生物标志物发现Companion Diagnostic—an end-to-end approach to precision medicine
博188金宝基础医学is dedicated to working throughout the entire process to help produce results for biopharma partners, physicians, and patients alike. We are also dedicated to researching and publishing throughout the entire development and commercialization of companion diagnostic claims. Explore a timeline of our documented progress of one such claim below.
FoundationOne CDx was approved to identify mutations that lead to遇见exon 14 skipping in advanced non-small cell lung cancer (NSCLC) and match patients with a new targeted therapy, which was approved in parallel. This simultaneous approval presents a new treatment option for the 2-3% of lung cancer patients with cancers driven by遇见ex14。这是肺癌治疗进展路径的另一个重要一步，这表明了癌症精密医学在行动中的力量和综合基因组分析扮演的作用。
The first FoundationOne®* report on splice alterations was published.
博188金宝基础医学identified a statistical signal for a遇见splice variant enriched in NSCLC, elevated遇见exon 14 (遇见ex14) splice variants to the front page of the FoundationOne® report and associated them with crizotinib.
We performed outreach to physicians for recent patients whose Foundation Medicine reports showed遇见ex14 alterations.
博188金宝基础医学发表于景观遇见ex14 alterations (with Novartis co-authors), including case reports demonstrating response to crizotinib and capmatinib.1
Data mining revealed that variants affecting splicing of the遇见基因在肺癌中比任何其他肿瘤类型更频繁地发生。
After examining all genomic alterations in our database, results indicated that遇见ex14突变在临床上和治疗相关的致癌司机〜3％的NSCLC样品中。2
我们发表了这些发现2015年，那年呈现在ASCO, creating broader interest in the role of遇见ex14 mutations in lung cancer.2
Development of a targeted therapy for遇见ex14 skipping mutations progresses with Novartis-sponsored clinical trials; Foundation Medicine partners to define biomarker and develop CDx.
5月6日，2020年FoundationOne®CDx is FDA-approved as the companion diagnostic test for TABRECTA™ (capmatinib), the first targeted therapy for mutations that lead to遇见ex14跳过。
The GEOMETRY-mono 1 trial has demonstrated that patients with advanced NSCLC, who harbor mutations that lead to遇见用Capmatinib治疗的EX14跳跃，在治疗 - 诺芬组和预处理组中，对整体反应率（ORR）的显着改善。4
FoundationOne CDx, the first FDA-approved comprehensive genomic profiling (CGP) test for all solid tumors with Medicare coverage for qualifying patients†，是Tabrecta的第一个且唯一的FDA批准的伴随诊断测试™（Capmatinib），批准用于局部晚期或转移性非小细胞肺癌（NSCLC）患者批准的激酶抑制剂，患者患有这些突变。
Reports—Following approval, FoundationOne CDx reports began including these therapies on page 1 in accordance with the associated FDA-approved indications.
Outreach—如果在过去24个月内收到基础CDX组织的测试的至少一个患者，我们通知了医生，以确定导致的突变遇见ex14 skipping, and thus, may meet the eligibility criteria for treatment with capmatinib.
1Jenkins Rw，Oxnard Gr，Elkin S，Sullivan Ek，Carter JL，Barbie Da。患有肺腺癌患者患者患有患者的患者的反应。2015年2月7日临床肺癌。
2Frampton gm。先进癌症的综合基因组分析（CGP），以确定达到达到抑制剂敏感性的改变的变化。J Clin Oncol 2015; 33（SCHILE; Abst 11007）
3Schrock, Alexa B. et al. Characterization of 298 Patients with Lung Cancer Harboring MET Exon 14 Skipping Alterations. J Thorac Oncol. 2016 Sep;11(9):1493-502.
4Wolf J, Seto T, Han J, et al. Capmatinib in METex14-mutated advanced non-small cell lung cancer (NSCLC): Efficacy data from the phase II GEOMETRY mono-1 study. Abstract 9004. Presented at: 2019 ASCO Annual Meeting; May 31-June 4, 2019; Chicago, IL
*FoundationOne CDx is the next evolution of FoundationOne, our pioneering laboratory-developed test (LDT). FoundationOne CDx is approved by the FDA. FoundationOne is performed in our CLIA-certified and CAP-accredited laboratory.
†Medicare and Medicare Advantage members have coverage of FoundationOne CDx in accordance with the Centers for Medicare and Medicaid Services (CMS) national coverage determination (NCD) criteria.
Our client services team is here to help, Monday through Friday 8AM – 8PM EST.
FoundationOne®CDx is a qualitative next-generation sequencing based体外晚期癌症患者的实体肿瘤诊断试验，仅供在处方使用。该试验分析324个基因以及基因组特征，包括微卫星不稳定性（MSI）和肿瘤突变负担（TMB），并且是鉴定可能根据经批准的治疗产品标记的特定疗法受益的患者的伴侣诊断。可以报告额外的基因组发现，并且不规定的或决定性用于标记使用任何特定的治疗产品。使用测试不保证患者将与治疗匹配。否定结果不会排除发生变化的存在。有些患者可能需要活组织检查。对于完整的标签，包括伴侣诊断指示和重要风险信息，请访问www.f1cdxlabel.com.。