Hologic, Inc. (Nasdaq: HOLX) announced today that its new Genius™ Digital Diagnostics System with the Genius™ Cervical AI algorithm has received clearance from the U.S. Food and Drug Administration (FDA), making it the first and only FDA-cleared digital cytology system that combines deep-learning-based artificial intelligence (AI) with advanced volumetric imaging technology to help identify pre-cancerous lesions and cervical cancer cells.

Hologic，Inc.（纳斯达克：HOLX）今天宣布其新天才™ Genius数字诊断系统™ 宫颈AI算法已获得美国食品和药物管理局（FDA）的批准，成为FDA批准的第一个也是唯一一个数字细胞学系统，该系统将基于深度学习的人工智能（AI）与先进的体积成像技术相结合，以帮助识别癌前病变和宫颈癌细胞。

“Hologic is a leading innovator in women’s health with a commitment to advancing cervical and breast cancer screening technologies, from the first liquid-based cytology test to the first 3D mammography system and now the first FDA-cleared digital cytology platform,” said Jennifer Schneiders, Ph.D., President, Diagnostic Solutions at Hologic.

Hologic诊断解决方案总裁Jennifer Schneiders博士说：“Hologic是女性健康领域的领先创新者，致力于推进宫颈癌和乳腺癌筛查技术，从第一个基于液体的细胞学检测到第一个3D乳房X线照相系统，现在是第一个FDA批准的数字细胞学平台。”

“Our technologies have had a tremendous impact on decreasing cancer rates in women, and we are incredibly excited by the promise of Genius Digital Diagnostics. The system delivers more actionable and accurate insights for laboratories and healthcare professionals to enhance patient care.”

“我们的技术对降低女性癌症发病率产生了巨大影响，我们对Genius数字诊断的前景感到无比兴奋。该系统为实验室和医疗保健专业人员提供了更可行和准确的见解，以加强患者护理。”

In its most recent update, the American Cancer Society estimated that 13,820 cases of invasive cervical cancer will be diagnosed in the United States in 2024, and approximately 4,360 women will die from the disease. Detecting and identifying cervical cancer in the earliest stages is critical to effective prevention and treatment.

美国癌症协会在其最新更新中估计，2024年美国将诊断出13820例浸润性宫颈癌，约4360名女性将死于该病。早期发现和识别宫颈癌对于有效预防和治疗至关重要。

Screenings for cervical cancer include a Pap test, where a sample is generally collected at an OB-GYN office, and the cervical cells are sent to a lab where they are transferred to a glass slide. To date, this glass slide has been reviewed under a microscope. With the Genius Digital Diagnostics System, the glass slides are digitally imaged and an artificial intelligence algorithm is applied to pinpoint the cells that cytologists and pathologists should review.

宫颈癌筛查包括巴氏涂片检查，通常在妇产科办公室收集样本，并将宫颈细胞送往实验室，在那里将其转移到载玻片上。迄今为止，已经在显微镜下检查了该载玻片。借助Genius数字诊断系统，对载玻片进行数字成像，并应用人工智能算法精确定位细胞学家和病理学家应该审查的细胞。

The new process and technology demonstrated an overall improvement in sensitivity without a corresponding decrease in specificity. Notably, there was a 28% reduction in false negatives of high-grade squamous intraepithelial and more severe lesions compared to microscopic review.1 The Genius Digital Diagnostics System will help laboratories arm healthcare professionals with the information they need to guide more timely and effective treatment decisions for patients.

新的工艺和技术显示出灵敏度的整体提高，而特异性没有相应的降低。值得注意的是，与显微镜检查相比，高度鳞状上皮内病变和更严重病变的假阴性率降低了28%。1 Genius数字诊断系统将帮助实验室为医疗保健专业人员提供所需的信息，以指导患者更及时有效的治疗决策。

The Genius Digital Diagnostics System also offers the opportunity for greater collaboration across lab and other healthcare settings. The system allows cytologists and pathologists to securely review cases remotely, so patients can benefit from the collective knowledge of geographically dispersed experts.

Genius数字诊断系统还提供了跨实验室和其他医疗保健环境进行更大协作的机会。该系统允许细胞学家和病理学家远程安全地审查病例，因此患者可以从地理位置分散的专家的集体知识中受益。

The Genius Digital Diagnostics System consists of the Genius™ Digital Imager for image acquisition, the Genius™ Cervical AI algorithm for image analysis, the Genius™ Image Management Server for image storage and the Genius™ Review Station for local or remote case review. The complete system is scalable and designed to fit the present and future needs of laboratories.

Genius数字诊断系统由Genius组成™ 用于图像采集的数字成像仪，Genius™ 用于图像分析的宫颈AI算法，Genius™ 用于图像存储的图像管理服务器和Genius™ 审查站进行本地或远程病例审查。整个系统具有可扩展性，旨在满足实验室当前和未来的需求。

The Genius Digital Diagnostics System is already commercially available in Europe, Australia and New Zealand. Commercial availability in the U.S. is expected in early 2024.

Genius数字诊断系统已在欧洲、澳大利亚和新西兰上市。预计2024年初在美国上市。

About Cervical Cancer Screening

关于宫颈癌筛查

Cervical cancer is preventable and, if caught early, can be highly treatable. Co-testing — combining a Pap test with an HPV test — has been shown to be the most sensitive testing option for cervical cancer screening compared to either test used alone.2,3,4,5 Hologic pioneered the first FDA-approved liquid-based cytology test, the ThinPrep® Pap test, and the first FDA-approved mRNA-based HPV test, the Aptima® HPV Assay.

宫颈癌是可以预防的，如果早期发现，可以高度治疗。与单独使用的任何一种检测相比，联合检测-将巴氏涂片检测与HPV检测相结合-已被证明是宫颈癌筛查中最敏感的检测选择。2,3,4,5 Hologic开创了第一个FDA批准的基于液体的细胞学检测，ThinPrep®巴氏涂片检测，以及第一个FDA批准的基于mRNA的HPV检测，Aptima®HPV检测。

Healthcare professionals have the choice to perform a co-test with ThinPrep and Aptima.

医疗保健专业人员可以选择与ThinPrep和Aptima进行联合测试。

About Hologic, Inc.

关于Hologic，Inc。

Hologic, Inc. is a global medical technology innovator focused on improving the health and well-being of women, their families and communities through early detection and treatment. Its advancements include invention of the world’s first commercial 3D mammography system to find breast cancer earlier; leadership in testing for cervical cancer, sexually transmitted infections and respiratory illnesses; minimally invasive surgical technologies for uterine fibroids and abnormal uterine bleeding; and advanced vessel sealing and dissection devices.

Hologic，Inc.是一家全球医疗技术创新公司，致力于通过早期发现和治疗改善女性及其家庭和社区的健康和福祉。它的进步包括发明了世界上第一个商业3D乳腺X线摄影系统，可以更早地发现乳腺癌；领导宫颈癌、性传播感染和呼吸道疾病检测；子宫肌瘤和异常子宫出血的微创手术技术；以及先进的血管密封和解剖设备。

The company also champions women through the Hologic Global Women’s Health Index, which provides a science-backed data framework for improving women’s well-being.

该公司还通过Hologic全球女性健康指数（Hologic Global women's Health Index）为女性提供支持，该指数为改善女性福祉提供了科学支持的数据框架。