Digital-Pathology-Today

Here is the August Digital Pathology Roundup with Imogen Fitt of Signify Research. 1. Acquisitions: Tempus AI is buying Paige for $81.25M, mostly in stock. Beyond headlines calling it a “data deal,” Tempus gains Paige’s ~7M de-identified whole-slide images plus seasoned AI/regulatory assets: Paige holds FDA Breakthrough Device Designations and De Novo clearances across prostate, lymph node, and PanCancer Detect. Tempus will also assume Paige’s existing Microsoft Azure cloud commitment. Microscope maker Evident acquired AI-enabled scanner vendor Pramana—the first notable scanner-vendor acquisition in a while—prompting fresh questions about how hardware and AI stacks will consolidate. 2. Partnerships: China’s Thorough Future announced a strategic partnership with Leica Biosystems to bring its multi-organ tumor-detection model (lung, stomach, prostate, intestine, lymph nodes) into Leica’s software; details remain light. KFBIO struck a distribution deal with Malaysia’s CytoVision to bring KFBIO’s scanners, AI, and software to Singapore and Brunei. CytoVision, active since 2023 in digitization and education, already works with two Singaporean hospitals, positioning KFBIO for regional traction. Techcyte extended its integration spree: (1) Modella AI’s PathChat co-pilot (and research-only PathChat DX, which has FDA Breakthrough status) to help pathologists summarize reports, interpret images, and query slides; and (2) DeepBio’s prostate and frozen-section algorithms. Initial DeepBio integrations will be RUO, with CE-IVD offerings in the portfolio and U.S. access planned via CLIA labs. 3. Regulatory: ArteraAI secured FDA De Novo authorization for ArteraAI Prostate just 35 days after announcing Breakthrough Device status. It is now the first FDA-authorized AI tool to provide prognostic insights for patients with non-metastatic prostate cancer, and the decision creates a new product code that may streamline pathways for follow-on entrants.

Here is the July 2025 Digital Pathology Roundup with Imogen Fitt of Signify Research. Partnerships: Owkin launched a 5-year partnership with Newcastle Upon Tyne Hospitals NHS Foundation Trust to apply agentic AI across drug discovery, development, and diagnostics. First up: an AI tool to screen for gBRCA mutations in breast cancer, with Newcastle running validation studies and contributing multimodal data via Owkin’s ATLANTIS network (20 institutions across 7 countries, 11 therapeutic areas. Lunit teamed with Microsoft to broaden access to cancer-detection AI through Azure-based model fine-tuning and agentic workflow tools; this follows Lunit’s growing DP footprint (e.g., SCOPE PD-L1 TPS integrating with Roche’s platform). AIVIS and AstraZeneca Korea signed an MoU to build an AI-driven HER2 diagnosis ecosystem, clinically implementing AIVIS’ Qanti IHC under the newer, more granular HER2 classification. Regulatory Milestones: Artera received FDA Breakthrough Device Designation (BDD) for ArteraAI Prostate, the first AI risk-stratification tool in prostate cancer predicting metastasis risk and disease-specific mortality from WSIs. CDx Diagnostics also earned BDD for WATS3D, which uses AI on 3D digital pathology images obtained via a proprietary brush for Barrett’s esophagus, dysplasia, and esophageal cancer—run in CDx’s CLIA/CAP/NYS-licensed lab. Other 2025 BDDs include Paige (PanCancer Detect), Roche (VENTANA TROP2 RxDx), and Modella AI (gen-AI co-pilot). Reminder: BDD is not clearance; historically only ~10% progress to full FDA clearance. AI Developments: Google Research/DeepMind expanded MedGemma with MedGemma-27B Multimodal (including EHR interpretation) and MedSigLIP (lightweight image–text encoder) spanning radiology, dermatology, digital pathology, ophthalmology; MedGemma integrates FHIR and medical text. A joint study showed illumiSonics’ MLI can generate virtual H&E-like images from unstained skin tissue that Modella AI’s PathChat DX (without prior virtual-histology training) could analyze with high concordance versus eight dermatopathologists reviewing virtual and matched chemical H&Es—signaling growing momentum for stain-free imaging. Funding: Imagene raised a $23M Series B led by Larry Ellison and Oracle. Scopio Labs unveiled its Complete Blood Morphology analyzer to automate peripheral smear review and analyze ~10× more cells than current practice; Viola Growth added $10M to Scopio’s Series D. Earlier in July, Scopio gained FDA clearance for a Decision Support System on X100/X100HT and a Peripheral Blood Smear app with AI-driven RBC morphology grading.

The June Digital Pathology Roundup with Imogen Fitt of Signify research is here. Funding: • RainPath AI raised €2.5M from Teampact.ventures, Xplore by Épopée Gestion, The Quest, Advance Lab, SHARPSTONE, about 15 angels, and Bpifrance. RainPath builds AI tools for virtual staining, smarter slide analysis, and structured reporting to cut reagent use and ease diagnostic bottlenecks. Funds will double headcount and advance product development and clinical validation. • PreciseDx closed $11M led by Eventide, Merck GHI, and Philips Ventures, with Labcorp, Quest, GenHenn, and others. Eric Converse was named CEO and Ed Sitar CFO. Proceeds support more clinical data, commercial expansion, and prep for a 2026 launch of PreciseBreast, which provides phenotypic and grading insights to predict breast cancer recurrence risk. Regulatory: • PathPresenter received FDA 510(k) for its Clinical Viewer for primary diagnosis, cleared with Hamamatsu NanoZoomer S360MD NDPI images on a Barco NV MDPC8127 display. Broader device and file support is expected. • PathAI secured FDA 510(k) for AISight Dx IMS for primary diagnosis with Hamamatsu S360MD and Leica Aperio GT 450 DX scanners; the IMS was first cleared in 2022 with the Philips Ultra-Fast Scanner. The FDA also approved a Predetermined Change Control Plan PCCP, allowing PathAI to add displays, scanners, file formats, and browsers without new 510(k) submissions, speeding platform expansion. • Evident announced that SLIDEVIEW™ DX VS200 earned the CEIVDR mark in Europe. The scanner supports fluorescence, polarization, darkfield, and phase contrast, adding competitive choice in Western Europe. Partnerships: • PathPresenter and CAP unveiled an immersive AI platform for CAP members to trial tools from multiple vendors, launching at CAP25 Sept 13 to 16, Orlando. • GI Alliance will adopt Lumea Viewer+ for its digital pathology entry, a significant deployment across 900 gastroenterologists and 400 plus sites. • Leica extended its CDx collaboration with Bristol Myers Squibb. Parent Danaher formed another CDx partnership with AstraZeneca. • Paige partnered with the Breast International Group to evaluate OmniScreen, focusing on novel biomarkers and real-world performance, especially in rare breast cancer subtypes. Paige also integrated with Roche Navify Digital Pathology.

Here is May's Digital Patholog Roundup with Imogen Fitt of Signify Research. 1. Digital Pathology as a Service (DPaaS): Histofy and Source BioScience announced a strategic partnership to enhance diagnostic workflows, starting with efficiency improvements and later expanding to deploy Histofy’s AI tools across Source’s UK-wide operations. Notably, Source BioScience is the UK’s largest histopathology provider and had previously acquired LD Path in 2022. This move reinforces the emerging trend of service-based digital pathology models, as seen with Inify Laboratories and PathologyWatch. 2. Platform Integrations: French AI company Bioptimus launched its H-optimus-1 model on AWS Marketplace, improving accessibility for life sciences. Meanwhile, Labcorp introduced an integrated digital pathology platform across its central labs, combining Leica Biosystems’ Aperio GT450 scanners with Proscia’s Concentriq LS system. The initiative aims to streamline scanning, archival, and companion diagnostic development for global clinical trials. 3. Artificial Intelligence: At Microsoft’s #Build2025, the company launched its Healthcare Multi-Agent Orchestrator, which includes Paige's Alba co-pilot for image-based pathology queries. Additionally, PictorLabs partnered with PathPresenter to integrate AI-based virtual staining into PathPresenter’s platform. Users can now apply virtual H&E, IHC, and special stains instantly on whole slide images for education, research, and clinical use—though FDA approval is still pending for PictorLabs’ solution. 4. Funding: Medmain Inc. raised $3.3 million to enhance its PidPort image management system, expand infrastructure, and pursue regulatory approval for its AI tools. This brings 2025’s total Digital Pathology VC funding to $168 million across 10 vendors, reflecting strong investor interest.

April’s Digital pathology Roundup with Imogen Fitt of Signify Research reflects strong momentum in digital pathology integrations, global AI expansion, and regulatory milestones. Partnerships & Integrations: Visiopharm + Indica Labs: Visiopharm’s Discovery image analysis software is now integrated into Indica Labs’ HALO Link (v4.1) platform. This paid add-on allows seamless viewing of annotations, ROIs, and analysis summaries across platforms. Paige + Burjeel Holdings: Paige’s AI solutions will be deployed across Burjeel’s 100 healthcare facilities in the MENA region (UAE, Saudi Arabia, Oman), expanding access to AI-powered pathology. Paige + Sectra: Sectra will distribute Paige’s AI tools, enhancing Sectra’s digital offerings in radiology, cardiology, and pathology. Mindpeak + DigitCells: Mindpeak’s AI algorithms will be integrated into DigitCells’ platform to enhance pathology automation. Google Cloud + Endeavor Health: New cloud-based platform aims to accelerate diagnosis, facilitate second opinions, and enable direct patient-pathologist engagement by allowing patients to view images and consult with pathologists. Regulatory Approvals: VIEWORKS: Korea’s VIEWORKS received CE IVDR certification for its VISQUE DPS LH510 scanner (supports tissue & cytology). The company plans European expansion. Roche: FDA granted Breakthrough Device Designation to Roche’s VENTANA® TROP2 CDx—first digital pathology companion diagnostic to receive this designation. Funding: Gestalt Diagnostics: Raised $7.5M Series A (total $12M) led by Cowles Ventures and others. Funds will accelerate AI development, commercialization, and FDA approval efforts. Leidos + Univ. of Pittsburgh: Leidos committed $10M over 5 years to fund the Computational Pathology Center, advancing research and clinical AI applications. Clinical Pilots: Region Skåne (Sweden): Initiated proof-of-concept for Paige’s Prostate Suite. Success may drive broader regional adoption. Listen to Digital Pathology Today on all major podcast platforms.

March saw major developments across digital pathology, including regulatory milestones, foundational AI models, strategic partnerships, and significant funding wins. Regulatory Approvals: Epredia earned FDA 510(k) clearance for its high-volume E1000 Dx Digital Pathology Solution, capable of digitizing up to 1,500 slides per day. Despite the hardware’s impressive capacity and features like dual slide processing and automated quality control, its immediate clinical appeal may be tempered by institutions’ preference for redundancy over sheer throughput. Still, Epredia’s longstanding customer trust and emphasis on quality may help drive early adoption. Meanwhile, PathAI received EMA qualification for its AIM-MASH AI tool, which standardizes biopsy scoring for MASH trials—well timed given the FDA’s recent approval of the first drug for the condition. Foundation Models & Large Datasets: Bioptimus launched ‘H-optimus-1,’ a massive pathology foundation model trained on over 1 million H&E slides from 800,000+ patients. It more than doubles the dataset used for their previous model and builds momentum following January’s major funding round. At HIMSS, HistAI debuted its SPIDER initiative, aiming to create a 50-million-image open-source dataset covering 20 organs. The first release includes 3 pretrained models targeting skin, colorectal, and lung—an ambitious step toward accelerating AI discovery and collaboration. Partnerships: Quest Diagnostics teamed up with Google Cloud to deploy generative AI for enhanced data analytics and customer experience. While not immediately diagnostic, such tools are paving the way for future clinical AI applications. Funding: Proscia raised $50 million in a round led by Insight Partners, boosting its total funding to $130 million. The funds will support platform adoption, AI enhancements, and deeper collaborations with Agilent and Siemens. The company also hinted at a future IPO—marking a promising trajectory for this digital pathology innovator.

February 2025 saw significant momentum in Digital Pathology, marked by strategic partnerships, platform expansions, and regulatory progress. Here is the February Round-up with Imogen Fitt of Signify Research. Indica Labs partnered with Versant Diagnostics to deploy the HALO AP platform across U.S. labs, emphasizing usability, collaboration, and AI integration. Despite FDA approval for the NanoZoomer S360MD scanner, implementation remains complex due to diverse installed scanner bases. Deciphex extended its partnership with Charles River Laboratories, integrating its Patholytix platform to manage toxicologic pathology data. Building on its Foresight AI, Deciphex aims to enhance lesion and tissue coverage, strengthening its dominance in pharma toxicology. In Digital Pathology–Genomics integration, Myriad Genetics and Lumea teamed up to streamline test ordering through Lumea’s platform, mirroring global trends toward centralized diagnostic systems. Additionally, Imagene and ArteraAI partnered with Tempus AI to distribute AI-powered assays, bypassing adoption barriers and potentially accessing Tempus' real-world datasets. These moves hint at deeper integration and potential acquisitions in the future. AI portfolio expansion continued, with Paige’s PanCancer Detect growing to cover 40+ tissue types, fueled by Virchow V2 (trained on 3.1M slides). Paige also secured 510(k) clearance for more scanners and increased accessibility via key platforms, signaling renewed clinical focus. Regulatory approvals were a highlight: Ibex Medical Analytics earned its first FDA 510(k) clearance for Prostate Detect, positioned as a safety net for pathologists. Meanwhile, Aiforia Technologies received IVDR certification in Europe, launching new CE-IVD models targeting breast and prostate cancer diagnostics. Finally, Sectra announced a digital pathology pilot with William Osler Health System in Ontario, part of a decade-long enterprise imaging strategy. Integration with existing IT systems is increasingly seen as critical, as vendors aim for long-term growth through enterprise imaging tenders globally.

Here is January’s Digital Pathology round-up with Imogen Fitt of Signify Research. FDA Clearances: Paige received FDA 510(k) clearance for its FullFocus™ digital pathology viewer to support additional scanners, the Leica Aperio GT 450 DX and the Hamamatsu NanoZoomer S360MD. Previously cleared for the Philips IntelliSite Pathology Solution, this approval expands Paige’s flexibility in the competitive U.S. market. Similarly, Roche’s VENTANA DP 600 slide scanner gained FDA clearance, boasting a 240-slide capacity, surpassing its predecessor and strengthening Roche’s commercial positioning in the U.S. FDA Breakthrough Designations: Modella AI’s PathChat DX, a generative AI co-pilot for pathology, received FDA Breakthrough Device Designation. Developed at Mass General Brigham’s Mahmood Lab, PathChat DX builds on previously published research in Nature. However, this designation does not imply FDA clearance or guarantee future approval, with only 10% of such designations historically succeeding. The news underscores the growing role of generative AI in pathology while cautioning against premature assumptions about regulatory success. Platform Integrations: HistoWiz integrated AI tools from Aiosyn and AIRA Matrix into its PathologyMap platform, targeting research markets where AI adoption is more widespread. Unlike the clinical sector, research environments have seen fewer AI partnerships, but this move signals a trend toward broader AI collaborations in pathology research. Funding: Deciphex raised $32.3M in Series C funding, led by Molten Ventures and others, to support global expansion, platform development, and new AI models. The company also launched Diagnexia Analytix for drug development pathology. Meanwhile, Bioptimus secured $41M, bringing its total to $76M in under a year. Targeting biotech, medical, and cosmetic industries, Bioptimus plans to launch a new multi-scale, multi-modal foundation model in 2025. While AI advancements continue to generate excitement, commercial success depends on real-world clinical efficacy beyond just superior accuracy.

Imogen Fitt from Signify Research joins us for her predictions for Digital Pathology in 2025. Trend 1 – Genomics and Digital Pathology Markets Becoming Inextricably Linked Genomics and digital pathology are converging as distinct yet complementary fields. Increasingly, vendors are developing solutions that bridge the gap between these areas—for example, algorithms are being commercialized to extract genomic biomarkers directly from digital pathology images. Pharmaceutical companies are also collaborating with diagnostic and imaging firms, integrating multi-modal data from whole slide images to create digital companion diagnostics. Furthermore, strategic partnerships and investments (e.g., between molecular diagnostics firms and digital pathology vendors) are helping to merge the two fields. This integration not only enhances personalized medicine by providing a more comprehensive view of patient physiology but also improves laboratory workflows and pre-screening processes. Regions like Northern Europe have already started incorporating genomic data into digital pathology information management systems, demonstrating the growing market demand for such integration. Trend 2 – Generative AI Boosting Lab Productivity Generative AI (GenAI) is beginning to reshape lab operations by enhancing productivity and efficiency. Health tech and life sciences companies are actively exploring GenAI applications to automate report generation, consolidate knowledge, and streamline audit and quality control processes. Early initiatives from leading institutions like the Mayo Clinic and companies such as Sanofi illustrate the experimental use of GenAI in laboratory settings, particularly within digital pathology image analysis. Although the commercial impact of GenAI remains in its early stages, its potential to reduce manual tasks and enhance operational workflows is becoming increasingly recognized, indicating that GenAI will soon play a vital role in laboratory productivity improvements. Trend 3 – Continued Consolidation in the Marketplace The healthcare technology market is witnessing ongoing consolidation as vendors seek to strengthen their market positions by acquiring complementary businesses. This trend is driven by the need to expand capabilities and streamline product offerings, allowing companies to better meet the evolving demands of the industry. Such acquisitions enable vendors to combine expertise, reduce redundancies, and create more integrated solutions, thereby accelerating innovation and market penetration. Trend 4 – Digital Pathology’s Clinical Growth Driven by Adjacent Stakeholders and Vendor Types Although clinical adoption of digital pathology is still emerging, growth is being propelled by stakeholders from adjacent markets. BigTech companies—such as AWS, Microsoft, Google, and Dell—are entering the space, drawn by the revenue potential of whole slide image storage and real-world data management. Pharmaceutical firms are strategizing to secure reimbursement for digital companion diagnostics and exploring deployment models that integrate low-throughput pathology scanners in clinical settings. Additionally, radiology vendors are advocating for standardization efforts (like DICOM and Vendor Neutral Archives), which facilitate the integration of digital pathology systems with broader enterprise imaging platforms. New players in microscopy, laboratory information management systems (LIMS), teleradiology, and image exchange further underscore the expansive growth trajectory of digital pathology. Overall, while challenges remain, these four trends illustrate a dynamic and transformative future for healthcare, promising significant advancements in patient care, research, and operational efficiency.

Happy Holidays Everyone! Here is the Digital Pathology Round-Up covering events in November with Imogen Fitt of Signify Research. There will be no December roundup but rather an assessment of the state of the industry and Predictions for 2025 coming in January. Customer Expansions: Ibex Medical Analytics announced significant expansions with existing customers. Alverno Laboratories, operating in Illinois and Indiana, launched Ibex’s AI-based breast cancer diagnostic platform, building on its earlier adoption of prostate diagnostics. A gastric platform is also in development. Meanwhile, France’s Institut Curie deployed Ibex’s prostate solution, with further expansions planned. These updates highlight the slow but steady adoption of AI in pathology, reinforcing its value despite lengthy validation processes. Partnerships: OptraSCAN secured $30M in Series B funding, led by Molbio Diagnostics, to accelerate R&D, expand global sales, and enhance AI pathology tools. Partnerships between genomics and digital pathology firms are expected to deepen as AI solutions advance. Lunit Oncology also announced a collaboration with AstraZeneca to develop AI-powered digital pathology tools for assessing non-small cell lung cancer (NSCLC) risks. Using Lunit’s SCOPE Genotype Predictor, this partnership focuses on identifying key mutations, marking Lunit’s first direct deal with a global pharmaceutical company. Third-Party Integrations: Owkin launched its MSIntuit CRC v2 test for colorectal cancer screening on Proscia’s Concentriq platform and joined the Proscia Ready alliance. The focus now shifts to the implementation of these integrations, whether as pop-ups or embedded tools, and the timeline for deployment. PathAI also announced the integration of tools from Deep Bio, DoMore Diagnostics, Paige, and Visiopharm into its AISight platform. With many IMS platforms adding third-party AI tools, differentiation strategies for vendors in an increasingly crowded market remain a key question

Imogen Fitt from Signify Research joins us for the October Digital Pathology Roundup, which highlights significant developments in digital pathology and related fields, focusing on funding, telepathology, generative AI, and enterprise imaging. Funding: Mindpeak GmbH secured $15.3 million in Series A funding led by ZEISS Ventures and other notable investors, aiding product development and geographic expansion. Aignostics raised €31.4 million in Series B funding, backed by Athos Partners and Mayo Clinic Ventures, to enhance its platform for translational research and companion diagnostics, following a partnership with Bayer. StratifAI obtained €1.5 million in pre-seed funding from Neulogy Ventures and others to support digital biomarker development for breast cancer and biopharma services. Telepathology Services: Inify Laboratories announced its expansion into the UK market, focusing on prostate cancer diagnostics, backed by SEK 150 million funding to develop AI for gastrointestinal diagnostics. Originally part of ContextVision AB, Inify pivoted to telepathology using AI. In the US, NorDx adopted PreciPoint's Advanced Digital Pathology Solutions for frozen section diagnostics, emphasizing AI’s role in improving diagnostic turnaround times, a trend supported by investments from major players like Quest Diagnostics. Generative AI: Proscia introduced "Concentriq Embeddings" and a Developer Toolkit to assist AI development for life sciences. These tools use foundation models like DINOv2 and ConvNext to generate data embeddings from slide images, enabling customized AI workflows and integration. Enterprise Imaging: Gestalt partnered with Optum to integrate its PathFlow solution into Optum’s Enterprise Imaging Suite. This collaboration, involving Change Healthcare (acquired by Optum), represents a strategic move to advance digital pathology within enterprise healthcare platforms.These advancements underline the growing role of AI and digital solutions in pathology, fostering innovation and collaboration across the industry

September's round-up highlights significant advancements in AI integration, structured reporting, real-world data (RWD), hematology, and funding in the digital pathology space. Aiforia Technologies partnered with Assistance Publique–Hôpitaux de Paris (AP-HP) to introduce AI-based prostate solutions into clinical use, backed by regional funding from Île-de-France. This initiative aims to study AI's impact in clinical care, with the potential for broader AI implementation across France, as AP-HP plans to expand AI usage across all its pathology departments. Proscia and Smart Reporting GmbH also joined forces, integrating SmartReports, a structured reporting tool, into Proscia’s Information Management System (IMS). Structured reporting enables the generation of standardized medical reports that facilitate large-scale data comparison and analysis. This tool is crucial for precision medicine and better understanding diseases in RWD studies. Smart Reporting has a strong presence in the radiology field and was highlighted in a comprehensive Imaging IT round-up. Proscia further introduced an RWD solution on its Concentriq® platform, integrating over 10 million pathology images with clinical and genomic data. This tool offers life sciences organizations access to de-identified patient data for drug development and marks a pivotal step toward making IMS platforms essential links between research and clinical applications. In hematology, Beckman Coulter Diagnostics and Scopio Labs expanded their partnership, adding the Full-Field Bone Marrow Aspirate (FF-BMA) application to their existing automated hematology solutions. This marks a successful continuation of their collaboration, which began in 2023.

Imogen Fitt from Signify Research joins us to recap the news and events of August. Paige recently announced several key changes, starting with the appointment of Razik Yousfi as the new CEO. Paige is transitioning its diagnostic AI applications to a standalone solution compatible with other digital pathology platforms. Additionally, the company partnered with Indica Labs, integrating AI models into Indica’s workflow software and focusing on joint commercial efforts in pharma services, preclinical, and translational applications. This shift away from the IMS follows challenges such as market demand for interoperability and slow clinical growth. Paige also announced that its cancer research models, Virchow and PRISM, will be open-source, while advanced versions remain commercially licensed, aiming to boost algorithm usage through its collaboration with Microsoft. Roche expands its digital pathology open environment by integrating over 20 AI algorithms from eight collaborators to enhance cancer diagnostics and precision medicine. On the funding front, PreciseDx secured $20 million in a Series B round to commercialize PreciseBreast™ risk assessment. Labcorp and Quest Diagnostics' involvement signals growing interest from major labs in digital pathology (DP). Similarly, SigTuple raised $4 million to expand geographically, focusing on its AI-powered diagnostics product AI100, which received FDA clearance and is expanding into various global markets. In partnerships, Tribun Health teamed up with Ibex Medical Analytics to integrate Ibex’s AI solutions into its CaloPix platform, offering services in the EU, US, and Canada. Tribun Health’s future AI strategy emphasizes workflow efficiency, strategic collaborations, and interoperability, positioning the company for broader platform integration. Lastly, Ibex Medical Analytics and PathAI both received IVDR certifications, marking growth milestones for their prostate, breast, and gastric AI solutions. PathAI also announced new developments regarding its IMS platform. These moves highlight a growing momentum in AI-driven diagnostics and partnerships in the healthcare sector.

The July Digital Pathology Round-up with Imogen Fitt of Signify Research is here. Nucleai and Proscia Partnership: Nucleai and Proscia have partnered to integrate Nucleai's AI Predictive Biomarker algorithms into Proscia's Concentriq platform. This collaboration aligns with the rising interest in digital companion diagnostics (CDx) in clinical trials and diagnostics. The demand for imaging biomarkers is driving rapid investments, especially from pharmaceutical companies, which will influence the digitization of clinical labs. Proscia also updated its digital pathology software, adding DICOM image support and a multi-AI overlay feature, enabling the use of multiple AI tools in the pathology workflow. UK Pathology and Genomics Collaboration: The National Pathology Imaging Co-operative (NPIC) partnered with CellPath to install two Whole Slide Imaging (WSI) scanners, connecting them to NPIC's national digital pathology system. These scanners will create a digital archive for the 100,000 Genomes Project, a precision medicine initiative. This integration aims to enhance genomics research and develop prognostic algorithms for patient stratification. Asia-Pacific Developments: 3DHISTECH announced Epredia China as its new distributor. Indica Labs announced new reseller agreements in the Asia-Pacific region, covering the Philippines, Thailand, Vietnam, and Malaysia. Indica Labs plans to pursue IVD registrations, indicating growth opportunities in the APAC region. Generative AI in Digital Pathology: Scientists from Weill Cornell Medicine and Dana-Farber Cancer Institute developed generative AI tools based on ChatGPT for digital pathology. These tools provide accurate responses to digital pathology queries and help pathologists with PathML, a library for DP image analysis. While impactful in academic circles, concerns about accountability and regulation limit their clinical application. Philips received 510(k) clearance for its IntelliSite Pathology Solution 5.1, signaling potential competitive dynamics in the US digital pathology market. Funding Announcements: Scopio Labs raised $42 million in a Series D round led by Fortissimo Capital, aiming to expand globally with a focus on the US market. Clarapath secured $36 million in a Series B-1 round to commercialize its automated microtomy system, SectionStar.

A lot to talk about in June… ZayaAI introduced a Pathology Laboratory Information System (LIS), addressing integration issues between digital pathology IMS and outdated lab software. The acquisition of Visonex by PreciPoint further indicates market convergence. PathAI launched two AI products: PathExplore™ Immuno-Oncology Profiling (IOP) and IHC Explore1™, aimed at single-cell image analysis for biomarker discovery and companion diagnostics. Roche gained FDA 510(k) clearance for its VENTANA DP 200 scanner, marking rapid growth in the US market amidst increased regulation. Tempus AI went public, providing digital pathology services and patient data access, competing with vendors like Paige and PathAI through advanced algorithms for IHC and H&E staining. Imogen Fitt is Senior Market Analyst at Signify Research. During her tenure Imogen has completed studies on digital pathology, LabIT and the use of AI in drug development, expanding Signify Research’s diagnostics and life sciences business coverage.

Moving digital pathology to the cloud. We're talking about cloud computing the features and components of the cloud and how it differs from on premise computing. What are the barriers and overlooked considerations in moving your operations to the cloud? What is the truth about storage costs in 2024? Is it still a concern or have the gains been eaten away by the increasingly large amounts of data we continue to generate? How can cloud computing unlock exciting new applications at a lower cost for organizations? And finally we discuss regulatory considerations for the cloud from the perspective of the FDA EU, GD CP and GCP in developing new drugs and diagnostics. Alan Lorimer, started his professional journey as an electronics engineer at the BBC. Over his 40-year career, he's founded or led four successful businesses. Notably, he drove an IT hosting company to a successful exit in 2011. He then specialized in IT due diligence for around 60 European companies going through some kind of transaction, sharpening his analytical prowess. In 2016, Alan pivoted to digital pathology, creating the innovative QDPconnect with OracleBio, leading to the launch of Sciento Technology. Alan's journey from the BBC to cloud computing exemplifies his relentless drive for tech innovation and industry impact.

Today we are discussing how treatment decisions can be personalized through artificial intelligence and digital pathology. Our guest is Andre Esteva of Artera. Atera’s first product is in prostate cancer. We discuss how AI can improve upon the current state of the practice which largely relies on making decisions based on clinical nomograms. We discuss the concepts prediction and prognosis and how both are incorporated into treatment decisions; what goes into developing and validating AI based algorithms in digital pathology and the importance of validating these algorithms in the appropriate studies specifically randomized clinical trials. There is one huge advantage of AI based digital pathology tools over genomics and molecular tools. Image based tools can be performed instantaneously rather than waiting days to weeks. Andre Esteva is a researcher and entrepreneur in medical artificial intelligence. He currently serves as CEO of Artera and was previously Head of Medical AI at Salesforce Research. He has worked at Google Research, Sandia National Labs, GE Healthcare, and has founded four companies. His research efforts have largely focused on medical AI diagnostics and precision medicine. His publications have made the covers of Nature and Nature Medicine, and have been featured in Cell, The Lancet, NeurIPS, and similar venues. These works have been widely covered by the WSJ, Fortune, BBC, The Economist, and hundreds of other news outlets.

What is pathology 3.0? We are at an inflection point. The demand on pathologists in laboratory medicine is greater than ever. Demographics and healthcare needs of the population are shifting. New technologies such as digital pathology and molecular diagnostics are now a reality. The rules of the game are changing. There are times in any industry where massive change is inevitable and there is great opportunity to grow. And for this, we need a new mindset. Pathology 1.0 was transactional. Clinicians would send in the specimen we would send the results. Passive and fragmented. Not responsive. Pathology 2.0 involved consolidation, taking advantage of economies of scale and scope. But still transactional and fragmented. Pathology 3.0 is connected, intelligent and evolving. Pathologists can add unique value and build on previous waves of consolidation. It transcends the boundaries of disciplines and organizational silos. It integrates new technologies and is interactive. Branko Perunovic is Chief Medical Officer at Black Country Pathology Service, where he leads the pathology consolidation and the delivery of high-quality and innovative pathology services. His journey has taken him through various aspects of healthcare, including transforming pathology services, consolidating labs, fostering collaborative team dynamics, and pioneering the integration of digital pathology and digital innovation in laboratory medicine. His ultimate goal is simple: to improve patient care, making the pathology service the provider, employer, and investment of choice. Together with a dedicated team, we can achieve this vision and create a healthcare landscape that truly puts patients first.

The May Digital Pathology Roundup with Imogen Fitt of Signify Research is here. We cover 3 main topics this month: 1. Updates and new releases in the scanner sector, Including 3DHISTECH 2. Cloud and Ai marketplace developments including Aiforia 3. The state of AI adoption and real-world implementations, with news from Ibex and Aiforia We also clarify some news from last month. PathAI in its entirety isn't being sold off to Quest. Quest will be acquiring 'select assets of PathAI Diagnostics', which will evolve into Quest's 'AI and digital R&D and solutions center'. Imogen joined Signify Research in 2018 as part of the Healthcare IT team. During her tenure Imogen has completed studies on digital pathology, LabIT and the use of AI in drug development, expanding Signify Research’s diagnostics and life sciences business coverage.

Is it time for digital biomarkers? Our guest today is Torbjørn Furuseth of DoMore Diagnostics. Predictive and prognostic algorithms may be the crown jewel of digital pathology, enhancing our value as pathologists to be the chief purveyor of this information in assisting doctors and patients. We discuss the unmet need in oncology, particularly in colon cancer, to develop predictive and prognostic tools to guide therapy. We also explore the advantages of digital pathology over molecular tools and how these methodologies can be used together in some cases. What goes into the development and validation of such tools? Why might new and innovative CPT codes be necessary to encourage innovation in digital pathology? How do reimbursement challenges affect the innovation pipeline for digital pathology? And in the increasingly global marketplace, what considerations must we take into account to help patients across the world? Torbjørn is the CEO and Co-Founder of DoMore Diagnostics, a leader in AI and deep learning precision diagnostics for digital pathology, focused on outcome prediction to personalize cancer treatment. He is a medical doctor with broad experience in life sciences and oncology. After practicing as a physician in radiology and sports medicine, he transitioned into business and management as a consultant at McKinsey & Company, where he served several pharma and healthcare clients. Following McKinsey, he has held multiple leadership positions in Norwegian life science companies and served as CFO at two immuno-oncology companies. Torbjørn’s vision is to play an important role in an important innovation.