Hologic推出具有扩展CE标志的数字病理学功能-动脉网

Hologic Introduces Digital Pathology Capabilities With Expanded CE Marking

AHHM 等信源发布 2025-11-13 14:41

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Hologic, Inc. announced today that its Genius™ Digital Diagnostics System achieved expanded CE marking in the European Union and is now approved to image and review both cell and tissue specimens. Previously, the system was CE marked specifically for cell analysis, notably used in cervical cancer screening, among other applications.

豪洛捷公司今天宣布，其 Genius™ 数字诊断系统在欧盟获得了扩展的CE认证，现已被批准用于成像和分析细胞及组织样本。此前，该系统专门针对细胞分析获得CE认证，主要应用于宫颈癌筛查等领域。

With the ability to image the entire slide for review of a broader range of patient sample types, the Genius Digital Diagnostics System will allow European labs to unify digital workflows with one comprehensive solution and support pathologists in their work diagnosing a variety of cancers and other diseases..

通过能够对整个玻片进行成像以审查更广泛的患者样本类型，Genius 数字诊断系统将允许欧洲实验室用一个全面的解决方案统一数字工作流程，并在病理学家诊断各种癌症和其他疾病的工作中提供支持。

The ability to image the entire slide is known as “whole slide imaging.” This means that, for example, the same system can assist in identifying pre-cancerous lesions and cervical cancer cells during cervical cancer screenings, while also enabling pathologists to review cervical tissue biopsies to help confirm diagnosis if an abnormality is detected.

整个切片成像的能力被称为“全切片成像”。这意味着，例如，同一系统可以在宫颈癌筛查中协助识别癌前病变和宫颈癌细胞，同时使病理学家能够审查宫颈组织活检，以帮助在检测到异常时确认诊断。

Similarly, for breast health, whole slide imaging allows labs to digitize and review tissue from a breast biopsy – a crucial step when an abnormality is detected during a mammogram to help diagnose or exclude breast cancer. Importantly, this capability is not limited to cervical and breast tissue; it can be leveraged for a wide variety of patient sample types and diagnostic needs, supporting more comprehensive and flexible pathology workflows..

同样，对于乳腺健康，全切片成像技术使实验室能够数字化并审查来自乳腺活检的组织——这是在乳房X光检查发现异常时帮助诊断或排除乳腺癌的关键步骤。重要的是，这种能力不仅限于宫颈和乳腺组织；它可以应用于多种患者样本类型和诊断需求，支持更全面和灵活的病理工作流程。

Today, most labs rely on multiple systems for review of different patient sample types. This separation can create inefficiencies for the lab, which can increase operational costs, extend turnaround times and create additional work for lab staff. Using advanced volumetric imaging technology, Hologic’s Genius Digital Diagnostics System offers the ability to efficiently capture high quality digital images of cell and tissue specimens to then be stored, distributed and reviewed all on a single platform..

如今，大多数实验室依赖多个系统来审查不同类型的患者样本。这种分离可能会导致实验室效率低下，增加运营成本、延长周转时间，并给实验室工作人员带来额外的工作量。豪洛捷公司的Genius数字诊断系统采用先进的体积成像技术，能够高效捕获细胞和组织样本的高质量数字图像，并在一个单一平台上完成存储、分发和审查。

'Placing digital pathology at the center of diagnostic workflows has the potential to transform the way we approach cancer diagnosis and prevention,” said Paul van Diest, Professor, Department of Pathology, University Medical Center Utrecht. “The ability to image and review more specimen types on a single system will help pathologists think beyond traditional boundaries and bring greater accuracy and efficiency to our work.”.

“将数字病理学置于诊断工作流程的中心有可能改变我们进行癌症诊断和预防的方式，”乌得勒支大学医学中心病理学系教授保罗·范·迪斯特说。“在单一系统上对更多样本类型进行成像和审查的能力将帮助病理学家突破传统界限，为我们的工作带来更高的准确性和效率。”

“Access to innovative technology in the laboratory can be a foundation for better patient care,” said Jennifer Schneiders, Ph.D., President, Diagnostic Solutions at Hologic. “Expanding our CE marking with digital pathology will help bring advanced technology to more laboratories across Europe and signals another incredible step in Hologic’s innovation pipeline focused on providing accurate and efficient results to support disease screening and diagnosis.”.

“实验室中的创新技术可以为更好的患者护理奠定基础，” Hologic诊断解决方案总裁Jennifer Schneiders博士说道。“通过数字病理扩展我们的CE标志，将有助于把先进技术带到欧洲更多的实验室，这也标志着Hologic专注于提供准确且高效结果以支持疾病筛查和诊断的创新管道又迈出了令人难以置信的一步。”

With the Genius Digital Diagnostics System, glass slides containing a patient specimen are quickly converted into high-resolution digital images using volumetric imaging technology. This process simultaneously captures 14 layers of the patient specimen and converts them into a single, two-dimensional view.

通过Genius数字诊断系统，包含患者标本的玻璃片利用体积成像技术迅速转化为高分辨率的数字图像。这一过程同时捕获患者标本的14个层面，并将它们转换为单一的二维视图。

Once complete, the entire case is sent to the system’s image management server for secure storage and hands-free case management. It can then be reviewed locally or remotely, helping experts make an interpretation or diagnosis efficiently. This process is now applicable to cell and tissue specimens.

一旦完成，整个病例将被发送到系统的影像管理服务器进行安全存储和免提病例管理。随后可以本地或远程审查，帮助专家高效地进行解读或诊断。该过程目前适用于细胞和组织样本。

The expansion also comes with additional software capabilities such as remote support, laboratory information system (LIS) readiness, new review tools and more..

扩展功能还带来了更多的软件能力，例如远程支持、实验室信息系统 (LIS) 准备就绪、新的审核工具等。

Hologic’s digital pathology solutions were CE marked in the European Union in accordance with the In Vitro Diagnostic Regulation, which is also recognized by other countries around the world. Commercialization per country will be announced. Whole slide imaging is currently not available in the United States..

霍洛吉克公司的数字病理学解决方案已根据《体外诊断法规》在欧盟获得CE标志，该标志也得到世界各国的认可。各国的商业化进程将另行宣布。全切片成像目前在美国尚不可用。

To learn more about Genius Digital Diagnostics, visit here.

要了解有关Genius Digital Diagnostics的更多信息，请访问这里。

About Hologic

关于豪洛捷

Hologic, Inc. is a global leader in women’s health dedicated to developing innovative medical technologies that effectively detect, diagnose and treat health conditions and raise the standard of care around the world. For more information on Hologic, visit www.hologic.com and connect with us on LinkedIn, Facebook, X, Instagram and YouTube..

Hologic, Inc. 是一家全球领先的女性健康公司，致力于开发创新的医疗技术，有效检测、诊断和治疗健康问题，提高全球护理标准。如需了解更多信息，请访问 www.hologic.com，并在 LinkedIn、Facebook、X、Instagram 和 YouTube 上与我们联系。

Forward-Looking Statements

前瞻性声明

This press release may contain forward-looking information that involves risks and uncertainties, including statements about the use of Hologic’s Genius™ Digital Diagnostics System. There can be no assurance these products will achieve the benefits described herein or that such benefits will be replicated in any particular manner with respect to an individual patient.

本新闻稿可能包含涉及风险和不确定性的前瞻性信息，包括关于使用豪洛捷公司的Genius™数字诊断系统的声明。无法保证这些产品能够实现本文所述的效益，也无法保证在任何特定情况下针对个别患者会复制出相同的效益。

The actual effect of the use of the products can only be determined on a case-by-case basis depending on the particular circumstances and patient in question. In addition, there can be no assurance that these products will be commercially successful or achieve any expected level of sales. Hologic expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any such statements presented herein to reflect any change in expectations or any change in events, conditions or circumstances on which any such statements are based..

产品的实际使用效果只能根据具体情况进行个案评估，具体情况和患者各异。此外，无法保证这些产品会取得商业成功或达到任何预期的销售水平。Hologic明确声明，不承担任何公开发布对本文中陈述的声明进行更新或修订的义务或责任，以反映任何期望的变化或任何相关事件、条件或情况的变化。

Hologic and Genius are trademarks or registered trademarks of Hologic, Inc. in the United States and/or other countries.

Hologic 和 Genius 是 Hologic, Inc. 在美国和/或其他国家的商标或注册商标。

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