QIAGEN Launches QIAcuityDx Digital PCR System For Clinical Testing In Oncology
QIAGEN Launches QIAcuityDx Digital PCR System For Clinical Testing In Oncology
QIAGEN N.V. (NYSE:QGEN, Frankfurt Prime Standard: QIA))))) today announced the launch of the QIAcuityDx Digital PCR System, a pivotal addition to its digital PCR portfolio now expanding into clinical diagnostics. The instrument and accessories are 510(k) exempt in the U.S. and IVDR-certified for diagnostic use in Europe.
QIAGEN N.V.（紐交所：QGEN，法蘭克福交易所：QIA）今天宣佈推出QIAcuityDx數字PCR系統，這是其數字PCR產品組合的重要補充，現在正在擴展到臨床診斷。該儀器及配件在美國獲得了510（k）豁免，在歐洲獲得了用於診斷用途的IVDR認證。
QIAcuityDx streamlines clinical testing by providing highly precise, absolute quantitation of target DNA and RNA, supporting applications with less invasive liquid biopsies. These capabilities make it an ideal tool for monitoring cancer progression, complementing routine cancer diagnoses, which are typically performed using Next Generation Sequencing (NGS).
QIAcuityDx通過提供對靶DNA和RNA進行高度精確的絕對定量來簡化臨床測試，支持應用於更少侵入性液體活檢。這些功能使其成爲監測癌症進展的理想工具，爲常規癌症診斷提供補充，後者通常使用下一代測序（NGS）進行。
QIAGEN is rapidly expanding the application menu available on QIAcuityDx-System, with a new BCR::ABL assay for oncohematology planned for FDA submission in 2025. The platform also provides immediate access to QIAGEN's full portfolio of research-use products and applications via its GeneGlobe platform. QIAGEN has already signed three partnerships with pharmaceutical companies to develop companion diagnostics on the QIAcuityDx, moving digital PCR into precision medicine. In addition, QIAGEN plans to further enhance the future assay portfolio by collaborating with third parties, who will develop their own assays for the platform.
QIAGEN正迅速擴展可在QIAcuityDx系統上使用的應用菜單，計劃在2025年向FDA提交用於腫瘤血液病學的新BCR::ABL檢測。該平台還通過其GeneGlobe平台立即獲得QIAGEN的全套研究用產品和應用。QIAGEN已與三家制藥公司簽訂合作協議，共同開發用於QIAcuityDx的伴侶診斷，將數字PCR推向精準醫學。此外，QIAGEN計劃通過與第三方合作，這些第三方將開發適用於該平台的自己的檢測，進一步增強未來的檢測組合。