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
公司繼續執行其全球戰略，提供高度準確和靈敏的NGS癌症診斷以實現本地化測試
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.
馬薩諸塞州納蒂克，2024年4月23日 /PRNewswire/ — 決策醫學領域的領導者Pillar Biosciences, Inc. 今天宣佈，美國食品藥品監督管理局（FDA）已批准該公司OncoReveal CDx泛癌實體瘤的上市前批准（PMA）補充申請，該公司開發和分銷下一代測序（NGS）測試，以實現測試本地化並縮短治療啓動時間和測試成本體外診斷（IVD）。該批准將OncoReveal Dx的適用範圍從非小細胞肺癌（NSCLC）和結直腸癌（CRC）的表皮生長因子和KRAS療法選擇擴展到現在包括一般實體瘤特徵分析。
"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創始人兼執行董事長宋剛表示：“我們很高興擴大了OncoReveal Dx的臨床用途，這是美國食品藥品管理局批准的首個在市場上推出的多癌症體外診斷試劑盒。“OncoReveal CDx與我們最新的體外診斷產品Illumina合作，是一款泛癌實體瘤體外檢測，它將使關鍵診斷測試能夠在任何運行Illumina MiseQ Dx系統的NGS實驗室，無論是醫院實驗室還是商業參考實驗室，都可以在本地進行。這種方法表明我們致力於爲臨床實驗室和生物製藥公司提供高度準確、可操作和可報銷的NGS測試，以幫助改善治療決策並提供任何地方所有人都能獲得的結果。”
"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腫瘤學總經理凱文·基根表示：“Illumina很榮幸能與Pillar Biosciences合作，擴大MiseQ Dx的診斷產品範圍。”“擴大腫瘤分析和治療選擇的市場是精準醫療的關鍵推動力，它利用基因組的力量來改善人類健康。”
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泛癌實體瘤體外診斷已通過驗證並批准在Illumina MiseQ Dx系統上使用，專爲腫瘤分析和治療選擇而開發，包括針對大多數常見實體癌類型的可操作靶標。該小組在一次多重反應中涵蓋了22個與臨床相關的基因，並具有單日工作流程，任何臨床實驗室都可以執行，樣本到報告的時間短至48小時。單次 MiseQ Dx 運行最多可批處理 46 份臨床樣本。
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.
該PMA補充批准是在2021年7月首次批准OncoReveal Dx的PMA之後批准的。該體外診斷目前還獲得了 MiseQ Dx 的 CE IVD 批准，用於 EGFR 和 KRAS，用於非小細胞肺癌 (NSCLC) 和結直腸癌 (CRC) 的療法選擇，中國國家藥監局批准用於結直腸癌療法選擇的 KRAS、BRAF 和 PIK3CA。
About Pillar Biosciences
關於 Pillar 生物科學
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是決策醫學領域的領導者，決策醫學利用高精度和靈敏度的下一代測序（NGS）測試技術來生成數據，以優化癌症患者精準療法的選擇，包括腫瘤分析、療法選擇和復發監測。Pillar 的 NGS 測試解決方案由其專有的 SlimaMP 和 Pivat 技術提供支持，有助於本地化測試流程，降低診斷成本，並改善全球臨床醫生、處方者和患者獲得複雜 NGS 測試的機會和效率。該公司擁有20多個NGS測試套件以IVD或RUO格式提供，多個試劑盒處於不同的開發階段。Pillar Biosciences在馬薩諸塞州納蒂克開展業務。欲了解更多信息，請訪問 pillarbiosci.com 並通過 LinkedIn 聯繫我們。
SOURCE Pillar BioSciences Inc
來源 Pillar 生物科學公司
譯文內容由第三人軟體翻譯。