ABAB Pedia

23andMe

23andMe is a consumer genetics and research brand offering ancestry and health-risk services. It is now operated by 23andMe Research Institute, a nonprofit based in Palo Alto, California.

Contents20 sections
Key facts

Founding and Early Service

Anne Wojcicki, Linda Avey and Paul Cusenza founded 23andMe in 2006, initially working in Palo Alto, California. Its name refers to the 23 chromosome pairs humans typically have. The consumer genetics service launched in 2007, connecting saliva-based analysis with personal exploration.⁠[1]

Regulatory Changes to Health Reports

After an FDA warning in 2013, 23andMe stopped marketing health reports in the United States while retaining ancestry and raw-data services. A Bloom syndrome carrier-test authorization followed in 2015, alongside a partial return of health services. In 2017, authorization extended to genetic health-risk reports including Parkinson’s disease.⁠[2]

Selected BRCA Variants Authorized

On March 6, the FDA authorized direct-to-consumer reporting of three BRCA1/BRCA2 variants. That version covered only the selected variants and could not exclude other inherited cancer risks. Treatment decisions required confirmatory testing and genetic counseling.⁠[3]

Drug-Discovery Partnership with GSK

On July 25, GSK and 23andMe announced a four-year drug-discovery partnership, with an option for a fifth year. GSK also made a $300 million equity investment. Research relied on voluntarily consented participant data; the investment was not a purchase price for every customer’s DNA.⁠[4]

Pharmacogenetic Reports

On October 31, the FDA authorized pharmacogenetic reports covering 33 variants associated with medication metabolism. The authorization did not establish that the report could determine whether a particular medicine suited an individual, or support changing or stopping medication without clinical assessment.⁠[5]

Public-Market Merger Completed

On June 16, 23andMe completed its business combination with special-purpose acquisition company VG Acquisition Corp. The listed parent became 23andMe Holding Co., with 23andMe, Inc. as its wholly owned subsidiary. The brand, operating subsidiary and holding company occupied different legal levels.⁠[6]

Account Intrusion and Relative-Data Exposure

The company disclosed a cyber incident in October 2023. It said attackers used reused credentials from other compromised sites to enter some accounts, then accessed additional relative information through DNA Relatives. The share of accounts directly entered therefore differed from the wider population whose information was exposed.⁠[7]

Therapeutics Restructuring

On November 11, 23andMe announced more than 200 job cuts, approximately 40% of its workforce, and discontinued internal therapeutics development. It planned to wind down associated trials and explore asset sales or licensing. The projected $35 million in annual savings was a target, not savings already achieved.⁠[8]

Chapter 11 Filing

On March 23, 23andMe entered Chapter 11 proceedings in the Eastern District of Missouri to pursue a court-supervised asset sale while continuing operations. Anne Wojcicki resigned as CEO but remained a director; Joe Selsavage became interim CEO.⁠[9]

UK Data-Protection Fine

The UK Information Commissioner’s Office fined 23andMe £2.31 million over the 2023 breach, which affected 155,592 UK residents. It identified failures in multifactor authentication, additional checks for sensitive data and threat response. The regulator also said remedial measures had addressed the identified problems by late 2024.⁠[10]

Asset Sale Approved

The court approved a $305 million sale of substantially all assets to TTAM Research Institute, encompassing Personal Genome Service, Research Services and Lemonaid Health. TTAM was a California nonprofit public-benefit corporation led by Anne Wojcicki. Closing remained conditional at the time of approval.⁠[11]

Nonprofit Acquisition Completed

On July 14, TTAM announced completion of its acquisition of 23andMe’s Personal Genome Service and Research Services assets, continuing genetic testing and research. This was an asset transfer through bankruptcy; the acquiring institution and the former listed debtor were distinct legal entities.⁠[12]

Scientific Advisory Board

The nonprofit operating as 23andMe Research Institute announced its inaugural scientific advisory board to guide research priorities, partnerships and funding. Members brought computational-biology, clinical-research and regulatory expertise, reflecting its focus on using consumer genetics resources for research.⁠[13]

ASHG Research Announcement

The institute announced plans for four research presentations at ASHG 2026 in Montreal and described a platform of more than 11 million consented research participants. Topics included rare variants, participant recontact and phenotypic information. Research participation counts are distinct from the total number of testing customers.⁠[14]

California Announces $6 Million Settlement

California’s attorney general announced a $6 million settlement with Chrome Holding Co., formerly 23andMe, over the 2023 breach and bankruptcy asset-transfer disputes. Bankruptcy-court approval remained pending. The counterparty was the former debtor, distinct from the nonprofit that acquired the testing and research businesses.⁠[15]

Products: Ancestry, Health and Clinical Services

Current offerings include Basic Ancestry, Premium Ancestry and Premium Ancestry + Health, spanning ancestry exploration, enhanced family history, and health-risk and carrier reports. Total Health additionally combines exome sequencing, recurring blood testing and clinical support; its scope differs from a basic ancestry kit.⁠[16]

Research Model: Consented Data and Genetic Discovery

23andMe combines consented genetic data with phenotypic information such as health questionnaires to study disease associations and drug targets. Findings can inform insights returned to participants. Large datasets support discovery of associations, but do not by themselves establish causation or demonstrate treatment efficacy.⁠[17]

Privacy: Research Consent, Deletion and Retention

The privacy statement makes research participation optional and allows withdrawal, without undoing completed or published research. Account deletion opts users out of research and discards their samples. Laboratory rules and legal obligations can nevertheless require retention of genetic information and other records; deletion is not immediate erasure of everything.⁠[18]

Interpretation: Genetic Risk Is Not a Diagnosis

The FDA explains that consumer genetic health-risk tests generally cover only selected relevant variants. A positive result does not guarantee disease, and a negative result cannot exclude every risk. Family history, environment and other factors still matter. Interpretation depends on test scope and clinical evaluation rather than replacing diagnosis.⁠[19]

Sources

  1. 23andMe at 16 (opens in a new window)
  2. 23andMe and the FDA (opens in a new window)
  3. FDA authorizes, with special controls, direct-to-consumer test that reports three mutations in the BRCA breast cancer genes (opens in a new window)
  4. GSK and 23andMe sign agreement to leverage genetic insights for the development of novel medicines (opens in a new window)
  5. FDA authorizes first direct-to-consumer test for detecting genetic variants that may be associated with medication metabolism (opens in a new window)
  6. Unaudited Pro Forma Combined Financial Information (opens in a new window)
  7. 23andMe Holding Co. — Form 10-K for the Fiscal Year Ended March 31, 2025 (opens in a new window)
  8. 23andMe Announces Business Restructuring to Streamline Operations, Reduce Costs and Position Company for the Future (opens in a new window)
  9. 23andMe Initiates Voluntary Chapter 11 Process to Maximize Stakeholder Value Through Court-Supervised Sale Process (opens in a new window)
  10. 23andMe fined £2.31 million for failing to protect UK users’ genetic data (opens in a new window)
  11. 23andMe Receives Court Approval for Sale to TTAM Research Institute, a Nonprofit Public Benefit Corporation (opens in a new window)
  12. TTAM Research Institute, A Nonprofit Public Benefit Corporation, Completes The Acquisition of 23andMe Assets (opens in a new window)
  13. 23andMe Research Institute Announces Inaugural Scientific Advisory Board (opens in a new window)
  14. 23andMe Research Institute to Showcase Scientific Impact and Expanded Research Capabilities at ASHG 2026 (opens in a new window)
  15. Attorney General Bonta Secures $6 Million Settlement in 23andMe Litigation (opens in a new window)
  16. 23andMe Research Institute (opens in a new window)
  17. 23andMe Research Institute (opens in a new window)
  18. Privacy Statement (opens in a new window)
  19. Direct-to-Consumer Tests (opens in a new window)