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.
The company recently announced 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.
"It's a truly walkaway system," Epredia President Steven Lynum said.
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.
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.
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 reported last year 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, 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 $1.14 billion deal. 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.
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.
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 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.
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. 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.
Epredia’s push into the digital pathology space comes amid steady growth in adoption of digital pathology technology. The College of American Pathologists reported last year 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.
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.
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. 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.
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.
"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."