Book contents
- Personal Genome Medicine
- Personal Genome Medicine
- Copyright page
- Dedication
- Contents
- Reader’s Note
- Acknowledgments
- Prologue
- 1 Medical Profession Sovereignty to Protect and Promote the Science and Evidence Base of US Medicine
- 2 US Integration of Government, Academia, and Industry
- 3 Direct-to-Consumer/DTC and Direct-to-Physician/DTP Biopharma Marketing in the US
- 4 The Evolution of Consumer Genetic Testing Services from Oncormed, Inc. to 23andMe Holding Co.
- 5 Vulnerability of the Science and Evidence Base of US Medicine
- 6 A Warning Label for Direct-to-Consumer/DTC Genetics and Genomics
- 7 Protecting and Promoting the Evidentiary-Science Base of Personal Genome Medicine/PGM
- Epilogue
- Index
4 - The Evolution of Consumer Genetic Testing Services from Oncormed, Inc. to 23andMe Holding Co.
Published online by Cambridge University Press: 30 August 2023
Book contents
- Personal Genome Medicine
- Personal Genome Medicine
- Copyright page
- Dedication
- Contents
- Reader’s Note
- Acknowledgments
- Prologue
- 1 Medical Profession Sovereignty to Protect and Promote the Science and Evidence Base of US Medicine
- 2 US Integration of Government, Academia, and Industry
- 3 Direct-to-Consumer/DTC and Direct-to-Physician/DTP Biopharma Marketing in the US
- 4 The Evolution of Consumer Genetic Testing Services from Oncormed, Inc. to 23andMe Holding Co.
- 5 Vulnerability of the Science and Evidence Base of US Medicine
- 6 A Warning Label for Direct-to-Consumer/DTC Genetics and Genomics
- 7 Protecting and Promoting the Evidentiary-Science Base of Personal Genome Medicine/PGM
- Epilogue
- Index
Summary
In the years following FDA approval of direct-to-consumer, genetic-health-risk/DTCGHR testing, millions of people in the US have sent their DNA to companies to receive personal genome health risk information without physician or other learned medical professional involvement. In Personal Genome Medicine, Michael J. Malinowski examines the ethical, legal, and social implications of this development. Drawing from the past and present of medicine in the US, Malinowski applies law, policy, public and private sector practices, and governing norms to analyze the commercial personal genome sequencing and testing sectors and to assess their impact on the future of US medicine. Written in relatable and accessible language, the book also proposes regulatory reforms for government and medical professionals that will enable technological advancements while maintaining personal and public health standards.
Keywords
consumer genetic testing servicesOncormed23andMe23andMe Holding Co.Personal Genome ServiceDNA mystiqueHuman Genome Project (HGP)innovative new drugsbiologicsgenomicsallelesmap of the human genomehuman genome sequencebiotechinformation and communication technologygenetic privacygenetic discriminationHealth Insurance Portability Accountability Act (HIPAA)Genetic Information and Nondiscrimination Act (GINA)protected health information (PHI)Affordable Care Act (ACA)direct-to-consumer (DTC) marketinggenetic ancestryparticipatory health movementpatient self-determination movementgenomic sciencehealth-related genetic testing servicesgenetic health risk tests/testingmedical autonomyAnne WojcickiBRCAinstitutional review board (IRB)Genetics & IVF InstituteMyriad Genetic LaboratoriesMyriad GeneticsTask Force on Genetic Testinghome brew testingClinical Laboratory Improvement Act (CLIA)predictive genetic testingLeroy HoodDavid Baltimorerecombinant DNANational Breast Cancer Coalition (NBCC)Francis Collinsgenetic counselingbiobanksDNA sequencing technologyproteomic testsHIPAA Privacy RuleHIPAA Security RuleGeorge AnnasThe Genetics Privacy ActSecretary’s Advisory Committee on Genetic Testing (SACGT)genetic exceptionalismBiotechnology Industry Organization/Biotechnology Innovation Organization (BIO)Pharmaceutical Research and Manufacturers of America (PhRMA)Angelina Joliepositive predictive value (PPV)the Angelina effectmethod/process patentspersonalized medicinepharmacogeneticspharmacogenomicssingle nucleotide polymorphisms (SNPs)DNA genealogydeCODE GeneticsdeCODEmeDNA microarrayIlluminaDNA profileJames Watsonconsumer comprehensionCenter for Devices and Radiological Health (CDRH)FDA special controlspremarket notification (PMN)GlaxoSmithkline (GSK)drug target discovery510(k) applicationanalytic validityclinical proficiencyclinical utilityFDA special controlsAncestry.comAncestryHealthVG Acquisition Corp.Lemonaid Healthconsumer DNA testingcommercial exploitationJohn Craig Ventershotgun sequencingCommon RuleSecretary’s Advisory Committee on Genetic Testing (SACGT)Clinical Laboratory Improvement Act (CLIA)Clinical Laboratory Improvement Amendmentsgenomic revolutionEthical, Legal, and Social Implications Program (ELSI)Dana–Farber Cancer InstituteNational Breast Cancer Coalition (NBCC)$1,000 GenomeSergey BrinIlluminaphenotypic dataMedical Devices ActMedical Device Amendmentssection 510(k)Prescription Drug User Fee Act (PDUFA)Food and Drug Administration Modernization Act (FDAMA)AncestryDNAConsumer Genetic Technologies
- Type
- Chapter
- Information
- Personal Genome MedicineThe Legal and Regulatory Transformation of US Medicine, pp. 158 - 201Publisher: Cambridge University PressPrint publication year: 2023