Methodology

Varia is post-test interpretation software that reads genotype calls from a DNA file you already have from another testing system (a consumer chip export, a clinical lab, or whole-genome sequencing). Varia does not perform genotyping, sequencing, or any in vitro molecular detection. Varia reports population-level associations from published science, not per-user risk scores, percentiles, disease diagnoses, or screening directives.

You load a DNA file from your device and Varia returns curated findings drawn from peer-reviewed scientific literature and named institutional authorities. The product runs entirely in your browser. Your DNA file is never uploaded.

Varia is not a Genetic Health Risk Assessment System under 21 CFR 866.5950 because Varia performs no variant detection and emits no per-user risk output. Where relevant, FDA General Wellness guidance (January 6, 2026 reissue), the Cures Act software provision for displaying medical information (21 USC 360j(o)), and general-wellness device policy (21 CFR 880.6315) may offer additional context, but those frameworks have limits: General Wellness does not cleanly cover disease-risk surfaces, the CDS non-device line applies to health care professional-facing tools with independent review, and Varia is consumer-facing post-test interpretation software.

Three editorial commitments shape every finding Varia displays:

Curated. Varia's current archive represents 64 carefully chosen variants across 6 health areas. By contrast, Promethease ships 111,702+ entries unfiltered and 23andMe reports against an opaque internal catalog. Varia picks the smaller set deliberately, because each variant that we report on has been through a seven-pass editorial review and survives a documented evidence threshold.

Transparently sourced. Every finding cites its primary literature. Every authority Varia consults appears on the Institutional Authority References page with the date Varia last reviewed it. Every detector that watches for upstream changes (ClinVar, ClinPGx, ClinGen, PharmGKB, PharmVar, Retraction Watch, ACMG SF) runs on a documented schedule with results committed to the editorial event log in our public repository.

Editorially disciplined. Varia distinguishes findings that come with clinical authority (ACMG/AMP classifications, CPIC pharmacogenomic guidelines) from findings that come from Varia's own editorial assessment (common variants and lifestyle traits where no clinical authority exists). The framework is explicit. The reasoning is visible. The cadence at which findings get reviewed is public.

Varia is not a substitute for clinical genetic testing or genetic counseling. The recommendation boundary is bright: Varia surfaces variant names and biomarker or drug class names. It does not recommend doses, supplements, products, or protocols.

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 Genetic Health Risk Assessment System under FDA rules because it performs no variant detection and no per-user risk output. FDA General Wellness guidance (reissued January 2026), the Cures Act exclusion for software that displays medical information (21 USC 360j(o)), and general-wellness device policy (21 CFR 880.6315) may add context in some cases, but Varia's primary posture is post-test interpretation of genotype calls you already hold.

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 shows you links back to the scientific papers it draws from. 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 tracks 64 variants across 6 health areas: Heart & Lipids, Brain & Cognition, Metabolism & Longevity, Medication Response, Cancer Risk, and Autoimmune. Each area groups related variants with sub-topics such as blood sugar metabolism, Alzheimer's clearance pathways, and pharmacogenomic drug response.

The catalog scope is intentional. Over the last two decades, genomic interpretation has been a bottleneck. Sequencing throughput scaled roughly six orders of magnitude in the same period, but the functional and clinical interpretation of variants grows linearly through peer-reviewed publication. Most of the human genome remains uninterpreted at the clinical-actionability level. A consumer-genomics product that surfaces every variant present in your file either oversells the actionability of those findings or hides the most defensible findings inside an unmanageable list.

Varia chooses the smaller, defensible list. Every variant in the catalog passes one of two qualification paths:

• Authority-backed: the variant has an ACMG/AMP classification in ClinVar (Pathogenic, Likely Pathogenic, or VUS) with documented review status, OR a CPIC pharmacogenomic guideline at evidence level A or B, OR a PharmGKB clinical annotation at level 1A or 1B. For these variants, Varia surfaces the institutional grade verbatim and adds a confidence chip indicating ClinVar review status.
• Varia-graded: the variant is a common-trait risk modifier (lipid metabolism, methylation pathway efficiency, inflammation response) or lifestyle association. No clinical authority grades these. Varia applies its own evidence assessment and labels the grade transparently with citations behind it.

HLA loci (HLA-B*15:02, HLA-B*57:01, HLA-DQ2 / HLA-DQ8 and similar) are deferred from the V1 catalog. Consumer chip imputation is unreliable for HLA, and whole-genome calling requires specialized pipelines beyond Varia's current scanner. When HLA returns, it returns with whole-genome-only restriction.

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.