An Innovative Approach to HER2 Classification


Paige currently holds CE-IVD and UKCA marks for HER2Complete, a clinical AI software designed to identify patients with breast cancer whose tumors have expressions of HER2 protein on H&E-stained tissue samples.* 

Trained via orthogonal proteomic and gene expression methods, HER2Complete can identify HER2 expression in patients currently classified as IHC negative (or IHC-0), in addition to expression in HER2-low (IHC1+ and 2+/FISH negative) patients. 

This approach is intended to complement existing IHC testing, potentially identifying true HER2-expressing breast cancers using only the diagnostic biopsy or resection slides. 

51% of previously diagnosed HER2-negative patients could be classified as HER2-low and eligible for new treatment options.1,2 

HER2Complete leverages cyto-architectural patterns in the tissue to identify subsets of HER2 expression within IHC 0, particularly true HER2-negative disease. 

The Power of Paige

How Paige is able to leverage data from H&E for advanced AI algorithms

Paige’s access to millions of pathology images and corresponding clinical datasets has enabled us to build best-in-class detection algorithms for uncovering cancer features from H&E-stained whole slide images alone.   

By identifying cytoarchitectural changes in tissue – across numerous tissue types – Paige is able to develop advanced AI algorithms that provide valuable insights that could empower oncologists to inform treatment decisions and clinical trial enrollment.  

Paige algorithms are developed to identify phenotypic signatures in H&E images that related to biological underpinnings,  including genotypic, prognostic and predictive features, to provide direct insight into tumor biology and enable precision oncology. 

Future HER2 Assays

Ongoing Research and Development

Paige is working to develop an HER2 assay that can help guide participant enrollment in clinical trials. Used as a screening tool, the assay would aim to identify true HER2-low candidates that could expand the cohort eligible for enrollment into future HER2 studies.  

Paige is currently conducting research into the development of an HER2 AI algorithm that would provide pathologists and oncologists insights that may inform treatment decisions . This assay would detect whether an IHC-0 or IHC-1 case expresses HER2. 

Interested in HER2 AI assays?

Stay up to date on the latest HER2 research

1 Tarantino, P. et al., (2020) J Clin Oncol. 10;38(17):1951-1962. 

2 Modi S, Jacot W, Yamashita T, et al; DESTINY-Breast04 Trial Investigators. Trastuzumab deruxtecan in previously treated HER2-low advanced breast cancer. N Engl J Med. 2022;387(1):9-20.

*In the United States, the software is available for Research Use Only and not for use in diagnostic procedures.