Pillar Biosciences OncoReveal CDx Pan-cancer Solid Tumor IVD Now FDA Approved for General Tumor Profiling on the Illumina MiSeq Dx System
Pillar Biosciences OncoReveal CDx Pan-cancer Solid Tumor IVD Now FDA Approved for General Tumor Profiling on the Illumina MiSeq Dx System
Company continues to execute on its global strategy to bring highly accurate and sensitive NGS cancer diagnostics to enable localized testing
公司继续执行其全球战略，提供高度准确和灵敏的NGS癌症诊断以实现本地化测试
NATICK, Mass., April 23, 2024 /PRNewswire/ -- Pillar Biosciences, Inc., the leader in Decision Medicine, which develops and distributes next-generation sequencing (NGS) tests to localize testing and reduce time to treatment initiation and testing costs, today announced that the U.S. Food and Drug Administration (FDA) has approved the company's Premarket Approval (PMA) supplement application for its oncoReveal CDx pan-cancer solid tumor in vitro diagnostic (IVD). The approval expands the indication of oncoReveal Dx from EGFR & KRAS therapy selection in non-small cell lung cancer (NSCLC) and colorectal cancer (CRC) to now include general solid tumor profiling.
马萨诸塞州纳蒂克，2024年4月23日 /PRNewswire/ — 决策医学领域的领导者Pillar Biosciences, Inc. 今天宣布，美国食品药品监督管理局（FDA）已批准该公司OncoReveal CDx泛癌实体瘤的上市前批准（PMA）补充申请，该公司开发和分销下一代测序（NGS）测试，以实现测试本地化并缩短治疗启动时间和测试成本体外诊断（IVD）。该批准将OncoReveal Dx的适用范围从非小细胞肺癌（NSCLC）和结直肠癌（CRC）的表皮生长因子和KRAS疗法选择扩展到现在包括一般实体瘤特征分析。
"We are pleased to have expanded the clinical utility of oncoReveal Dx, which was the first FDA PMA-approved multi-cancer IVD kit launched in the market," said Gang Song, Founder and Executive Chairman of Pillar Biosciences. "In partnership with Illumina, our newest IVD offering, oncoReveal CDx is a pan-cancer solid tumor IVD that will enable critical diagnostic testing to be performed locally in any NGS lab, whether hospital-based or a commercial reference laboratory, running an Illumina MiSeq Dx System. This approach demonstrates our commitment to bringing highly accurate, actionable, and reimbursable NGS testing to clinical laboratories and biopharmaceutical companies to help improve treatment decisions and deliver outcomes that are accessible to everyone, everywhere."
Pillar Biosciences创始人兼执行董事长宋刚表示：“我们很高兴扩大了OncoReveal Dx的临床用途，这是美国食品药品管理局批准的首个在市场上推出的多癌症体外诊断试剂盒。“OncoReveal CDx与我们最新的体外诊断产品Illumina合作，是一款泛癌实体瘤体外检测，它将使关键诊断测试能够在任何运行Illumina MiseQ Dx系统的NGS实验室，无论是医院实验室还是商业参考实验室，都可以在本地进行。这种方法表明我们致力于为临床实验室和生物制药公司提供高度准确、可操作和可报销的NGS测试，以帮助改善治疗决策并提供任何地方所有人都能获得的结果。”
"Illumina is proud to partner with Pillar Biosciences to expand diagnostic offerings on the MiSeq Dx," said Kevin Keegan, General Manager of Oncology at Illumina. "Broadening the market for tumor profiling and therapy selection options is a key enabler of precision medicine and harnesses the power of the genome to improve human health."
Illumina肿瘤学总经理凯文·基根表示：“Illumina很荣幸能与Pillar Biosciences合作，扩大MiseQ Dx的诊断产品范围。”“扩大肿瘤分析和治疗选择的市场是精准医疗的关键推动力，它利用基因组的力量来改善人类健康。”
The oncoReveal CDx pan-cancer solid tumor IVD, which has been validated and approved for use on the Illumina MiSeq Dx System, was developed for tumor profiling and therapy selection and includes actionable targets on most common solid cancer types. The panel covers 22 clinically relevant genes in one multiplex reaction and has a single-day workflow that can be performed by any clinical laboratory with a sample-to-report time of as little as 48 hours. Up to 46 clinical samples can be batched on a single MiSeq Dx run.
OncoReveal CDx泛癌实体瘤体外诊断已通过验证并批准在Illumina MiseQ Dx系统上使用，专为肿瘤分析和治疗选择而开发，包括针对大多数常见实体癌类型的可操作靶标。该小组在一次多重反应中涵盖了22个与临床相关的基因，并具有单日工作流程，任何临床实验室都可以执行，样本到报告的时间短至48小时。单次 MiseQ Dx 运行最多可批处理 46 份临床样本。
This PMA supplement approval follows the original PMA approval of oncoReveal Dx in July 2021. This IVD is also currently CE IVD approved on MiSeq Dx for EGFR & KRAS for therapy selection in non-small cell lung cancer (NSCLC) and colorectal cancer (CRC), and NMPA approved in China for KRAS, BRAF and PIK3CA for therapy selection in CRC.
该PMA补充批准是在2021年7月首次批准OncoReveal Dx的PMA之后批准的。该体外诊断目前还获得了 MiseQ Dx 的 CE IVD 批准，用于 EGFR 和 KRAS，用于非小细胞肺癌 (NSCLC) 和结直肠癌 (CRC) 的疗法选择，中国国家药监局批准用于结直肠癌疗法选择的 KRAS、BRAF 和 PIK3CA。
About Pillar Biosciences
关于 Pillar 生物科学
Pillar Biosciences is the leader in Decision Medicine, which is the utilization of highly accurate and sensitive next-generation sequencing (NGS) testing technology to generate data that optimizes selection of precision therapies for cancer patients, from tumor profiling to therapy selection, and recurrence monitoring. Pillar's NGS testing solutions are powered by its proprietary SLIMamp and PiVAT technologies, helping to localize the testing process, reduce diagnostic costs and improve access and efficiency of complex NGS testing for clinicians, prescribers, and patients globally. The company has more than 20 NGS testing kits available in IVD or RUO formats, with multiple panels in various stages of development. Pillar Biosciences has operations in Natick, MA. For more information visit pillarbiosci.com and connect with us on LinkedIn.
Pillar Biosciences是决策医学领域的领导者，决策医学利用高精度和灵敏度的下一代测序（NGS）测试技术来生成数据，以优化癌症患者精准疗法的选择，包括肿瘤分析、疗法选择和复发监测。Pillar 的 NGS 测试解决方案由其专有的 SlimaMP 和 Pivat 技术提供支持，有助于本地化测试流程，降低诊断成本，并改善全球临床医生、处方者和患者获得复杂 NGS 测试的机会和效率。该公司拥有20多个NGS测试套件以IVD或RUO格式提供，多个试剂盒处于不同的开发阶段。Pillar Biosciences在马萨诸塞州纳蒂克开展业务。欲了解更多信息，请访问 pillarbiosci.com 并通过 LinkedIn 联系我们。
SOURCE Pillar BioSciences Inc
来源 Pillar 生物科学公司