Your AI digital pathology partner, from signal to registered assay
From biomarker discovery to an approved companion diagnostic, built on routine H&E and IHC slides.
One assay, carried from your locked trial assay through validation, registration and PMA / CE marking into labs worldwide.
ExploreFind the signal in the tissue
D biomarks hidden in H&E and IHC slides.
Map the tumor microenvironment
Our H&E and IHC platforms quantify what’s in the tissue at scale: cell types, their spatial organization, immune structures such as tumor-infiltrating lymphocytes and tertiary lymphoid structures, and target expression down to the subcellular level. Each slide becomes a set of measurable features you can analyze across your whole cohort.
Find what predicts response
We search your trial and cohort data for the tissue features linked to treatment response and outcomes. The signals that hold up are defined as measurable biomarker candidates, ready for development.
From candidate to validated biomarker
Refine, calibrate and lock your biomarker.
Models built for your biomarker
We fine-tune our pre-trained pipelines for your specific biomarker and indication, using transfer learning to reach robust performance even with limited data.
The right cutoff, tailored to your clinical question
Cutoffs are set against clinical outcomes to identify the patients most likely to benefit from your drug. Each threshold is tested for robustness, so the biomarker performs reliably beyond the data it was built on.
Locked and ready for trials
We define the biomarker’s target profile and lock the full analysis workflow. The result is a fixed, documented assay that can move into clinical trials without further changes.
From locked assay to approved companion diagnostic
One assay, carried from your trial through approval and into labs worldwide.
Built once, ready for every lab
The assay locked for patient selection in your trial becomes your approved companion diagnostic, without specific redevelopment between stages.
We design and run analytical and clinical validation studies across multiple centers in both the US and in Europe, including concordance across scanners to ensure labs reach consistent results for the same patient, whichever site tests them.
Regulatory strategy is defined at the start. Our dedicated quality and regulatory team, with experience in both the US and in Europe, plans the pathway for FDA authorization, and CE marking.
Into labs worldwide
Our platform-agnostic software works with leading image management systems, and our network of diagnostic distribution partners brings your CDx to labs across markets.
We support reimbursement and inclusion in clinical guidelines, and manage the algorithm throughout its lifecycle, so the CDx keeps reaching the patients who need it.