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23andMe Personal Genome Service (PGS) Genetic Health Risk Test for Hereditary Thrombophilia

23andMe, Inc.

23andMe Personal Genome Service (PGS) Genetic Health Risk Test for Hereditary Thrombophilia is cataloged as an AI-enabled laboratory medicine product associated with immunology workflows. Source records identify 23andMe, Inc. as the associated developer or manufacturer.

Designed for

Laboratory professional and clinician

Care setting

Clinical laboratory and diagnostic workflows

Specialty

Immunology

Catalog record · evidence not yet assessedCatalog updated 2026-08-31

Evidence not yet characterized

This catalog entry is based on 1 public source record. RIR has not yet characterized the product's clinical evidence.

This is a catalog and scoping record. RIR has not completed a public-evidence assessment of this product. Inclusion is not endorsement, verification, certification, or a recommendation.

What the source record supports

The linked sources support catalog inclusion and identify the product and associated organization. They do not constitute an RIR evidence assessment.

What still needs verification

Current product-family mapping, exact intended use and version, present availability, independent performance, subgroup behavior, workflow effects, safety monitoring, and patient outcomes may remain unresolved.

Working intended-use description
Support laboratory professional and clinician in clinical laboratory and diagnostic workflows within the source-described laboratory medicine workflow.
Intended-use status
Inferred from category/workflow metadata — do not publish as verified
Represented version
Public sources accessed 2026-08-31; represented software version not established
Regulatory context
FDA's AI-Enabled Medical Device List contains 1 record for this candidate (DEN160026); the latest listed decision date is 2017-04-06. Product-family mapping, current marketing status, and the exact authorized scope require decision-record review.

1 source records used to identify or scope this catalog entry.

For clinical and investment reviewEvidence context and questions for deeper review

Current source base

This catalog entry is based on 1 public source record. RIR has not yet characterized the product's clinical evidence.

Important limitation

Current product-family mapping, exact intended use and version, present availability, independent performance, subgroup behavior, workflow effects, safety monitoring, and patient outcomes may remain unresolved.

Questions to ask

  1. 01Which specimen types, instruments, populations, and reference methods were validated?
  2. 02How are low-quality, rare, discordant, and out-of-distribution results handled?
  3. 03What evidence links use to diagnostic accuracy, turnaround, and patient outcomes?