Paige Diagnostic AI Suite

The Paige Diagnostic AI Suite is a comprehensive portfolio of AI-assisted diagnostic and biomarker applications developed by Paige.ai to support pathologists in the detection, grading, and classification of cancer across a wide range of tissue types. Designed to meet the highest regulatory standards, Paige's solutions are used daily by leading pathology labs worldwide, helping clinicians enhance diagnostic confidence, reduce turnaround times, and improve patient outcomes across both routine and challenging oncology cases.

Paige holds a strong record of regulatory achievement, including being the first company to receive FDA approval for an AI application in pathology, three FDA Breakthrough Device Designations, 13 CE-IVDD Marks, and 13 UKCA Marks. These milestones reflect Paige's continued leadership in building clinically validated, regulatory-grade AI tools that set a new benchmark for the field of digital pathology.

Paige Prostate Suite

• The Paige Prostate Suite aids in the detection and grading of prostate cancer on H&E-stained whole-slide images of prostate needle biopsies.
• Paige Prostate Detect — the first FDA-approved AI application in pathology — assists in the detection of foci suspicious for cancer.
• Paige Prostate Grade & Quantify categorizes areas suspicious for cancer by Gleason pattern, providing primary and secondary Gleason grade predictions, as well as percentage and linear measurements of tumor burden.
• Paige Prostate Perineural Invasion (PNI) aids in the detection of suspicious foci around nerve fibers, identifying the presence of perineural invasion.
• Independent validation studies have shown Paige Prostate Detect delivers up to a 21.9% reduction in slide evaluation times, a 65.5% reduction in time to diagnosis, a 70% reduction in diagnostic error, and can reduce the need for immunohistochemistry (IHC) and associated costs.

Paige Breast Suite

• The Paige Breast Suite supports the identification and classification of breast cancer on H&E-stained whole-slide images from breast biopsy and excision specimens.
• Paige Breast Detect & Neoplasm highlights foci suspicious for cancer and pre-cancerous neoplasms.
• Paige Breast Mitosis identifies individual mitotic figures, locates the mitotic hotspot, and automatically calculates mitotic counts and mitotic density.
• Paige Breast Lymph Node — awarded FDA Breakthrough Device Designation — detects foci suspicious for breast cancer metastasis from lymph node specimens, with studies showing 98% sensitivity for metastases of any size and up to a 55% reduction in lymph node slide reading time.
• HER2Complete is an AI assay that measures HER2 expression from H&E samples, including identification of HER2-low patients.

Paige GI Suite

• The Paige GI Suite is a portfolio of AI-powered applications built on Paige's latest foundation model technology, designed to support pathologists across the entire gastrointestinal tract.
• Paige GI Detect & Subtype detects, classifies, and localizes cancer, pre-cancer, and benign lesions in biopsies and resection specimens from the esophagus, stomach, small intestine, gallbladder, pancreas, large bowel, and rectum.
• Paige Colon Detect identifies foci suspicious for colon carcinoma and high-grade dysplasia (HGD).
• Paige Colon MSI 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 single-tissue AI solutions, the Paige GI Suite is a comprehensive, system-wide solution that assesses disease presence and severity, including grading of inflammatory conditions, dysplasia, and malignancies.

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, enabling pathologists to triage cases more efficiently.
• Awarded FDA Breakthrough Device Designation, PanCancer has been internally validated on 21 biopsy tissue types — including prostate, breast, lung, liver, colon, brain, bladder, skin, lymph node, and more — and 25 resection tissue types.
• Internal studies demonstrated a specimen-level AUC of 0.95 across both common and rare cancers, highlighting its potential in complex diagnostic environments.
• PanCancer is designed to detect regions of interest that might otherwise be missed, making it a uniquely flexible tool for diverse and challenging cases.

Key Workflow and Diagnostic Benefits

• Minimizes time spent on routine tasks, freeing pathologists for higher-complexity work.
• Provides continuous quality assurance across case reviews.
• Flags small or hard-to-find cancers faster, reducing the risk of missed diagnoses.
• Prioritizes cases with suspected malignancy to support efficient case management.
• Automates measurement, grading, quantification, and classification tasks.
• Integrates with existing digital pathology platforms through a wide network of industry-leading partners and collaborators.

Deployment and Platform

• Paige offers flexible deployment through a broad network of digital pathology partners, enabling integration into existing lab environments with minimal disruption.
• For labs seeking a turnkey solution, the Paige Platform provides an end-to-end digital pathology environment including FullFocus®, an FDA-cleared whole-slide image viewer, and FullFolio™, an intuitive image management system for streamlined case organization and review.
• Paige's onboarding process includes close collaboration with lab teams, covering integration, training, and ongoing support to ensure rapid deployment and maximum value for hospitals and specialized labs alike.