Since inception, Paige has been a leader in cancer diagnostics and AI innovation, developing industry-leading products, forging robust strategic partnerships, and bringing unparalleled efficiency and confidence to pathologists across the globe.
2022 proved to be an exciting year as we continued to expand our product offerings, conduct pioneering research, and lay the groundwork for further industry change. “Everything we do here at Paige is intended to positively impact patient lives,” said Andy Moye, CEO. “We are proud of all the work we have accomplished to meet that goal throughout 2022 and are looking forward to further empowering pathologists and oncologists in 2023.”
Product Launches and Regulatory Achievements
In March 2022, we officially released Paige Breast Lymph Node, our AI to aid pathologists in the detection of metastases in breast cancer lymph node slides, guiding pathologists to areas suspicious for metastases including ITCs and small challenging micromets to improve diagnostic confidence. We have since published an exciting case study that found that Paige Breast Lymph Node helped reduce pathologists’ total read times by over 55%.1
We also released our Paige Prostate Biomarker Panel, which was granted CE-IVD and UKCA marks in May 2022. This marked the first European regulatory clearance for Paige’s digital biomarker capabilities, signalling a shift toward the next generation of biomarker testing; one that Paige is excited to lead.
Following on from this biomarker release, we launched HER2Complete™, the first and only H&E based digital biomarker capable of detecting morphological phenotypes consistent with HER2 expression in IHC negative or equivocal-IHC1+ samples, in June 2022. The assay received CE-IVD and UKCA marks and has the potential to improve current understanding of HER2-negative breast cancer cases in ways not possible using current diagnostic methods.
With these clearances, Paige now holds 13 total CE-IVD and UKCA marks for FullFocus® and 18 distinct AI products, as well as 2 FDA authorizations for our Paige Prostate Detect and FullFocus products. Paige also expanded our existing Medical Device Single Audit Program (MDSAP) certification to Canada, enabling the pathway for Health Canada licenses to expand its regulatory clearance portfolio. We are currently in the final stages of our European Union In Vitro Diagnostics Regulation (IVDR) transition project, which came into effect in May 2022.
Additionally, we were proud to roll out a number of critical updates to our existing platform and products that will further enhance pathologist efficiency and diagnostic confidence. These include:
- Deeper AI integration further upstream in the digital workflow to support case prioritization
- TC/PC workflow enablement for distributed labs
- Collaboration features to enable fast and simple slide sharing
- Continued improvements to the Paige Prostate Suite, including features for better detection of Prostate PNI and improved detection for high grade cancers
- New tools to support quantification and annotation tasks
- Release of the beta version of our colon cancer detection module
- Expanded support of scanner and LIS vendors
- Rollout of UnifAI, Paige’s unique integration and deployment platform, to support AI onboarding
We are looking forward to further expanding our diagnostic AI and biomarker AI offerings in 2023.
Paige was thrilled to announce the August 2022 launch of our FullFocus viewer, Paige Prostate Detect, and Paige Breast applications at Sonora Quest Laboratories, the local market leader in clinical diagnostics in the state of Arizona.
Paige further launched several studies and trials to evaluate the impact of pathology AI in real-world clinical settings at labs across the world, including Scotland’s Industrial Centre for Artificial Intelligence Research in Digital Diagnostics (iCAIRD), Guy’s and St Thomas’ NHS Foundation Trust and King’s College London in the UK, Institute of Molecular Pathology and Immunology of the University of Porto (IPATIMUP) in Portugal, and University Medical Center (UMC) Utrecht in the Netherlands.
We’re proud to have brought in fantastic new leadership with commercial and medical expertise to keep Paige at the forefront of innovation. These include:
- Shivang Doshi, named Vice President of Global Payor Relations in April 2022
- Joe Oakley, MD, named Medical Director Of Biomarker Development in May 2022
Paige also welcomed multiple new members to our Scientific Advisory Board in April 2022, including:
- Eslie Dennis, MBChB, FCP (SA), Senior Vice President and Chief Medical Officer at Kyowa Kirin
- Chris Kanan, Ph.D., Associate Professor in the Carlson Center for Imaging Science at the Rochester Institute of Technology
- Mike Kramer, M.D., former Vice President of Pathology and Medical Services at Quest Diagnostics
- Paul van Diest, M.D., Ph.D., Professor and the Head of Pathology at the University Medical Center Utrecht, Netherlands
- Bethany Williams, MBBS, Lead for Education and Training at the National Pathology Imaging Co-operative, Leeds, UK
- Finally, Paige was honored to add two new members to our Board of Directors:
- Natan Reining, Board Member, Paige Vice President, Growth Equity, Goldman Sachs Asset Management
- Hedvig Hricak, MD, PhD, Board Member, Paige, Chair, Department of Radiology, Memorial Sloan Kettering Cancer Center
Strategic partnerships are critical to expanding pathologists’ access to cutting-edge digital pathology and AI technologies that will transform their day-to-day workflows and have positive impacts on patient outcomes.
In 2022, Paige forged alliances with OptraScan to streamline the adoption of digital pathology in health systems in the United States, European Union countries and United Kingdom, as well as with Ultivue to collaborate on the co-development and co-marketing of AI-powered spatial immunophenotype capabilities to pharmaceutical and research customers.
We additionally partnered with Flagship Biosciences and Mindpeak to provide Paige customers with access to an expanded suite of AI applications that can further support diagnostic decision-making and enhance efficiency.
Finally, Paige joined forces with Janssen Research & Development, LLC (Janssen) to deploy an AI-powered, H&E-based biomarker test developed by Janssen to screen for actionable FGFR2 and FGFR3 genomic alterations using the Paige Platform. The technology is being evaluated in Janssen’s clinical trials, with the goal of improving rates of confirmatory molecular testing and accelerating recruitment of patients into biomarker-driven clinical trials that are enrolling patients with certain tumor FGFR mutations.
Thought Leadership Highlights
Paige presented groundbreaking new research in posters this year, including:
We also had the incredible opportunity to present findings from clinical implementations of our Prostate and Breast Suites as well as insights into trends in digital pathology and AI, future predictions, and ongoing research and development at over 20 events and webinars throughout the year.
As we head into 2023, Paige remains steadfast in our mission to improve the lives of cancer patients by driving a new era of diagnostics and precision treatment. Leveraging our access to millions of pathology images and corresponding clinical datasets, Paige will continue to create best-in-class AI algorithms for diagnosing cancers across tissue types and uncovering novel insights from H&E-stained whole-slide images. Our open platform as well as deep partnerships with industry-leading scanner vendors, healthcare systems, and pharmaceutical companies position us to transform pathology and make precision medicine a reality today, and we look forward to further tapping into this potential to change the landscape of cancer care in 2023.
1Based on an investigational clinical study conducted by Paige involving 3 pathologists and data from 148 patients.