NEW YORK – Anticipating a breakout moment in digital pathology, precision cancer diagnostics company Epredia has been preparing by bolstering its lineup of instruments used in sample processing workflows as well as partnering with software firms on image analysis using the firm's whole-slide scanners.
Epredia President and CEO Steven Lynum said that the effort includes working with the company's partner, Hungarian firm 3DHistech, on the development of a new instrument that combines sample preparation and scanning steps. He said that the instrument could help labs to simplify their workflows and improve the consistency and quality of their samples. Improving the reliability of sample preparation upstream from scanning is necessary for digital pathology to take off, he said.
The company became the precision cancer diagnostics business of PHC Holdings, formerly Panasonic Healthcare, in 2019 through PHC's $1.14 billion acquisition of Thermo Fisher Scientific's anatomic pathology division.
PHC reported last month that the Epredia business was in the midst of a turnaround, with a particular focus on expanding its sales in digital pathology. The business had been cutting costs and making changes to its sourcing and manufacturing operations to improve efficiency as well as lowering its SG&A costs. The firm reported that Epredia's revenues grew 8 percent during the first nine months of fiscal year 2023, to ¥39.6 billion ($266 million) from ¥36.5 billion one year earlier.
Since the 2019 acquisition, Lynum said Epredia has made its biggest investments in the digital pathology and immunohistochemistry markets.
"We realized that by investing into those areas, we're able to enhance precision diagnostics by helping pathologists do their job much more efficiently," he said.
Lynum said that the firm offers a unique array of end-to-end instruments for pathology workflows including tissue processors, microtomes, embedding stations, and a range of 3DHistech-developed whole-slide scanners from the single-slide Pannoramic Desk II to the flagship Pannoramic 1000 scanner that has a 1,000-slide capacity and throughput of 100 slides per hour or 2,000 slides per day, including overnight scanning.
While the scanners are certified under the EU's In Vitro Diagnostics Medical Devices Regulation for use in Europe, those instruments are currently research use only in the US. The firm was not able to provide a timeline for when the instruments could become available for clinical use in the US.
The Epredia name, coined five years ago, is an abbreviation and combination of the words "enhancing precision diagnostics," though Lynum said Epredia as an entity has been around in some form for the past 85 years. The firm produces about 1 billion glass slides each year, and it ships stains worldwide from its offices in Kalamazoo, Michigan.
"We're sold in over 120 countries, and every second, 44 of our products are used," he said.
In 2021, Epredia announced that it had inked a deal to become a global distribution partner for Aiforia's portfolio of artificial intelligence-developed preclinical and clinical pathology software, including exclusive distribution rights in the US, UK, Denmark, France, Germany, Iceland, Italy, Japan, Norway, Spain, and Sweden.
That year, the firm also became a global distribution partner for Paige's lineup of AI-based diagnostic software, with exclusive distribution rights in Japan. Lynum said Epredia's investments in those digital pathology software firms has led to a surprising uptick in demand for the company's longstanding sample processing tools.
As for clinical labs that are adopting digital pathology, Lynum said that they get the most for their money by investing in the instruments that will feed accurate, high-resolution data into the AI-based software, and delivering consistent high-quality samples has been a focus area for Epredia under PHC.
According to Lynum, the firm aims to soon deliver tools that can further improve efficiency and reliability by automating or eliminating routine processes, which would let technicians focus on more important tasks.
To that end, Epredia and 3DHistech jointly established last year in Budapest the Pathology Innovation Incubator with a goal of developing complex combined medical technologies for immunohistochemistry-based cancer testing. Lynum estimates that by early 2025, research labs will be able to use for the first time an instrument that combines IHC staining, cover slip application, and slide digitization.
"I think we will continue to invest heavily into new products. I believe very strongly in combining equipment to streamline the upstream workflow," he said.
Competitors in the digital pathology space who are offering their own solutions to the pressures on pathologists include Philips, which also offers streamlined end-to-end workflows through the Philips IntelliSite Pathology Solution that incorporates high-throughput scanners, software, IT configuration, and integration with interoperability with laboratory information systems.
Also, Proscia announced this month that it has formed an alliance aimed at improving the interoperability of hardware and software combinations from partner vendors. Lastly, Roche has been offering since 2018 high-speed scanners with automated pathology workflows, and the firm said last month it had inked a partnership with PathAI that is focused on AI-based development of companion diagnostic solutions.
About 80 percent of Epredia's business comes from clinical labs, although Lynum aims to increase the volume that comes from research by targeting efficiency and sample preservation needs. He said the company sees unmet need for the firm's Revos tissue processor that uses proprietary low-heat methods to improve DNA and RNA retention in samples, which he said can allow the use of samples in subsequent studies years to decades later as new biomarkers are discovered.
The firm also has room to grow sales in pharmaceutical and academic research of the firm's automated tissue microarrayers that the company sells through its partnership with 3DHistech. Epredia has also recently launched new printers for slide identification and tracking.
Lynum said that the firm has also been working to make sure that its equipment sold in clinical and research markets alike are widely compatible with the equipment combinations found in labs. As the company has been developing its upcoming scanner that incorporates sample prep steps, he noted that the firm has also been investing into optimization of the device software so that it will offer plug-and-play compatibility with a variety of laboratory information systems as well as AI-backed software platforms.
Lynum said that Epredia wants to give customers access to its equipment and let them choose how it should fit into their labs.