Genomics

The model is the product. What Health Insights sells is a risk estimate: polygenic risk scores, models fitted to large genotyped populations that combine information from millions of places in the genome, integrated with established clinical risk factors to estimate a person's risk of cardiovascular disease, type 2 diabetes, breast cancer and prostate cancer. The saliva kit and genotyping are the input; without the fitted scores there is no result to report. Mystra, sold to drug discovery teams, is likewise an analysis platform built on genetic data.

Ask which clinical model each integrated score builds on for US patients, since QRISK is a UK calculator.

Scores go to healthcare professionals, and the controls around them are not described. Genomics positions Health Insights as a tool for clinicians to make prevention and screening decisions, delivered in the UK through private providers and in the US through doctors, so a clinician stands between the score and any action.

Nothing published says how scores are presented against treatment thresholds, when a score is withheld for people outside validated ancestries, or how a revised model changes results already issued.

Ask how a clinician sees the genetic and clinical parts of each score and what guidance comes with a high result.

The approach is named, without version and update discipline. Genomics describes integrated risk tools that combine polygenic risk scores with established clinical models, naming QRISK for cardiovascular risk in the UK, and says its scores combine information from millions of places in the genome. No model version, training cohort description or update practice is set out on its pages.

Ask which genome wide scores and clinical calculators each Health Insights result uses in each market, the score versions, and how customers are told when they change.

The model chain is in house, and service providers are named for the corporate estate. Genomics builds its own polygenic and integrated risk models, with no outside model provider. Its privacy policy names Mythic Beasts as primary hosting, with HubSpot, Ashby, Cloudflare and Google Analytics for communications, recruitment and the website.

No processor list is published for Health Insights, including the genotyping laboratory and any US hosting, and the terms governing customer genotypes sit in notices that render only in a browser.

Ask for the processors that handle Health Insights samples, genotypes and results in each market, and their retention terms.

A named NHS study with dated figures, reported by the company. Genomics reports that in the HEART study in NHS primary care, integrating genetics with the QRISK cardiovascular calculator produced clinically significant changes in risk for 24 percent of participants, and that 13 percent would have received different clinical management. It also says its risk scores have been adopted by UK Biobank and Our Future Health, and that Health Insights is in use through Bupa, Spire Healthcare and Well Life Clinics.

The figures describe changes in risk category and intended management rather than events prevented, and the study's publication and method are not set out on the pages describing it. No outcome results for US patients are published.

Ask for the HEART study publication, its sites and numbers, and any evidence that reclassified patients were treated differently and fared better.

Retention and research use are stated for the corporate services, and the product's terms are not readable. Genomics' privacy policy keeps research data indefinitely, keeps online service data up to six years, uses de identified individual level data for research on human biology and drug discovery, notes that re identification from aggregate data is theoretically possible, and says no decisions are taken about people by automated means. Whether Health Insights customers' genotypes enter research or model development is governed by notices that render only in a browser.

Safety engineering for the risk scores, meaning how a faulty score would be detected and handled, is not published.

Ask whether Health Insights genotypes are used for research, Mystra or model development, and how long they are kept.

A UK regime is documented for the corporate services and the product carries its own notices. Genomics Ltd's privacy policy, updated 1 October 2025, names the company as data controller under UK data protection law, sets retention periods and transfer safeguards, and says that services with their own privacy notice, such as Health Insights, are governed by those. The Health Insights site renders only in a browser and its notices are not published as readable pages, and nothing readable states a HIPAA role for Health Insights USA, which is sold through US doctors.

Ask for the Health Insights USA privacy notice, Genomics' HIPAA role for US patients, and the business associate agreement offered to health systems.

A recognized certification is named without the artifact. Genomics displays BSI certification to ISO/IEC 27001 for information security management, alongside ISO 13485 for medical device quality. The certificate, its scope and its date are not published, so a buyer cannot tell whether it covers Health Insights USA's systems as well as the UK operation.

Ask for the ISO/IEC 27001 certificate with its scope statement and expiry, and whether US operations sit inside it.

A non US regime is named precisely, and the US position is not stated. Genomics says Health Insights is UKCA marked and registered with the MHRA, and describes it as the first product of its kind combining genetic and clinical factors for disease prediction under that framework. That is a stated regulatory position for the UK product.

Health Insights USA is offered through US doctors, and no FDA status, laboratory developed test position or CLIA laboratory is named for it on Genomics' pages. A buyer in the United States should match the regime to the product actually ordered.

Ask for the device class under the UKCA marking, and the regulatory basis on which Health Insights USA is offered.

A quality system is certified and no evaluation of model behavior by group is published on Genomics' pages. Genomics holds ISO 13485 for medical device quality management, which governs how the product is built and changed, and says its scores were adopted by UK Biobank and Our Future Health. Polygenic scores built largely on European ancestry data usually perform worse in other ancestries, and no results by ancestry, sex or age are set out for Health Insights.

Ask for Health Insights performance by ancestry group, especially for US patients, and how Genomics decides whether to report a score for someone outside its validated groups.

A clinician reviews the score before acting, and nothing published stands behind it. Health Insights results go to healthcare professionals who decide on prevention and screening, which lets an implausible result be questioned. Genomics' corporate privacy policy sets out data protection rights under UK law for the services it covers, but the product's own notices render only in a browser and no correction route for a Health Insights result is described.

No error rate at the thresholds that change care, warranty or remediation commitment is published.

Ask how many people the integrated score places in the wrong risk band, and what Genomics does when a reported score is revised.

No integration evidence is published. Health Insights results go to healthcare professionals through providers and doctors, and the HEART study ran in NHS primary care, but no record system, standard, marketplace listing or integrated site is described on Genomics' pages for either market.

Ask how results reach the patient's record in your system and whether the integrated score arrives as discrete data.

Location is implied rather than committed. Genomics' privacy policy says its cloud infrastructure runs in data centers primarily in the UK and in other potential locations around the world, names Mythic Beasts as primary hosting, and says data may be transferred to countries such as the USA under standard contractual clauses or adequacy decisions. That policy covers the corporate services and Mystra; where Health Insights USA processes and stores US patients' genotypes is not stated.

Ask where Health Insights genotypes and results rest for US and UK patients, and whether US data leaves the United States.

No price is published and how the product is sold can be established. Health Insights reaches UK patients through private providers such as Bupa, Spire Healthcare and Well Life Clinics, and US patients through doctors in health systems, and Genomics sells risk tools to insurers and employers and Mystra to drug discovery teams. No test price, per member fee or platform license is set out on Genomics' pages.

Ask for the Health Insights price per test in each market, how insurers and employers are charged, and whether a health system pays per patient or by program.

Coverage is named with validation behind part of it. Health Insights covers cardiovascular disease, type 2 diabetes, breast cancer and prostate cancer for adults in prevention and screening, delivered in the UK through private providers and in the US through doctors in health systems. The cardiovascular score has NHS primary care study results behind it; the published evidence for the other conditions and for US populations is not set out on Genomics' pages.

Ask which conditions carry published validation in the population you serve, and how the scores perform in ancestries under represented in UK Biobank.