继上月16日FDA批准MSK的多基因检测panel：MSK-IMPACT™。2017年12月1日，FDA和CMS同时批准Foundation Medicine旗下产品--FoundationOne CDx（F1CDx）用于泛癌症临床伴随诊断，这是首款突破性的基于NGS的体外诊断产品，能对任何实体肿瘤进行诊断，在体外诊断领域具有里程碑式的意义。

F1CDx覆盖324个基因的遗传突变以及两类基因组特征，能够高效检测肿瘤基因的SNV、Inedel、MSI以及TMB等。通过与FDA之前批准的伴随诊断对比，F1CDx的总体准确率可达到94.6％。

以往的伴随诊断往往是特定诊断对应特定药物，即“一对一”的模式。而今日批准的F1CDx超出了之前“一对一”的模式，它能够帮助医生对任何实体肿瘤患者进行诊断，从而帮助患者更好地管理自己的病程。此外，在非小细胞肺癌、黑色素瘤、乳腺癌、结直肠癌、以及卵巢癌患者中，它还能找对可以从FDA已批准的15种靶向药物受益的患者。

“先前的诊断往往需要多次取样，才能做出药物治疗或参加临床试验的决定；而F1CDx无需频繁的侵入性检测，就能帮助医生获得更多信息进行治疗选择” 。 FDA医疗设备和放射健康中心的Jeffrey博士说：“通过F1CDx一次检测，患者和医生就能评估多种病程管理方案”。

精准医学的迅猛发展已经为肿瘤患者带来许多福音。同时，我们也期待国内精准医疗企业能够开发出针对中国肿瘤患者优秀产品，为他们提供最准确的临床治疗指导信息，实现最大化临床获益。

—— 新闻稿原文 ——

FDA Approves Foundation Medicine's FoundationOne CDx™, the First and Only Comprehensive Genomic Profiling Test for All Solid Tumors Incorporating Multiple Companion Diagnostics

--Landmark approval advances personalized cancer care as an estimated 1 in 3 patients across five common advanced cancers are expected to match with an FDA-approved therapy--

--The Centers for Medicare and Medicaid Services issued a preliminary National Coverage Determination (NCD) for FoundationOne CDx, improving access to molecular information for personalized healthcare--

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Foundation Medicine, Inc. (NASDAQ:FMI) today announced that the U.S. Food and Drug Administration (FDA) approved FoundationOne CDx™, the company's comprehensive companion diagnostic test for solid tumors. FoundationOne CDx is intended for use by health care professionals to help inform cancer treatment management in accordance with professional guidelines for patients with solid tumors. The first and only FDA-approved test of its kind for all solid tumors, FoundationOne CDx is a diagnostic test that acts as:

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• a comprehensive companion diagnostic to identify patients who may benefit from treatment with specific FDA-approved targeted therapies;

• a comprehensive genomic profiling (CGP) test that includes genomic biomarkers to help inform the use of other targeted oncology therapies, including immunotherapies;

• a tool for physicians that identifies patient opportunities for clinical trial participation; and,

• an FDA-approved platform for companion diagnostic development for biopharma companies developing precision therapeutics.

FoundationOne CDx assesses all classes of genomic alterations in 324 genes known to drive cancer growth, providing potentially actionable information to help guide treatment decisions. It is also indicated as a companion diagnostic for patients with certain types of non-small cell lung cancer (NSCLC), melanoma, colorectal cancer, ovarian cancer or breast cancer to identify those patients who may benefit from treatment with one of 17 on-label targeted therapies, including 12 therapies currently approved as first-line therapy for their respective indications. FoundationOne CDx also reports genomic biomarkers, such as microsatellite instability (MSI) and tumor mutational burden (TMB), that can help inform the use of immunotherapies; genomic alterations in other genes relevant to patient management; and, relevant clinical trial information.

Based on previous CGP testing conducted by Foundation Medicine, it is estimated that approximately 1 in 3 patients across five common advanced cancers are expected to match with an FDA approved therapy.1 The number of matched on-label therapies indicated on FoundationOne CDx is expected to increase over time as Foundation Medicine and its biopharma partners pursue FDA approval for additional companion diagnostics on the platform. Today, approximately 50% of new cancer drugs in development are projected to have a companion biomarker.2

Concurrent with FDA approval, the Centers for Medicare and Medicaid Services (CMS) issued a preliminary National Coverage Determination (NCD) for FoundationOne CDx. The draft NCD would provide coverage for FDA-approved companion diagnostic claims, as well as a pathway for additional coverage with evidence development in other solid tumor types. The final policy is expected to issue during the first quarter of 2018 following public comment of the preliminary NCD and an administrative period.

"Today we know that many people with cancer do not receive biomarker testing, let alone the comprehensive genomic testing they need to be efficiently matched to the best therapeutic option," said Andrea Ferris, President and CEO of LUNGevity Foundation. "This FDA approval means that, in one test, patients can access therapies where companion diagnostics have been established for their cancer while getting a broad tumor profile that can identify the therapies and clinical trials they could most benefit from. Along with the preliminary national coverage determination, this has the potential to democratize next-generation sequencing, lowering the barriers for patients treated in the community to access these biomarker-driven treatments."

"Comprehensive genomic profiling is the gateway to precision medicine. This decision from the FDA and CMS, which may lead to coverage for Medicare patients, represents an important step forward in improving patient and clinician access to precision medicine - both in setting a new quality standard for this type of testing and offering potentially improved healthcare coverage," said Ankur R. Parikh, DO, Medical Director of Precision Medicine, Cancer Treatment Centers of America. "Access to important genomic information is a critical step in being able to offer innovative and targeted treatment options."

FoundationOne CDx results are delivered in an integrated report that identifies alterations matched to FDA approved therapies, identifies additional alterations in genes known to drive cancer growth, furnishes information about genomic biomarkers, including MSI and TMB, provides relevant clinical trial information, and includes interpretive content developed in accordance with professional guidelines in oncology for patients with any solid tumor.

"Today's historic parallel review decision from the FDA and CMS represents a major advancement in personalized cancer care," said Troy Cox, chief executive officer at Foundation Medicine. "Physicians will have an FDA-approved test for all solid tumors in their toolkit that can inform targeted and immunotherapy selection, as well as identify patient opportunities for clinical trial participation. Beyond its implications for patient care, we expect that FoundationOne CDx will provide biopharma companies with an FDA-approved platform that can help accelerate drug development and enable personalized oncology care. On behalf of the Foundation Medicine team, I'd like to thank FDA and CMS for their leadership and collaboration as we continue to work through the parallel review process with a shared mission of transforming cancer care."

FoundationOne CDx is the first solid tumor comprehensive genomic profiling test reviewed by the FDA and CMS in their Parallel Review program. FDA approval was based on analytic validation and concordance studies with FDA-approved assays. FoundationOne CDx is expected to be commercially available following finalization of the NCD from CMS.

Conference Call and Webcast Details
Foundation Medicine will conduct a conference call to discuss FDA approval and the draft national coverage determination from CMS for FoundationOne CDx on Friday, December 1 at 8:30 a.m. ET. To access the conference call via phone, dial 1-877-270-2148 from the United States and Canada, or dial 1-412-902-6510 internationally, and for either number reference Foundation Medicine. Dial in approximately ten minutes prior to the start of the call. The live, listen-only webcast of the conference call may be accessed by visiting the investors section of the company's website at investors.foundationmedicine.com. A replay of the webcast will be available shortly after the conclusion of the call and will be archived on the company's website for two weeks following the call.

About FoundationOne CDx™
FoundationOne CDx™ is a next generation sequencing based in vitro diagnostic device for detection of substitutions, insertion and deletion alterations (indels), and copy number alterations (CNAs) in 324 genes and select gene rearrangements, as well as genomic signatures including microsatellite instability (MSI) and tumor mutational burden (TMB) using DNA isolated from formalin-fixed paraffin embedded (FFPE) tumor tissue specimens. The test is intended as a companion diagnostic to identify patients who may benefit from treatment with the targeted therapies listed below in accordance with the approved therapeutic product labeling. Additionally, FoundationOne CDx is intended to provide tumor mutation profiling to be used by qualified health care professionals in accordance with professional guidelines in oncology for patients with solid malignant neoplasms. The FoundationOne CDx assay is a single-site assay performed at Foundation Medicine, Inc.

• EGFR exon 19 deletions and EGFR exon 21 L858R alterations, which may indicate efficacy of erlotinib, afatinib or gefitinib in patients with NSCLC.

• EGFR exon 20 T790M alterations which may indicate efficacy of osimertinib in NSCLC patients

• ALK rearrangements which may indicate efficacy of crizotinib, alectinib or ceritinib in NSCLC patients

• BRAF V600E which may indicate efficacy of dabrafenib in combination with trametinib in NSCLC patients

• BRAF V600E which may indicate efficacy of vemurafenib or dabrafenib in melanoma patients

• BRAF V600E and V600K which may indicate efficacy of trametinib or cobimetinib in combination with vemurafenib in melanoma patients

• ERBB2 (HER2) amplification which may indicate efficacy of trastuzumab, pertuzumab or ado-trastuzumab emtansine in patients with breast cancer

• KRAS wild-type (absence of mutations in codons 12 and 13) which may indicate efficacy of cetuximab in patients with colorectal cancer

• KRAS wild-type (absence of mutations in exons 2, 3 and 4) and NRAS wild-type (absence of mutations in exons 2, 3 and 4) which may indicate efficacy of panitumumab in patients with colorectal cancer

• BRCA1/2 alterations which may indicate efficacy of rucaparib in patients with ovarian cancer

For more information about FoundationOne CDx, visit http://www.FoundationMedicine.com.

About Foundation Medicine
Foundation Medicine (NASDAQ:FMI) is a molecular information company dedicated to a transformation in cancer care in which treatment is informed by a deep understanding of the genomic changes that contribute to each patient's unique cancer. The company offers a full suite of comprehensive genomic profiling assays to identify the molecular alterations in a patient's cancer and match them with relevant targeted therapies, immunotherapies and clinical trials. Foundation Medicine's molecular information platform aims to improve day-to-day care for patients by serving the needs of clinicians, academic researchers and drug developers to help advance the science of molecular medicine in cancer. For more information, please visit http://www.FoundationMedicine.com or follow Foundation Medicine on Twitter (@FoundationATCG).

Foundation Medicine® is a registered trademark of Foundation Medicine, Inc.

（Source：Foundation Medicine Homepage）