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23andme personal genome service pgs genetic health risk test for hereditary thrombophilia
23Andme
Summary: The 23andme Personal Genome Service is a genetic health risk test for hereditary thrombophilia, primarily used to assess genetic predisposition to blood clotting disorders. Key evidence includes FDA clearance and studies on polygenic risk scores.
FDA Clearance Information
Pathway
510K
Number
DEN160026 ↗
Decision Date
April 6, 2017
Product Code
PTA
Device Class
Class 2
Evidence
419 studies
The 23andme Personal Genome Service was cleared by the FDA through the 510(k) pathway on April 6, 2017. It is manufactured by 23Andme and classified as a Class 2 medical device.
What It Is
The 23andme Personal Genome Service is a genetic test designed to assess the risk of hereditary thrombophilia by analyzing specific genetic markers. It is intended for use in identifying individuals at increased risk of developing blood clotting disorders.
Clinical Applications
This device is commonly used in clinical scenarios where there is a need to evaluate a patient's genetic predisposition to thrombophilia, particularly in individuals with a family history of blood clotting disorders or unexplained thrombotic events.
Evidence Summary
The available literature includes four studies, with types ranging from retrospective analyses to discussions on regulatory actions. The studies span from 2015 to 2026, involving large cohorts for genetic association studies.
Reported Outcomes
Published studies report on the development and application of polygenic risk scores for various traits, including body mass index and cannabis use. However, specific outcomes related to hereditary thrombophilia were not detailed in the provided evidence.
Safety Profile
Reported complications include regulatory challenges and privacy concerns associated with direct-to-consumer genetic testing. No specific adverse events related to the genetic health risk test for hereditary thrombophilia were noted in the evidence provided.
Evidence Limitations
The evidence provided lacks specific clinical outcomes related to hereditary thrombophilia. Further research is needed to validate the clinical utility of the test in diverse populations and to explore potential adverse effects.
Linked Studies (20)
PubMed • 2025
Onyx Liquid Embolic Agent: Basic Knowledge for Its Use in Interventional Neuroradiology.
Journal of neuroendovascular therapy
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Performance evaluation of quantitative hemoglobin A2 and fetal hemoglobin testing using commercially lyophilized vs. in-house whole blood controls in Chinese clinical laboratories: a 12-year analysis of National External Quality Assessment Data.
Clinical chemistry and laboratory medicine
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Clinical progress note: Haemophilus influenzae type b.
Journal of hospital medicine
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Pilot study of social media promotion of home-based self-testing for syphilis.
Sexually transmitted diseases
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Clinical development and performance of the First to Know Syphilis Self-Test for over-the-counter usage: a de novo rapid test for treponemal antibody.
Journal of clinical microbiology
View Source →
PubMed • 2025
Implementation of an Opt-Out and Rapid Point-of-Care Syphilis Testing Program for Pregnant Patients Presenting to the Emergency Department.
Sexually transmitted diseases
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Evaluation of Rapid Syphilis Testing Using the Syphilis Health Check in Florida, 2015-2016.
Florida public health review
View Source →
PubMed • 2025
Multiplex droplet digital PCR for the detection and quantitation of Streptococcus pneumoniae, Mycoplasma pneumoniae, and Haemophilus influenzae.
Frontiers in cellular and infection microbiology
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Palm Multidiagnostic of Mycoplasma pneumoniae, Chlamydia pneumoniae, Haemophilus influenzae, and Streptococcus pneumoniae Using One-Tube CRISPR/Cas12a.
Transboundary and emerging diseases
View Source →
PubMed • 2025
Tp40: a new potential prognostic and diagnostic marker for syphilis.
Microbiology spectrum
View Source →
PubMed • 2025
Serotonin sets up neutrophil extracellular traps to promote neuroendocrine prostate cancer metastasis in the liver.
The Journal of clinical investigation
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Application value of Philips Ingenuity TF PET/CT scanner imaging agent FAP in evaluating renal fibrosis.
Hellenic journal of nuclear medicine
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Message from Dr. Philippe T. Georgel, Guest Editor for the Marshall University Collection, Brad D. Smith, President of Marshall University, and Dr. Anivandan Mukherjee, Provost of Marshall University.
Biochemistry and cell biology = Biochimie et biologie cellulaire
View Source →
PubMed • 2025
Improved patient comfort and procedural efficiency using chlorhexidine-coated hydrophilic urethral catheters: a randomized controlled trial.
Journal of Yeungnam medical science
RCT View Source →
PubMed • 2025
pTx-Pulseq in hybrid sequences: Accessible and advanced hybrid open-source MRI sequences on Philips scanners.
Magnetic resonance in medicine
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Comparative connectomics of Drosophila descending and ascending neurons.
Nature
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Hydrophilic-coated sheaths for reducing radial artery spasm during transradial procedures: A systematic review and meta-analysis.
Interventional neuroradiology : journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences
View Source →
PubMed • 2025
History of antineutrophil cytoplasmic autoantibodies : Milestones in rheumatology.
Zeitschrift fur Rheumatologie
View Source →
PubMed • 2025
A Hydrophilic Polyurethane Foam Containing Nigella sativa Oil as a Wound Dressing.
BioMed research international
RCT|prospective|retrospective|case Series|other View Source →Frequently Asked Questions
What are the clinical indications for 23andme personal genome service?
The device is indicated for assessing genetic risk factors associated with hereditary thrombophilia.
What outcomes have been reported in clinical studies?
Specific outcomes related to hereditary thrombophilia were not detailed in the provided evidence.
What complications have been reported?
Reported complications include regulatory challenges and privacy concerns, with no specific adverse events noted for hereditary thrombophilia testing.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.