CARLSBAD, Calif.--(BUSINESS WIRE)--Thermo Fisher Scientific, the world leader in serving science, has received approval from the U.S. Food and Drug Administration (FDA) for its Ion Torrent™ Oncomine™ Dx Target Test as a companion diagnostic (CDx) to identify patients eligible for treatment with Servier Pharmaceuticals, LLC’s VORANIGO® (vorasidenib) tablets.

加利福尼亚州卡尔斯巴德（商业新闻短讯）--服务科学领域的全球领导者Thermo Fisher Scientific已获得美国食品和药物管理局（FDA）的批准，将其Ion Torrent™Oncomine™Dx靶标测试作为伴随诊断（CDx），用于识别符合Servier Pharmaceuticals，LLC的VORANIGO®（vorasidenib）片剂治疗条件的患者。

VORANIGO is an isocitrate dehydrogenase-1 (IDH1) and isocitrate dehydrogenase-2 (IDH2) inhibitor indicated for the treatment of adult and pediatric patients 12 years and older with Grade 2 astrocytoma or oligodendroglioma with a susceptible IDH1 or IDH2 mutation following surgery including biopsy, sub-total resection or gross total resection.

VORANIGO 是一种异柠檬酸脱氢酶-1 （IDH1） 和异柠檬酸脱氢酶-2 （IDH2） 抑制剂，适用于治疗 12 岁及以上患有 2 级星形细胞瘤或少突胶质细胞瘤且易感 IDH1 或 IDH2 突变的成人和儿童患者，手术后手术包括活检、次全切除或大体全切除。

As the first targeted therapy for Grade 2 IDH-mutant glioma, VORANIGO provides a new care path for patients with extremely limited treatment options..

作为第一个针对2级IDH突变型胶质瘤的靶向治疗，VORANIGO为治疗选择极其有限的患者提供了一条新的护理途径。。

Gliomas are the most common malignant primary brain tumor in adults, representing approximately 81% of primary malignant brain tumors. Of those, approximately 20% harbor an IDH mutation and testing for these mutations is essential for accurate treatment decisions. Further, the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology recommend IDH mutation testing in all patients with a glioma, noting its impact on diagnosis and prognosis of gliomas.

胶质瘤是成人中最常见的恶性原发性脑肿瘤，约占原发性恶性脑肿瘤的81%。其中，大约20%具有IDH突变，对这些突变的测试对于准确的治疗决策至关重要。此外，国家综合癌症网络（NCCN）肿瘤学临床实践指南建议对所有神经胶质瘤患者进行IDH突变检测，并指出其对神经胶质瘤诊断和预后的影响。

IDH mutation status has been a key factor in the NCCN treatment guidelines for years. With the FDA approval of VORANIGO, determining the IDH mutation status of patients with glioma will be even more critical..

多年来，IDH突变状态一直是NCCN治疗指南中的关键因素。随着FDA对VORANIGO的批准，确定胶质瘤患者的IDH突变状态将更加关键。。

“VORANIGO is the first and only targeted therapy for patients living with grade 2 IDH mutant glioma, a relentless and incurable type of brain cancer that hasn’t seen treatment advances in nearly 25 years,” said David K. Lee, CEO of Servier Pharmaceuticals. “As more targeted therapies become available to patients, identifying key driver mutations is essential to help the right patients find the right treatment, at the right time.”.

施维雅制药首席执行官大卫·K·李（DavidK.Lee）表示：“沃拉尼戈是第一个也是唯一一个针对2级IDH突变型神经胶质瘤患者的靶向治疗方法，这是一种无情且无法治愈的脑癌，近25年来一直没有取得治疗进展。”。“随着患者获得更多针对性的治疗，识别关键的驱动突变对于帮助正确的患者在正确的时间找到正确的治疗至关重要。”。

In addition to the approval for IDH-mutant diffuse glioma, the Oncomine Dx Target Test, has also previously received approvals for indications in non-small cell lung cancer (NSCLC), cholangiocarcinoma (CCA), medullary thyroid cancer (MTC) and thyroid cancer (TC). As a distributable companion diagnostic, the test simultaneously delivers biomarker results for multiple targeted therapies from one sample, helping quickly match patients with the right targeted therapies..

除了IDH突变型弥漫性胶质瘤的批准外，Oncomine Dx靶标测试之前还获得了非小细胞肺癌（NSCLC），胆管癌（CCA），甲状腺髓样癌（MTC）和甲状腺癌（TC）适应症的批准。作为一种可分发的伴随诊断，该测试同时从一个样本中提供多种靶向治疗的生物标志物结果，帮助患者快速匹配正确的靶向治疗。。

“As the healthcare system works to realize the impact of precision medicine, patients must have access to the proper testing that helps unlock targeted treatment options based on their unique genomic profiles. This access is the driving motivation behind the extensive work we do with pharma partners to help connect the right patients to new therapies as soon as they are approved,” said Kathy Davy, president, clinical next-generation sequencing at Thermo Fisher Scientific.

Thermo Fisher Scientific临床下一代测序总裁凯西·戴维（Kathy Davy）表示：“随着医疗保健系统努力实现精准医学的影响，患者必须能够获得适当的测试，以帮助根据其独特的基因组特征解锁靶向治疗方案。这是我们与制药合作伙伴进行广泛工作的驱动力，以帮助正确的患者在获得批准后尽快将其与新疗法联系起来。”。

“The work we do every day reflects our Mission, and combining our CDx technology with Servier’s breakthrough therapy will help dramatically impact care for patients with aggressive brain tumors.”.

“我们每天所做的工作反映了我们的使命，将我们的CDx技术与施维雅的突破性治疗相结合，将有助于极大地影响对侵袭性脑肿瘤患者的护理。”。

Today’s approval expands clinical indications for the Oncomine Dx Target Test, which is currently approved and reimbursed by government and commercial insurers in 19 countries, including the U.S., Japan, South Korea and countries across Europe and the Middle East, covering more than 550 million lives globally..

今天的批准扩大了Oncomine Dx Target测试的临床适应症，该测试目前已获得19个国家的政府和商业保险公司的批准和报销，包括美国、日本、韩国以及欧洲和中东国家，覆盖全球超过5.5亿人的生命。。

Following this approval, the two organizations will continue to collaborate on an additional companion diagnostics with the Ion Torrent™ Oncomine Dx Express Test.* Available on the Ion Torrent Genexus™ Dx System*, the Oncomine Dx Express Test can return results in as little as a single day, dramatically accelerating the pace with which patients can be matched with optimal treatments based on their genomic results..

获得批准后，这两个组织将继续与Ion Torrent™Oncomine Dx Express测试合作进行额外的伴随诊断。*Ion Torrent Genexus™Dx系统*上提供了Oncomine Dx Express测试，Oncomine Dx Express测试可以在短短的一天内返回结果，大大加快了患者根据基因组结果与最佳治疗相匹配的速度。。

About Thermo Fisher Scientific

关于Thermo Fisher Scientific

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue over $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them.

Thermo Fisher Scientific Inc.是服务科学领域的全球领导者，年收入超过400亿美元。我们的使命是让我们的客户使世界更健康、更清洁、更安全。无论我们的客户是在加速生命科学研究，解决复杂的分析挑战，提高实验室的生产力，通过诊断改善患者健康，还是在开发和制造改变生命的疗法，我们都会为他们提供支持。

Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. For more information, please visit www.thermofisher.com..

我们的全球团队通过我们的行业领先品牌，包括Thermo Scientific、Applied Biosystems、Invitrogen、Fisher Scientific、Unity Lab services、Patheon和PPD，提供无与伦比的创新技术、购买便利和制药服务组合。