Hello LinkedIn, I hope 2025 is off to a fantastic start for everyone!
Before diving into industry updates, I’m excited to share some internal news: the Diagnostics and Life Sciences team at Signify Research has welcomed a new member! Elizabeth Bourn has joined me to support our work as we expand our coverage of the digital pathology ecosystem. Feel free to connect with her as she reaches out over the coming months as part of our latest research efforts. ??
With that, here’s January’s Digital Pathology news round-up:
- At the end of last month, Owkin shared findings from a July 2024 survey of 312 pathologists and oncologists across the United Kingdom, United States, and France. The report is well worth a read, and I encourage you to check it out. One key takeaway that stood out to me was that nearly two-thirds of pathologists and oncologists believe that implementing AI in pathology will not only accelerate oncologists’ review of tests but also reduce treatment waiting times. Signify Research Ltd recently conducted an end-user survey study for a client which revealed similar enthusiasm for AI among pathologists. However, this enthusiasm was tempered by considerations around budgeting priorities, suggesting that while widespread AI adoption is on the horizon, it may take some time to fully materialise... If you're interested in learning more, our decision-maker primary research work led by Rohinee Lal, with support from Tamzen Brenton and Adam Bolton, offers clients the opportunity to conduct surveys targeted at digital pathology end-users. This enables deeper insights that may not be uncovered through vendor-focused research, so please feel free to reach out to them if you’d like to explore what else we can offer.
- Next, we have some significant news from Paige, which reported that its FullFocus? digital pathology image viewer received 510(k) clearance from the US Food and Drug Administration (FDA) for use with two additional scanners: the Leica Aperio GT 450 DX (supporting SVS and DICOM file formats) and the Hamamatsu Corporation's NanoZoomer S360MD (supporting the NDPI file format). Previously, the viewer had been cleared for use with the Philips IntelliSite Pathology Solution (PIPS) Ultra Fast Scanner. While Philips has a significant number of scanners installed across the US, the FDA approval process is still under a 'closed loop' system, meaning specific software is tied to specific scanners. As the US competitive market evolves, this expanded approval will allow Paige to remain adaptable and broaden its addressable clinical base. In similar news, Roche announced that its VENTANA DP 600 slide scanner received FDA 510(k) clearance as part of the Roche Digital Pathology Dx system. This scanner can process up to 240 slides, surpassing the capacity of the previously approved model, indicating that Roche is actively preparing to expand its commercial presence in the US clinical market.
- Shifting our focus, HistoWiz last week announced the integration of AI tools from Aiosyn and AIRA Matrix Private Limited into its PathologyMap platform. Histowiz targets research markets with its services and products, where the use of AI is much more common. Offering third-party options is a smart way to position the platform as a one-stop solution for image analysis, however, we've seen fewer partnerships in research environments compared to clinical markets. That said, I expect we'll see more AI partnerships like this in the research space moving forward.
- Fourth on my list is an acquisition! Quanterix will acquire Akoya Biosciences, Inc. in a merger agreement concluding in the second quarter of 2025. For those unfamiliar, Akoya Biosciences develops imaging tools to help researchers understand spatial biology. This decision makes sense strategically, as the transaction will create the first integrated solution for the combined detection of blood- and tissue-based protein biomarkers, enabling both companies to leverage upselling opportunities within their existing customer bases. Recently, vendors in digital pathology have also been assessing the timeline for the adoption of multiplex imaging in clinical practice, although likely low-plex. Although significant adoption is not expected in the near term, vendors like Akoya Biosciences will soon start to explore opportunities in clinical settings.
- Next, Biomy, Inc. and the NEC Corporation have partnered to develop and expand the former's AI-based analytical platform. Combined, the two will provide the platform, biomarker discovery services, and regulatory guidance to pharma/biotech and academic institutions. Digital CDx discovery in whole slide images has gained significant momentum in recent months, with a few public announcements on this topic towards the end of last year. This theme is expected to persist in 2025 as projects begin to mature and pharma starts considering its deployment strategy in clinics. If your company is exploring the optimal way to deploy CDx algorithms in clinical settings, please feel free to reach out. Signify Research's digital pathology market intelligence and installed base analysis could provide valuable insights to support your efforts!
- At this year's J.P. Morgan conference the Mayo Clinic announced the launch of the 'Mayo Clinic Digital Pathology' platform. Also announced was a partnership with?NVIDIA to provide access to the latter's technical expertise and resources, as well as a collaboration with Aignostics. The Mayo Clinic announced some time ago that it was digitising its archived slides so it should come as no surprise that it intends to leverage this resource! In fact, the collaboration with Aignostics has already resulted in a foundation model built on 1.2M slides worth of data, findings of which were published in a?paper?this month. With such a rich source of real-world data (RWD) at its disposal, further publications, partnerships, and research initiatives are expected.
- Next, congratulations to Deciphex which recently announced it has secured $32.3M in Series C funding. The round was led by Molten Ventures, with significant participation from Act Venture Capital, Seroba., Charles River Laboratories, IRRUS Investments, HBAN MedTech Syndicate, and NextSteps Capital. This investment will support the company's global expansion, platform development, and the development of new AI models for clinical and non-clinical applications. And the company has already launched Diagnexia Analytix, a pathology service specifically designed for the drug development industry. With the IMS market remaining highly competitive, the landscape is still wide open for growth and innovation, and additional funding rounds from competitors are expected to be announced later this year.
- Another piece of news that caught my eye this month was that PathChat DX, Modella AI's generative AI co-pilot has received FDA Breakthrough Device Designation. PathChat DX is an extension of the PathChat model that was published in Nature and developed in the Mahmood Lab at Mass General Brigham. Something to bear in mind is that FDA Breakthrough Device Designation does not imply FDA clearance or approval, and the product is currently undergoing further testing. Furthermore, this designation does not ensure future regulatory approval, with only about 10% ultimately succeeding. The key takeaway is to stay informed while approaching generative AI with a measured level of caution.?
- Following the theme of generative AI, this month Bioptimus also announced a significant funding round of $41M led by Cathay Innovation. This brings the company's total to $76M less than a year from its initial seed round. While the number may seem high, Bioptimus is targeting the medical, biotech, and cosmetic industries, with the biotech sector showing significantly higher digital imaging adoption compared to clinical settings. Its flagship product, H-Optimus-0, has achieved impressive results when benchmarked against competitor solutions, but the company also plans to launch a new multi-scale, multi-modal foundation model in 2025. Generative AI has been making waves in digital pathology for some time, eliciting both enthusiasm and scepticism from industry stakeholders. However, when it comes to commercial implications, it's important to recognise that accuracy/superior results alone are often not the defining factors for success — effectiveness in real-world clinical settings plays a crucial role, a consideration that some vendors may overlook.
- Finally, Leica Biosystems announced a significant strategic investment in Indica Labs to combine Leica's Aperio scanner portfolio with a customised version of Indica's HALO AP image management software. The partnership will also integrate Indica Labs into the Leica Biosystems' CDx development programme. While not a full acquisition, it positions Indica Labs as a potential future exit opportunity. Given that Leica's software is slightly outdated and will require modernisation to support higher volume growth, a key question remains: how will the company address interoperability, especially as the market increasingly prioritises it?
That's all for this month but do subscribe to receive regular updates!
Signify Research has been tracking the digital pathology market since 2017, and now interviews >150 stakeholders in the ecosystem as a part of our research every year. This includes not only digital pathology vendors but also pharmaceutical companies, CROs, pathologists, IT infrastructure companies, and adjacent LIS and radiology Healthtech vendors to provide as comprehensive an analysis as possible.
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Imogen joined Signify in 2018 as part of the Healthcare IT team. She holds a 1st class Biomedical Sciences degree from the University of Warwick. Since joining the team Imogen has studied various healthcare markets and is now expanding Signify Research’s coverage in Diagnostic and Life Science markets. She has published reports on Breast Imaging, General Radiography, AI in Drug Development and Clinical Trials, LIS/LIMS, digital pathology, oncology IT, and Real-World Data.
The Diagnostics and Lifesciences team provides market intelligence and detailed insights on the multiple healthcare technology markets where the clinical world intersects with the preclinical. Our areas of coverage include digital pathology, laboratory information systems, clinical Real-World Data (cRWD) platforms, oncology information systems, tumour board software, oncology decision support software and radiotherapy IT. Each report provides a data-centric and global outlook of its markets with granular country-level insights. Our research process blends primary data collected from in-depth interviews with healthcare professionals and technology vendors, to provide a balanced and objective view of the market.
Signify Research provides healthtech market intelligence powered by data that you can trust. We blend insights collected from in-depth interviews with technology vendors and healthcare professionals with sales data reported to us by leading vendors to provide a complete and balanced view of the market trends. Our coverage areas are Medical Imaging, Clinical Care, Digital Health, Diagnostic and Lifesciences and Healthcare IT.
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3 周Great roundup of the latest innovations in digital pathology and healthcare! It’s exciting to see how companies like Owkin, Paige, and Quanterix are driving real-world data integration and precision medicine forward. Looking forward to staying updated on these developments!