Methodology

Varia is post-test interpretation software. It reads a DNA file you already have from another testing system (a consumer chip export, a clinical lab, or whole-genome sequencing). Varia does not run a new genetic test, does not perform sequencing in a lab, and does not give you a personal risk score or screening recommendation.

You open your DNA file from your device, and Varia analyzes it directly in your web browser. Your file never leaves your device.

Varia is not a medical device. It is not intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease (Federal Food, Drug, and Cosmetic Act section 201(h)). It is educational post-test interpretation of genotype calls you already hold, and it emits no personal diagnostic output, risk score, percentile, or tier. You review the cited population-level literature yourself. That, together with the fact that Varia performs no variant detection, is the load-bearing basis.

Varia is not a Genetic Health Risk Assessment System under 21 CFR 866.5950. That category covers laboratory systems used for detecting variants in DNA taken from human specimens. Varia performs no detection. The same rule also places pharmacogenomic assessment and deterministic autosomal-dominant assessment outside that class. Varia's catalog already spans those areas, which confirms the class does not apply.

Two other frameworks are supporting context only, not the basis. 21 USC 360j(o) (Cures Act software exclusions) does not cleanly cover a consumer-facing surface that references disease: the healthy-lifestyle exclusion requires the software to be unrelated to diagnosis, cure, mitigation, prevention, or treatment of a disease, and the clinical decision support exclusion is for software intended for health care professionals who independently review the basis. FDA General Wellness guidance (reissued January 2026) and 21 CFR 880.6315 exclude products that make disease diagnosis, cure, mitigation, prevention, or treatment claims, so they do not themselves license a disease-referencing finding. FTC Act section 5 still applies: public claims must be truthful and substantiated.

Three editorial commitments shape every finding Varia displays:

Curated. Varia reports on 64 variants chosen with care, organized across 6 health areas. Other consumer-genomics products either show you every variant they find without filtering (Promethease shows over 111,000), or report on a much larger set without telling you why they picked those (23andMe). Varia keeps the list intentionally short because every variant has been reviewed through a seven-step quality process before earning a spot in the catalog.

Transparently sourced. Every finding Varia characterizes links back to the scientific papers it draws from. Where Varia has no source it can verify, the finding is held as uncharacterized and says so, rather than showing you a claim with nothing behind it. The major medical authorities Varia consults (the same authorities your clinician uses) are listed openly with the date each was last reviewed. Computer programs check those authorities for updates on a published schedule, and every change gets logged in a public record so anyone can see what changed and when.

Editorially disciplined. When a clinical authority has already graded a variant (like for rare-disease risks or medication response), Varia shows you their grade directly. For variants where no clinical authority weighs in (common health-trait variants, lifestyle traits), Varia applies its own grading and shows the reasoning behind it. Either way, you see how the grade was reached and when it was last reviewed.

Varia is not a substitute for clinical genetic testing or working with a genetic counselor. The line Varia holds is clear: Varia tells you what variants you have and what published science says about them. Varia does not recommend specific doses of medication, supplements you should take, or lifestyle protocols you should follow.

Varia is built by one person, Eric Gebauer, who is not a clinical geneticist or genetic counselor. Varia is not a substitute for a consultation with one. The editorial process relies on institutional authorities (ClinGen, CPIC, ClinVar, ACMG, PharmGKB, PharmVar) and a documented change-detection schedule, not on individual clinical judgment.

Varia tracks 64 variants across 6 health areas: Heart & Lipids; Brain & Cognition, which includes APOE Alzheimer's risk and the chromosome 19 region surrounding APOE; Metabolism & Longevity, which folds in blood sugar, methylation and detoxification, longevity and aging biology, and inflammation; Medication Response, how your body processes medications; Cancer Risk, common low-penetrance cancer associations from published genome-wide studies; and Autoimmune, common autoimmune associations with explicit limits on what consumer files can assess (including HLA).

The catalog size is intentional. Over the last two decades, our ability to sequence DNA has grown roughly a million-fold, but our scientific understanding of what each variant actually does has only grown step by step through peer-reviewed publication. Most of the human genome remains scientifically uninterpreted at a level that supports actionable medical decisions. A consumer-genomics product that shows you every variant in your file is either overselling what those findings can tell you, or burying the strongly-supported findings inside an unmanageably long list.

Varia chooses the smaller, defensible list. Every variant in the catalog earns its spot through one of two paths:

• Authority-backed: a recognized medical authority has already published a grade for this variant. ACMG and ClinVar grade rare-disease risk variants. CPIC and PharmGKB grade medication response variants. When that authoritative grade exists, Varia shows it to you directly with a chip indicating how strong the consensus is.
• Varia-graded: the variant is a common health-trait or lifestyle variant. No clinical authority grades these kinds of variants. Varia applies its own evidence assessment and shows the reasoning publicly.

HLA loci (a family of immune-system variants linked to drug allergies and some autoimmune conditions) are not in the V1 catalog. Consumer DNA chips can't reliably read these regions, and reading them from whole-genome sequencing requires specialized analysis software Varia doesn't yet run. When HLA returns, it will be available only for whole-genome sequencing files.