AI-Assisted Diagnostics

Paige’s AI-assisted diagnostic and biomarker AI applications meet the highest standards and are designed to support some of the most challenging cancer cases.

Used daily by leading pathology labs worldwide 

Paige has a strong history of regulatory achievements in AI for pathology 

Paige develops AI solutions that drive innovation and meet the highest regulatory standards. This underscores our continued leadership in building clinical applications that establish a new benchmark for regulatory excellence—advancing patient care and shaping the future of pathology.

  • First FDA-approved AI in pathology⁴ⁱⁱ

  • 3 FDA Breakthrough Designations 

  • 13 CE-IVDD Marks

  • 13 UKCA Marks 

AI-Assisted Diagnostic Applicationsⁱ

Paige has developed a wide range of AI assisted diagnostic applications, enabling increased diagnostic confidence

Paige Prostate

The Paige Prostate Suite is a group of comprehensive AI-powered applications that aid in the detection and grading of prostate cancer on H&E-stained whole-slide images of prostate needle biopsies. 

Paige Prostate Detect was the first AI-based software application in pathology to receive FDA approval to aid in the primary diagnosis of prostate cancer.ⁱⁱ

  • Assists in the detection of foci suspicious for cancer 

  • Categorizes areas suspicious for cancer by Gleason pattern, providing a primary and secondary Gleason grade prediction, as well as a percentage and linear measurement of tumor burden 

  • Aids in the detection of suspicious foci around nerve fibers, identifying the presence of PNI 

Independent validation studies have shown Paige Prostate Detect to

  • Enhance Efficiency - up to 21.9% reduction in slide evaluation times¹ 

  • Reduce Diagnostic Turnaround Times – 65.5% reduction in time to diagnosis³ 

  • Support a Confident Diagnosis – 70% reduction in diagnostic error⁴ 

  • Can reduce the need for IHC and associated cost reduction¹

Read more in our published studies

Paige Breast

The Paige Breast Suite is a set of AI-powered applications that support in the identification and classification of breast cancer on H&E-stained whole-slide images from breast biopsy and excision specimens.  

Paige Breast Lymph Node was awarded FDA Breakthrough Designation.

  • Highlights foci suspicious for cancer and pre-cancerous neoplasms 

  • Identifies individual mitotic figures, locates the mitotic hotspot, and automatically calculates mitotic counts mitotic density 

  • Detects foci that are suspicious for breast cancer metastasis from lymph node specimens 

  • AI assay that can measure HER2 expression from H&E samples, including the identification of HER-2 low patients 

Studies have shown that Paige Breast Lymph Node AI can detect metastases of any size with 98% sensitivity and shorten the reading time of lymph node slides by as much as 55%⁵

Read more in our published studies

Paige GI

The Paige GI Suite is a new and powerful portfolio of AI-powered applications designed to support pathologists in the detection and classification of benign and malignant condition across the entire gastrointestinal tract.  Built off Paige’s latest foundation model technology this represents the most powerful range of diagnostic AI applications for GI pathology. 

  • Detect, classify and localize cancer, pre-cancer and benign lesions in biopsies and resection specimens from anywhere across the GI systems including esophagus, stomach, small intestine, gall bladder, pancreas, large bowel and rectum

  • Identifies foci suspicious for colon carcinoma and high-grade dysplasia (HGD)

  • Detects the presence or absence of high microsatellite instability (MSI-H) or mismatch repair-deficient (dMMR) phenotypes from colon biopsies and resections containing cancer 

Unlike other AI solutions that focus on a single tissue type, the Paige GI Suite is a comprehensive, system-wide solution. It is designed not only to help identify disease presence but also to assess its severity, grading inflammatory conditions, dysplasia, and malignancies.

Read more in our published studies

Paige PanCancer

Paige PanCancer Detect⁺ is the first AI application of its kind designed to identify regions suspicious for cancer across multiple tissues and organs. Built to detect regions of interest that might have otherwise been missed, Paige PanCancer can empower pathologists to triage cases more efficiently. 

Paige PanCancer was awarded FDA Breakthrough Device Designation, this application has been internally validated on 21 biopsy and 25 resection tissue types, making it a uniquely flexible tool to analyze a range of diverse cases. While tested on these tissues, PanCancer’s capabilities could extend even further.

    • Parathyroid 

    • Ovary 

    • Upper GI 

    • Adrenal Gland 

    • Colon 

    • Breast 

    • Cervix 

    • Vagina 

    • Lymph Node 

    • Pancreatobiliary 

    • Liver 

    • Lung 

    • Peritoneum 

    • Soft Tissue 

    • Endometrium 

    • Prostate 

    • Bone 

    • Head and Neck 

    • Brain 

    • Bladder 

    • Skin 

    • Parathyroid 

    • Cervix 

    • Prostate 

    • Head And Neck 

    • Ovary 

    • Brain 

    • Kidney 

    • Pancreatobiliary 

    • Liver 

    • Breast 

    • Endometrium 

    • Colon 

    • Upper GI 

    • Bone 

    • Soft Tissue 

    • Peritoneum 

    • Bladder 

    • Testis 

    • Thyroid 

    • Lung 

    • Lymph Node 

    • Vagina 

    • Appendix 

    • Skin 

    • Salivary Gland 

On internal studies conducted by Paige, PanCancer Detect demonstrated a specimen-level AUC of 0.95 across both common and rare cancers—showcasing its potential to deliver meaningful support in the most complex diagnostic environments. 

Read more in our published studies

Why Pathologists Choose Paige 

Every day, pathologists leverage Paige's AI applications to enhance their diagnostic confidence, improve workflow efficiencies, and ultimately deliver better patient care. From image analysis and decision support to workflow automation, Paige’s software is being used to support hospitals and labs worldwide.

Minimize time on routine tasks 

Receive continuous quality assurance 

Flag small or hard-to-find cancers faster 

Prioritize cases with suspected malignancy  

Existing integrations with other digital pathology platforms  

Automate measurement, grading, quantification and classification  

We offer flexible deployment through a wide network of industry-leading digital pathology partners. 

Seamless Deployment. Wherever You Work.

For labs seeking a turnkey solution, Paige also offers direct access through the Paige Platform, our end-to-end digital pathology environment featuring: 

  • FullFocus® | an FDA-cleared, whole-slide image viewer 

  • FullFolio™ | an intuitive image management system designed for streamlined case organization and review 

Whether you're running a large hospital network or a specialized lab, Paige aims for rapid deployment, minimal disruption, and provides maximum value so you can get the best out of your team. Our team works closely with your team to ensure a smooth onboarding process—from integration to training and support. 

"The authorization of this AI-based software can help increase the number of identified prostate biopsy samples with cancerous tissue, which can ultimately save lives."

— Office of In Vitro Diagnostics and Radiological Health, FDA Center for Devices and Radiological Health