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.（纽交所：QGEN，法兰克福交易所：QIA）今天宣布推出QIAcuityDx数字PCR系统，这是其数字PCR产品组合的重要补充，现在正在扩展到临床诊断。该仪器及配件在美国获得了510（k）豁免，在欧洲获得了用于诊断用途的IVDR认证。
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通过提供对靶DNA和RNA进行高度精确的绝对定量来简化临床测试，支持应用于更少侵入性液体活检。这些功能使其成为监测癌症进展的理想工具，为常规癌症诊断提供补充，后者通常使用下一代测序（NGS）进行。
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正迅速扩展可在QIAcuityDx系统上使用的应用菜单，计划在2025年向FDA提交用于肿瘤血液病学的新BCR::ABL检测。该平台还通过其GeneGlobe平台立即获得QIAGEN的全套研究用产品和应用。QIAGEN已与三家制药公司签订合作协议，共同开发用于QIAcuityDx的伴侣诊断，将数字PCR推向精准医学。此外，QIAGEN计划通过与第三方合作，这些第三方将开发适用于该平台的自己的检测，进一步增强未来的检测组合。
