DoMore Diagnostics

A single deep learning model is the entire company. Histotype Px Colorectal reads standard H and E stained slides and returns a risk group; there is no assay, sequencing step, viewer, or laboratory of its own. The company's positioning makes the centrality explicit: the entire value proposition is extracting prognostic signal from slides already produced, in a field where the alternative biomarkers require gene sequencing that decades of investment have failed to deliver adequately for this indication.

Produces a low, intermediate, or high risk stratification that informs an oncologist's adjuvant chemotherapy decision, so the human retains the treatment call. The three tier output rather than a binary flag is a meaningful design choice, since it surfaces genuine uncertainty in the middle group rather than forcing every patient to one side of a threshold. The consequential direction here is de-escalation, identifying patients who may safely avoid chemotherapy, which means a false low risk classification carries a different and more serious cost than a false high risk one, and the vendor materials do not quantify that asymmetry.

Training scale is disclosed specifically at close to 100 million image tiles, the provenance is named as research led by the Institute for Cancer Genetics and Informatics at Oslo University Hospital, and the company is careful to distinguish the commercial product from its research predecessor, noting that the early version was called DoMore-V1-CRC during development and that the CE-IVD certified product is an updated version. Naming that distinction rather than claiming the research paper validated the shipping product is a real transparency point. Model architecture and per subgroup performance are not published.

The strongest evidence base of any pathology vendor added in this sweep. An early version of the algorithm was published in The Lancet, and a landmark study in The Lancet Oncology by Kleppe and colleagues demonstrated that the marker significantly improves prognostic accuracy when combined with TNM staging, validated within the QUASAR II trial with a reported hazard ratio of 9.47 comparing high versus low risk groups. Validation inside a randomised controlled trial cohort is a materially higher standard than a retrospective institutional series, because trial cohorts have adjudicated outcomes and controlled treatment. Independent survey work on public evidence for digital pathology AI products lists this among the products where publication preceded regulatory approval, which is the right order.

No specific PHI handling or data governance framework was located in the materials reviewed.

No HIPAA or BAA commitment was located. The product is CE-IVD marked for European clinical use rather than FDA cleared, so US deployment is not the current route.

No SOC 2, ISO 27001, or equivalent attestation and no trust center were located in the materials reviewed.

CE-IVD marked and reported as the first CE marked product using AI to predict patient outcome from image analysis, which is a category first rather than a routine certification. No FDA clearance was located. One detail a buyer should note: the company's own product page states the mark is CE-IVDD, the older directive, rather than IVDR, the same distinction flagged against Visiopharm's DeepBio prostate APP and Owkin Dx, and IVDD carries a lower evidence bar than IVDR. Graded C on the established basis of real European authorization without US clearance, with the caveat that the underlying clinical evidence here is unusually strong for a C on this axis.

Validation within a randomised trial cohort provides controlled conditions and adjudicated outcomes, and publication preceding regulatory approval indicates evidence was generated before commercial claims. No formal governance framework, monitoring commitment, or demographic subgroup analysis was located. The gap matters for a de-escalation tool, since a risk model that systematically underestimates in any patient group would direct those patients away from chemotherapy they would have benefited from.

Designed to sit inside existing hospital pathology workflow rather than requiring a dedicated environment, with the company stating the product adds value across the various digital pathology platforms available rather than tying to one. Third party product profiling describes integrations or partnerships with digital pathology platforms including PathAI, Sectra, Proscia, and Paige, three of which are separately indexed here. That multi-platform posture mirrors Primaa and Mindpeak and is the pragmatic route for an algorithm-only vendor. No published connector list or scanner compatibility matrix was located.

No hosting, tenancy, or data residency terms were located. Where the algorithm runs through a partner digital pathology platform, residency would follow that platform rather than this vendor.

No rates are published, but the economic argument is quantified more precisely than almost any vendor in this index, and in the buyer's own terms. The company states that most patients in this indication are cured by surgery alone and that adjuvant chemotherapy provides no benefit to 96 to 98 percent of stage II and 80 percent of stage III patients, meaning the value case is avoided chemotherapy cycles and avoided toxicity, both of which a payer or health system can cost directly. Turnaround is also framed against the comparator, delivering risk information immediately after surgery rather than the weeks to months current markers require. Third party listings describe enterprise diagnostic, oncology, and platform-partner pricing available on request.

A single indication precisely specified: outcome prediction in stage II and III colorectal adenocarcinoma to inform adjuvant chemotherapy decisions following surgical resection. That focus is the source of its evidence depth, since the QUASAR II validation is specific to exactly this decision. It does not extend to other tumour types, to metastatic disease, or to diagnostic as opposed to prognostic tasks, and the Histotype Px naming suggests intended expansion to further indications not yet certified.