) DecisionDx- Melanoma test result had an 89.5%的5年生存率,与IIB期疾病的风险估计相似.
  • 用于II期黑色素瘤患者, the DecisionDx-Melanoma test was able to further stratify patients from the AJCC-based 90% 5-year MSS into a low-risk (Class 1A) group with an MSS of greater than 99% (similar to Stage IA) and a Class 2B group with an MSS of 84.7%(类似第IIB/C阶段).
  • Using AJCC estimates alone, patients with Stage III melanoma have an MSS of 77% at 5 years. Use of the DecisionDx-Melanoma test enabled further stratification into a lower-risk Class 1A group with an MSS of 94.8% (similar to low-risk Stage IIA) and higher-risk Class 2B group with an MSS of 61.2%(类似第三阶段).

“准确的风险评估对临床决策非常重要. These results show that use of the DecisionDx-Melanoma test can further inform clinicopathologic staging and help guide patient management choices,费德里科说. 蒙松,M.D.他是城堡生物科学公司的首席医疗官. “公司orporating DecisionDx-Melanoma test results can drive improvements in follow-up and surveillance planning as well as sentinel lymph node biopsy discussions.”

研究细节:

  • ▪数据来自18u的皮肤黑色素瘤病例档案.S. 本研究采用了既往报道的队列研究(n=690, I-III期). I-II期病例按照AJCC第8版标准重新就诊. 重要的是, 第一阶段的5年MSS费率, II and III in this cohort were similar (within ±1%) to those reported for the AJCC 8th edition cohort.
  • ▪  Class 1A and 2B-predicted MSS outcomes for each stage were compared to 5-year MSS rates associated with AJCC 8th edition stage groups. 患者被分为二危组, I-IIA阶段为低风险,IIB-III阶段为高风险, based on National Comprehensive Cancer Network (NCCN) guidelines for surveillance and follow up.
  • ▪17个项目的技术成功,102 clinical DecisionDx-Melanoma orders received between July 2016 and April 2018, 其中96.3%有足够的肿瘤含量进行测试. decisionx黑素瘤测试达到了98分.肿瘤含量充足的样品技术成功率为3%.About DecisionDx-MelanomaThe DecisionDx-Melanoma test uses tumor biology to predict individual risk of melanoma recurrence and sentinel lymph node positivity independent of traditional factors. Using tissue from the primary melanoma, the test measures the expression of 31 genes. The test has been validated in three multi- center studies that have included 690 patients and have demonstrated consistent results. Performance has also been confirmed in four prospective studies including 702 patients. 这些研究证明了一致性的高性能和准确性, 哪个组合包含超过1,300名患者, provides confidence in disease management plans that incorporate DecisionDx-Melanoma test results.Prediction of the likelihood of sentinel lymph node positivity has also been validated in two prospective multicenter studies that included over 1,400名患者. Impact on patient management plans for one of every two patients tested has been demonstrated in multi-center and single-center studies. 更多关于检测和疾病的信息可以在www上找到.SkinMelanoma.com.关于城堡生物科学
    Castle Biosciences is a molecular diagnostics company dedicated to helping patients and their physicians make the best possible decisions about their treatment and follow up care based on the individual molecular signature of their tumor. 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),以及其他未得到充分服务的癌症的发展项目. 城堡生物科学公司的总部在友谊森林, 德州(休斯顿), 在凤凰城有实验室, 亚利桑那州. 更多信息请访问www.CastleBiosciences.com.

    DecisionDx-Melanoma, DecisionDx-CMSeq, DecisionDx-UM, decisionx - prame和DecisionDx- UMSeq是Castle Biosciences的商标, 公司. 任何其他商标是其各自所有者的财产.

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    Derek Maetzold,总裁兼首席执行官IR@castlebiosciences.com