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底座®CDX.

什么是底座cdx?

底座CDX.

底座CDX是第一个FDA批准的基于组织的宽伴伴诊断(CDX),其临床和分析验证所有实体瘤。该测试旨在提供具有临床可行信息的医生 - 既可考虑患者的适当疗法,并根据每个患者癌症的个体基因组概况,理解抗性的证据。金博宝188亚洲体育app

测试结果包括微卫星不稳定性(MSI)和肿瘤突变负担(TMB),以帮助提供卵巢癌患者的免疫疗法决策和杂合子(LOH)的丧失。你也可以订购PD-L1免疫组织化学(IHC)测试*as an optional add-on test. We offer the option to reflex from FoundationOne CDx testing to底座®Liquidcdx.如果提交的组织不符合成功测试的标准。

底座CDX.has national coverage for qualifying Medicare and Medicare Advantage patients across all solid tumors.

订单测试

All Solid Tumors

A single test analyzes guideline-recommended genes in solid tumors, including companion diagnostic indications with a direct path to therapy. FoundationOne CDx also has national coverage for qualifying Medicare and Medicare Advantage patients across all solid tumors.†

20.+ FDA-approved targeted therapies

The comprehensive platform includes genes and biomarkers associated with current FDA-approved therapies and others potentially relevant to future approvals.

Genomic Signatures

结果包括MSI和TMB,可选择添加PD-L1 *测试以帮助提供免疫疗法决策。卵巢癌患者的结果包括杂合性丧失(LOH)。

Indications

伴侣诊断迹象

Indications

生物标志物 FDA批准治疗‡

EGFRexon 19 deletions &EGFRexon 21 L858R alterations

Gilotrif®.(afatinib),Iressa®(gefitinib),Tagrisso®(osimertinib), orTarceva®.(erlotinib)

EGFR外显子20 T790M改变

Tagrisso®(osimertinib)

ALKrearrangements

Alecensa®(alectinib),Xalkori®(crizotinib), orZykadia®.(ceritinib)

BRAF.V600E

Tafinlar®(dabrafenib) in combination withMekinist®(trametinib)

MET单核苷酸变体(SNV)和导致的诱导METexon 14 skipping

塔巴切TM值(Capmatinib)

生物标志物 FDA批准治疗‡

BRAF.V600E

Tafinlar®(dabrafenib) orZelboraf®(vemurafenib)

BRAF.V600E或V600K.

Mekinist®(Trametinib)或Cotellic®.(cobimetinib), in combination withZelboraf®(vemurafenib)

生物标志物 FDA批准治疗‡

ERBB2(HER2)扩增

Herceptin®.(trastuzumab),Kadcyla®(ado-trastuzumab-emtansine), orperjeta®.(pertuzumab)

PIK3CAC420R, E542K, E545A, E545D [1635G>T only], E545G, E545K, Q546E, Q546R, H1047L, H1047R, and H1047Y alterations

Piqray®(alpelisib)

生物标志物 FDA批准治疗‡

克拉斯wild-type (absence of mutations in codons 12 and 13)

erbitux®(西妥昔单抗)

克拉斯wild-type (absence of mutations in exons 2, 3, and 4) andNRASwild type (absence of mutations in exons 2, 3, and 4)

Vectibix®(panitumumab)

生物标志物 FDA批准治疗‡

BRCA1/2改变

LynParza®.(olaparib)或Rubraca®(Rucaparib)

生物标志物 FDA批准治疗‡

FGFR2fusions and select rearrangements

PemazyreTM值(pemigatinib)

生物标志物 FDA批准治疗‡

同源重组修复(HRR)基因(BRCA1BRCA2atmBARD1.Brip1.CDK12.Chek1.Chek2.FANCLPALB2RAD51BRAD51CRAD51DandRAD54L)改变

LynParza®.(olaparib)

生物标志物 FDA-Approved Therapy‡

TM值B≥ 10 mutations per megabase

Keytruda®.(Pembrolizumab)

NTRK1 / 2/3fusions

Vitrakvi®(Larotrectinib)

Real-life Results

Real-life Results

了解有关底座CDX在许多癌症类型中的临床效用。

  • Sample Report

    NSCLC样本报告

    View a FoundationOne CDx non-small cell lung cancer (NSCLC) sample report. This report shows anEGFRmutation and elevated TMB.

    Download Sample Report
  • NSCLC Profiler

    Uncovering Treatment Options for Patients with Non-Small Cell Lung Cancer (NSCLC)

    我们的测试组合分析了NSCLC患者的相关改动基因和生物标志物,包括EGFRALKROS1BRAF.ntrk,遇见了,pd-l1 *和基因组特征如tmb。§

    下载nsclc profiler.
  • 博客帖子

    An End-to-end Approach to Precision Medicine: MET exon 14 Skipping Mutations in Non-small Cell Lung Cancer (NSCLC)

    底座CDX.was approved to identify mutations that lead toMET外显子14在先进的非小细胞肺癌(NSCLC)中跳过,并与新的靶向治疗患者进行批准。

    Read the full blog post
  • 新闻稿

    博188金宝ASCO20的基础医学和Dana-Fasber目前的数据显示,综合基因组分析鉴定了可能导致Metex14改变的NSCLC患者造成治疗的共同发生的改变

    改变导致外显子14的跳跃MET基因(METex14) are drivers of a type of lung cancer with a poor prognosis, but that is treatable with a recently approved MET inhibitor.

    查看全新闻稿
  • 样本报告

    Colorectal Cancer (CRC) Sample Report

    View a FoundationOne CDx CRC sample report. This report shows results with a克拉斯检测到改变。

    Download Sample Report
  • 结肠直肠癌(CRC)分析器

    Uncovering Treatment Options for Patients with Colorectal Cancer

    我们的测试组合分析了所有准则推荐的基因和生物标志物,用于CRC患者的相关改动,包括克拉斯NRASBRAF.HER2,and genomic signatures like TMB and MSI.|

    Download CRC Profiler
  • Publication

    Tumor Mutational Burden Is Predictive of Response to Immune Checkpoint Inhibitors in MSI-high Metastatic Colorectal Cancer

    具有MSI-HIGH(MSI-H)的转移性结肠直肠癌(MCRC)中的PD-1抑制剂证明了高疾病控制率和有利的无进展存活(PFS);然而,对Pembrolizumab和Nivolumab的回应率是可变的并且通常<50%,表明需要额外的预测生物标志物。

    View the Publication
  • 博客帖子

    综合基因组分析在结直肠癌中的作用

    We’ve made incredible progress in CRC research, but there is more to be done to inform and enable access to precision medicine options for more patients. As we learn more about the biology of cancer, we are finding that the age-related differences in cancer drivers can be extremely important when it comes to finding the right treatment option.

    Read the Full Blog Post
  • Sample Report

    前列腺癌Sample Report

    查看底座CDX前列腺样本报告。此报告显示结果BRCA2检测到改变。

    Download Sample Report
  • 前列腺探查器

    解锁转移前列腺癌患者的新治疗选择金博宝188亚洲体育app

    我们的测试组合分析了所有准则推荐的基因和生物标志物,用于前列腺癌患者的相关改动,包括:BRCA1BRCA2atmPALB2FANCARAD51DChek2.CDK12.那and genomic signatures like MSI.|

    Prostate Profiler
  • 新闻稿

    博188金宝基础医学获得美国食品及药物管理局批准但书dationOne®CDx as the Companion Diagnostic for LYNPARZA® to Identify Patients with HRR-Mutated Metastatic Castration-Resistant Prostate Cancer

    FACEDENE®CDX是FDA批准为Lynparza®的伴随诊断,用于识别HRR突变转移性阉割前列腺癌的患者

    Prostate Press Release
  • 出版物

    Olaparib for Metastatic Castration-Resistant Prostate Cancer

    LYNPARZA® was approved based on positive results from the PROfound study for which Foundation Medicine served as the Next-Generation Sequencing (NGS) partner.

    View Publication
  • 样本报告

    乳腺癌样本报告

    View a FoundationOne CDx breast cancer sample report. This report shows results with aPIK3CA检测到改变。

    Download Sample Report
  • BREAST CANCER PROFILER

    解锁转移乳腺癌患者的新治疗选择金博宝188亚洲体育app

    我们的测试组合分析了乳腺癌患者的相关改动的指导推荐基因,包括ERBB2(HER2),BRCA1BRCA2andPIK3CAand offer a supplemental IHC-test for PD-L1.*

    DOWNLOAD BREAST CANCER PROFILER
  • BLOG POST

    Breast cancer – a very personal history and an even more personalized future

    Learn more about how comprehensive genomic profiling can impact treatment options for breast cancer patients, as our CEO Cindy Perettie reflects on data presented at the latest SABCS conference.

    阅读完整博客帖子
  • 出版物

    综合基因组测序和临床晚期乳腺癌的分子谱

    Ngs的综合基因组分析(CGP)可以揭示可靶向临床相关的基因组改变,其可以通过预测对各种疗法的敏感性来分析肿瘤,包括HER2或MTOR靶向疗法,免疫疗法和其他激酶抑制剂。

    VIEW PUBLICATION

FAQ and Resources

底座CDX.Resources

We’re Here to Help

Questions? Our Client Services team is on hand to help.

联系我们

Additional Notes

*PD-L1 by Immunohistochemistry (IHC)可以作为补充测试订购,并可以不同癌症类型的若干免疫治疗提供信息

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.

 特罗凯® 是OSI制药的注册商标aceuticals, LLC. Zelboraf®, Herceptin®, Perjeta®, Kadcyla®, and Cotellic® are registered trademarks of Genentech, Inc. Gilotrif® is a registered trademark of Boehringer Ingelheim International GmbH. Iressa® and Tagrisso® are registered trademarks of the AstraZeneca AB Corporation. Xalkori® is a registered trademark of Pfizer Inc. Zykadia®, Tafinlar®, and Mekinist® are registered trademarks of Novartis AG Corporation Switzerland. Erbitux® is a registered trademark of ImClone LLC, a wholly owned subsidiary of Eli Lilly and Company. Alecensa® is a registered trademark of Chugai Seiyaku Kabushiki Kaisha. Vectibix® is a registered trademark of Immunex Corporation. Rubraca® is a registered trademark of Clovis Oncology, Inc. Piqray® is a registered trademark of Novartis AG. TabrectaTM值is a trademark of Novartis AG. PemazyreTM值是Incyte Holdings Corporation的商标。Keytruda®是Merck Sharp&Dohme公司的注册商标。

§B基础液体CDX报告BTMB作为实验室专业服务。

|将报告MSI状态,用于确定具有高微卫星不稳定作为实验室专业服务的样本。

博188金宝基础医学detects both somatic and germline alterations but does not differentiate between the two on reports.

Important Safety Information

选择

底座CDX.

底座®CDX.is a qualitative next-generation sequencing basedin vitrodiagnostic test for advanced cancer patients with solid tumors and is for prescription use only. The test analyzes 324 genes as well as genomic signatures including microsatellite instability (MSI) and tumor mutational burden (TMB) and is a companion diagnostic to identify patients who may benefit from treatment with specific therapies in accordance with the approved therapeutic product labeling. Additional genomic findings may be reported and are not prescriptive or conclusive for labeled use of any specific therapeutic product. Use of the test does not guarantee a patient will be matched to a treatment. A negative result does not rule out the presence of an alteration. Some patients may require a biopsy. For the complete label, including companion diagnostic indications and important risk information, please visitwww.F1CDxLabel.com。 

底底液体CDX.

底座®Liquidcdx.is for prescription use only and is a qualitative next-generation sequencing basedin vitrodiagnostic test for advanced cancer patients with solid tumors. The test analyzes 324 genes utilizing circulating cell-free DNA and is FDA-approved to report short variants in 311 genes and as a companion diagnostic to identify patients who may benefit from treatment with specific therapies (listed in Table 1 of the Intended Use) in accordance with the approved therapeutic product labeling. Additional genomic findings may be reported and are not prescriptive or conclusive for labeled use of any specific therapeutic product. Use of the test does not guarantee a patient will be matched to a treatment. A negative result does not rule out the presence of an alteration. Patients who are negative for companion diagnostic mutations should be reflexed to tumor tissue testing and mutation status confirmed using an FDA-approved tumor tissue test, if feasible. For the complete label, including companion diagnostic indications and complete risk information, please visitwww.F1LCDxLabel.com