NEW YORK – With the US launch of its clinical-use digital pathology system, Epredia aims to win over labs with its high-throughput scanner, automated rescanning technology, and product menu that spans from slides to servers.

纽约——随着其临床用数字病理系统在美国的推出，Epredia 旨在以其高通量扫描仪、自动重扫描技术和涵盖从切片到服务器的产品线赢得实验室的青睐。

The company

公司

recently announced

最近宣布

that it had secured US Food and Drug Administration 510(k) clearance for its E1000 Dx Digital Pathology Solution, which is comprised of its whole-slide imaging scanner, slide image viewer, and image management and viewing software. The system offers a throughput of 1,500 slides daily, including overnight scanning..

该公司的E1000 Dx数字病理学解决方案已获得美国食品药品监督管理局（FDA）510(k)许可，该解决方案包括其全切片成像扫描仪、切片图像查看器以及图像管理与查看软件。该系统每天可处理1500张切片，包括夜间扫描。

'It's a truly walkaway system,' Epredia President Steven Lynum said.

“它确实是一个完全独立的系统，”Epredia 总裁史蒂文·莱纳姆表示。

The company, the precision cancer diagnostics holding of PHC Holdings, is bolstering its digital pathology and immunohistochemistry instrument menus to meet an expected rise in demand for cancer testing. Formerly Panasonic Healthcare, PHC Holdings said in November that it expects a 5 percent compound annual growth rate for the Epredia business through FY 2027 as demand for complex pathology testing and workflow efficiency in labs is expected to contribute to growth in the pathology market..

该公司是PHC控股的精准癌症诊断部门，正在加强其数字病理学和免疫组织化学仪器的产品组合，以满足预期增长的癌症检测需求。PHC控股前身为松下医疗保健公司，去年11月表示，预计到2027财年，Epredia业务的年复合增长率将达到5%，因为对复杂病理测试和实验室工作流程效率的需求预计将推动病理市场增长。

The company said it plans to improve the quality of its offerings as well as compete on price as low-cost manufacturers enter the market. Lynum said that Epredia intends to become an innovator in cancer diagnostics, and it has been working toward that goal by developing reagents for personalized medicine, advanced digital pathology instruments, and artificial intelligence-driven technologies to streamline cancer diagnostics workflows..

该公司表示，随着低成本制造商进入市场，它计划提高产品质量并在价格上竞争。Lynum称，Epredia的目标是成为癌症诊断领域的创新者，并一直通过开发用于个性化医疗的试剂、先进的数字病理仪器以及人工智能驱动的技术来简化癌症诊断工作流程，朝着这一目标努力。

PHC reported last month that for the first nine months of 2024, Epredia's pathology revenues were up about 9 percent year over year to ¥43.2 billion ($280.8 million) from ¥39.6 billion with strong sales of consumables in the Americas and Europe, the Middle East, and Africa regions as well as positive currency exchange effects, although those gains were partly offset by sluggish equipment sales and lower revenues in China..

PHC上个月报告称，2024年前九个月，Epredia的病理学收入同比增长约9%，从396亿日元增至432亿日元（2.808亿美元），主要得益于美洲、欧洲、中东和非洲地区耗材销售强劲以及有利的汇率影响，但这些增长部分被设备销售疲软和中国收入下降所抵消。

PHC

PHC

reported last year

去年报告

that the Epredia business was in a turnaround phase that involved expanding sales in digital pathology, cutting costs, and improving the efficiency of its sourcing and manufacturing operations. The company said in November that the transformation is ongoing.

Epredia 业务正处于转型阶段，涉及扩大数字病理学销售、削减成本以及提高其采购和制造业务的效率。该公司在十一月表示，转型正在进行中。

Epredia, which is a shortened combination of the words 'enhancing precision diagnostics,' was formed from the anatomical pathology business that PHC bought from Thermo Fisher Scientific in 2019 in a

Epredia，是“enhancing precision diagnostics（提高精准诊断）”的缩写组合，由PHC于2019年从赛默飞世尔科技收购的解剖病理学业务组成。

$1.14 billion deal

11.4亿美元的交易

. PHC Holdings CEO Hidehito Kotani said at the time that Thermo Fisher's business had good potential to grow and create stakeholder value as part of the company's expanding diagnostics and healthcare portfolio.

PHC Holdings首席执行官Hidehito Kotani当时表示，作为公司不断扩展的诊断和医疗保健产品组合的一部分，赛默飞世尔科技的业务具有良好的增长潜力，并能为利益相关者创造价值。

In addition to the launch of the E1000 Dx, Epredia has been working with Hungarian firm 3DHistech on the development of a new immunohistochemistry instrument that combines technologies from both companies and will offer IHC staining, cover slip application, and slide digitization. The company has not announced an expected launch date..

除了推出E1000 Dx之外，Epredia还一直与匈牙利的3DHistech公司合作开发一款新的免疫组织化学仪器，该仪器结合了两家公司的技术，将提供IHC染色、盖片应用和玻片数字化功能。该公司尚未宣布预计的上市日期。

Epredia noted on its website that the E1000 Dx is also CE marked under the EU's In Vitro Diagnostic Regulation. While the company has been selling research-use-only scanners in the US since 2017, Lynum said that the firm had been missing an entry into the larger clinical market.

Epredia在其网站上指出，E1000 Dx也根据欧盟的体外诊断法规获得了CE标志。尽管该公司自2017年以来一直在美国销售仅用于研究的扫描仪，Lynum表示公司一直未能进入更大的临床市场。

Epredia Chief Strategy Officer Balazs Liposits said that only a minority of pathology labs have converted from microscopy-based pathology to the analysis of digital slide images, and E1000 is a plug-and-play solution that can help labs make that switch. However, he said that the system also offers high-throughput, low hands-on time, and high-quality images that are enticing for companies that are looking for new equipment..

Epredia首席战略官Balazs Liposits表示，只有少数病理实验室从基于显微镜的病理学转向数字切片图像分析，而E1000是一种即插即用的解决方案，可以帮助实验室实现这一转变。不过，他还指出，该系统还提供了高通量、低手动操作时间和高质量的图像，这对寻找新设备的公司来说非常具有吸引力。

He said that the company sees opportunities for the instruments in markets including North America, western Europe, and parts of the Asia-Pacific market including China, Australia, Japan, Hong Kong, and Singapore. With the recent 510(k) clearance, he said that the company has huge potential to build its business in the US.

他说，公司认为这些仪器在包括北美、西欧以及中国、澳大利亚、日本、香港和新加坡等亚太地区市场都有机会。随着最近的510(k)许可，他表示公司在美国有巨大的业务拓展潜力。

He said that the company hopes to increase interest in its E1000 Dx system through press releases, social media, and trade show appearances as well as demonstrations for potential customers by video conferencing. .

他说，公司希望通过新闻稿、社交媒体、贸易展览亮相以及通过视频会议为潜在客户进行演示，来增加对其E1000 Dx系统的兴趣。

Epredia’s push into the digital pathology space comes amid steady growth in adoption of digital pathology technology. The College of American Pathologists

Epredia进军数字病理领域之际，正值数字病理技术应用的稳步增长。美国病理学家协会

reported last year

去年报告

that 28 percent of pathology practice leaders surveyed had whole-slide imaging in their labs, up from 20 percent two years earlier. Companies and experts in the space see the potential with digitization to add lab capabilities through new tests, enable more collaboration with experts, improve the efficiency of slide examinations, and augment pathologists' analysis.

调查显示，28%的病理学实践负责人表示他们的实验室中配备了全片成像设备，比两年前的20%有所上升。该领域的公司和专家认为，通过数字化可以增加实验室的新检测能力，促进与专家的更多合作，提高玻片检查的效率，并增强病理学家的分析能力。

.

。

The prices of scanners, viewers, and software, though, have presented hurdles as costs can balloon into the millions of dollars for larger labs. Unlike the digitization of radiology, which allowed the direct capture and transmission of images, digital pathology adds costs because labs continue to produce glass slides for scanning..

然而，扫描仪、查看器和软件的价格成为了障碍，因为较大实验室的成本可能会膨胀到数百万美元。与允许直接捕获和传输图像的放射学数字化不同，数字病理学增加了成本，因为实验室继续制作玻璃幻灯片以供扫描。

As for Epredia's system, Liposits said that the E1000 Dx offers software-based capabilities including the integration of the image management system with laboratory information systems to allow the review of slides in combination with patient data, automated analysis of image sharpness and slide rescanning to reduce delays in diagnosis, and algorithm-based sample detection for faster scanning.

至于Epredia的系统，Liposits表示，E1000 Dx提供了基于软件的功能，包括将图像管理系统与实验室信息系统集成，以允许结合患者数据查看玻片、自动分析图像清晰度和玻片重新扫描以减少诊断延迟，以及基于算法的样本检测以实现更快的扫描。

Liposits said that the sample detection software is used to identify the borders of a sample and scan only the areas of the slide containing tissue, which also helps to reduce the size of whole-slide image files. He also noted that the company offers with the system a server to store slide images..

利波西茨说，样本检测软件用于识别样本的边界，并仅扫描包含组织的玻片区域，这也有助于减小全玻片图像文件的大小。他还指出，公司随系统提供了一台用于存储玻片图像的服务器。

Lynum said that bringing the E1000 Dx to market for clinical use completes Epredia's end-to-end digital pathology lineup that includes glass slides, stains, tissue processors, and microtomes, and he noted that growth in the digital pathology business is driving growth in those other businesses.

林纳姆表示，将E1000 Dx推向市场用于临床，完善了Epredia公司的端到端数字病理产品线，该产品线包括玻片、染色剂、组织处理器和切片机等。他指出，数字病理业务的增长正推动其他相关业务的增长。

'We're able to offer the full package to the pathologist, from start to finish,' he said. 'Anything you need in that laboratory, we're able to provide, and that gives them the opportunity to standardize and improve their quality and to make better and more timely diagnoses.'

“我们能够为病理学家提供从头到尾的全套服务，”他说。“实验室里需要的任何东西，我们都能提供，这使他们有机会实现标准化、提高质量，并做出更好、更及时的诊断。”