Genomate Health

Artificial intelligence is claimed, and the company's own description of the system is a rule set. The site sells Genomate as AI-powered and as computational intelligence, but the paper that introduced the Digital Drug Assignment system (npj Precision Oncology, 2021) describes it as a complex if-then rule-based expert system built on a curated network of more than 12,000 published driver, target and drug associations, with scoring weights set as constants, and says its algorithms were developed manually rather than learned from training data. The 2025 lung cancer paper describes the same scoring model, and the technology page describes 34,000 algorithms applied to published evidence. No component whose parameters are estimated from data is described anywhere, so no learned component can be found.

That does not make the scoring worthless; it is an open, evidence-weighting system that a clinician can inspect. It is not machine learning, which is what the AI label leads a buyer to expect.

A person stands between the ranking and the patient, and the limits of the ranking are not published. The report is for physicians and qualified professionals, the second opinion is reviewed by molecular genetics experts and a licensed oncologist who leads the consultation, and the 2021 paper says the system is built for human supervision, listing the evidence behind every score. The papers treat a score of 1,000 or more as high.

What is missing is what the ranking should not be used for: no published statement covers tumor types or alteration combinations with thin evidence, conflicting evidence, or when a clinician should set a high score aside.

The method is described in detail; the update practice is not. The 2021 paper sets out how the Digital Drug Assignment system works: a curated network of more than 12,000 driver, target and drug associations drawn from published evidence, each weighted by evidence level and by constant matching weights for how closely the evidence resembles the patient's tumor, aggregated into a score for each drug. The technology page adds that 34,000 algorithms produce a score in milliseconds. That is enough for a reader to follow the logic.

The evidence network is updated continuously (the pediatric analysis credits updates for a higher approval rate), but no version identifiers or statement of when and how the rules change is published.

A short chain: the scoring system is Genomate's own and no outside model is described. The ranking comes from the company's curated evidence network and rules, and the second opinion adds review by an independent licensed oncologist, whose practice is not named. The privacy policy says platform data stays in region-specific US and EU environments.

The cloud provider, subprocessors and the consulting provider are not named, and the platform privacy policy and data processing agreement that would list them are not published.

Published retrospective analyses, and no prospective test of the headline outcome claim. The company leads with outcome claims (longer progression-free survival, four times the response rate, 2.6 times longer survival in lung cancer). The evidence is retrospective scoring of past treatment decisions: in the SHIVA01 trial data (npj Precision Oncology, 2021), drugs with high scores were associated with disease control and longer median progression-free survival (3.95 against 1.95 months); in 111 lung cancer patients (npj Precision Oncology, 2025), high-score drugs were associated with better response, progression-free and overall survival; and a pediatric series reports matching rates. These are peer reviewed but retrospective, and the authors are mostly company staff or affiliates.

No prospective study tests whether using the ranking changes outcomes, which is what the claims require.

The patient-facing documents make some commitments; the ones governing the platform's genomic data are not published. The HIPAA notice (effective 5 February 2026) says Genomate does not use health information for marketing or sell it without written authorization.

The privacy policy (updated 20 April 2026) says US data is stored and processed in the United States and EU data in the EU, and refers the processing of genetic and medical data for oncology decision support to a separate platform privacy policy and data processing agreement, neither of which is published. Retention, de-identification and whether submitted profiles are used to develop the evidence network are therefore not stated. Nor does the company describe its safety engineering, meaning guardrails, hallucination mitigation or how a safety event is handled.

Business associate status is stated for the patient service, with the agreements unpublished. The HIPAA notice of privacy practices (effective 5 February 2026) says Genomate does not practice medicine, that the independent consulting provider is the covered entity, and that for the second opinion service Genomate acts as a business associate to that provider, using health information only to deliver the service; it sets out patients' rights and states no sale or marketing use without authorization. The privacy policy refers platform customers to a data processing agreement that is not published, so the terms for oncology practices and laboratories cannot be read.

A recognized certification is named in the company's own material, without the certificate. Genomate announced certification to ISO/IEC 27001:2022, issued by BSI in April 2025, for an information security management system covering the development, operation and maintenance of its precision oncology solutions and services. The certificate number, validity date and statement of applicability are not published, and there is no trust portal.

No device claim is made in the United States, and the product is scoped as decision support. The site footer says Genomate is clinical decision support software, not intended to diagnose, treat, cure, prevent or mitigate any condition, that its report is for physicians and qualified professionals, and that its statements have not been evaluated by FDA. The company holds ISO 13485:2016 certification from BSI (September 2025) for in vitro diagnostic software and calls it the first step toward IVDR certification in Europe and FDA clearance in the United States; no submission or designation is stated.

The outcome claims on the home page go further than the decision support framing.

The system is described as transparent and unbiased, with no evaluation behind the second word. The technology page says the algorithms are transparent, unbiased and based on sound scientific principles, and the scoring does expose the evidence behind each ranking.

But the evidence network is built from published literature and trials, which over-represent some tumor types, alterations and populations, and no published analysis compares how the scores perform across tumor types, age groups or ancestry. The pediatric and lung analyses each report results within one group without a comparison between them.

A clinician can trace each score to its evidence, and nothing stands behind the ranking. The 2021 paper states that the system lists the published evidence used in each score and generates text describing the alterations and associated drugs, so a tumor board can check why a drug ranked where it did; the second opinion service adds review by a licensed oncologist. The papers report outcomes by score group rather than an error rate for the ranking. The footer states the report is to be interpreted only by qualified professionals and is not intended to diagnose or treat, and no guarantee, indemnity or remediation attaches to a ranking.

Integration is with sequencing reports rather than the chart, and no system is named. The product reads a patient's existing NGS report, and the company describes work with sequencing laboratories to enhance their reports, including a European consortium project; the second opinion service works from records the patient submits. No EHR, laboratory information system, interface standard or named production deployment is described.

Residency is stated by region, with the host and processing path left open. The privacy policy says platform data from people in the EU is stored and processed in the EU and data from people in the United States in the United States, in region-specific environments, and that data is not routinely moved between them; any necessary transfer uses standard contractual clauses, and the company participates in the EU-US Data Privacy Framework. The service is hosted by the company; the cloud provider, tenant isolation and the systems used by the consulting oncologists are not named.

One service is priced; the clinician platform is not. The second opinion service for US patients is listed at $1,495, HSA and FSA eligible, ordered online, and includes the analysis, a review by a licensed oncologist and a telehealth consultation. No price is published for the Genomate report sold to oncologists, laboratories, payers or drug developers, which are reached through a contact form.

Coverage is named, with retrospective analyses behind part of it. The product serves oncologists choosing targeted therapy from a tumor's molecular profile across solid tumors, with a second opinion service for US patients and offerings for laboratories, payers, cancer centers and drug developers. Published analyses cover the SHIVA01 trial population (from France), lung cancer and pediatric tumors, all from European data; use in US practice is newer and unvalidated in print.