trait and sex selection: the arrival of non -invasive prenatal genetic testing

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Trait and Sex Selection: The Arrival of Non-Invasive Prenatal Genetic Testing Jaime King, JD, PhD University of California, Hastings College of the Law Tarrytown Meeting July 26, 2011

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Trait and Sex Selection: The Arrival of Non -Invasive Prenatal Genetic Testing. Jaime King, JD, PhD University of California, Hastings College of the Law Tarrytown Meeting July 26, 2011. Contents of Maternal Blood Serum. Non-Invasive Prenatal Diagnosis. No Brave New World?. - PowerPoint PPT Presentation

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Page 1: Trait and Sex Selection: The Arrival of Non -Invasive Prenatal Genetic  Testing

Trait and Sex Selection: The Arrival of Non-Invasive Prenatal

Genetic Testing

Trait and Sex Selection: The Arrival of Non-Invasive Prenatal

Genetic Testing

Jaime King, JD, PhD

University of California, Hastings College of the Law

Tarrytown Meeting

July 26, 2011

Jaime King, JD, PhD

University of California, Hastings College of the Law

Tarrytown Meeting

July 26, 2011

Page 2: Trait and Sex Selection: The Arrival of Non -Invasive Prenatal Genetic  Testing

Contents of Maternal Blood Serum

Contents of Maternal Blood Serum

Page 3: Trait and Sex Selection: The Arrival of Non -Invasive Prenatal Genetic  Testing

Non-Invasive Prenatal DiagnosisNon-Invasive Prenatal Diagnosis

Page 4: Trait and Sex Selection: The Arrival of Non -Invasive Prenatal Genetic  Testing

No Brave New World?No Brave New World?

Page 5: Trait and Sex Selection: The Arrival of Non -Invasive Prenatal Genetic  Testing

Critical Features of NIPDCritical Features of NIPD

Non-Invasive

Timing

Comparatively Less Expensive

Non-Invasive

Timing

Comparatively Less Expensive

Page 6: Trait and Sex Selection: The Arrival of Non -Invasive Prenatal Genetic  Testing

Non-Invasive Prenatal Genetic Diagnosis (NIPD)

Non-Invasive Prenatal Genetic Diagnosis (NIPD)

Page 7: Trait and Sex Selection: The Arrival of Non -Invasive Prenatal Genetic  Testing

Current Prenatal Genetic DiagnosisCurrent Prenatal Genetic Diagnosis

AmniocentesisAmniocentesis

Chorionic Villus SamplingChorionic Villus Sampling

Page 8: Trait and Sex Selection: The Arrival of Non -Invasive Prenatal Genetic  Testing

Non-Invasive Prenatal Diagnostic Testing Timeline

Non-Invasive Prenatal Diagnostic Testing Timeline

4-5 Weeks - Earliest Detection of cell free fetal DNA (cff DNA)

7-9 Weeks - Commercial Sex Determination

9 Weeks - Reliable Genetic Testing 7-10 Weeks - Reliable Aneuploidy Testing

4-5 Weeks - Earliest Detection of cell free fetal DNA (cff DNA)

7-9 Weeks - Commercial Sex Determination

9 Weeks - Reliable Genetic Testing 7-10 Weeks - Reliable Aneuploidy Testing

Page 9: Trait and Sex Selection: The Arrival of Non -Invasive Prenatal Genetic  Testing

Current Prenatal Screening Timeline

Current Prenatal Screening Timeline

The California Prenatal Screening Program, Patient Booklet, March 2009

Diagnostic Tests- Chorionic Villus Sampling - 10-13 weeks- Amniocentesis - 15+ weeks (preferred)

Page 10: Trait and Sex Selection: The Arrival of Non -Invasive Prenatal Genetic  Testing

CostsCosts

T21 – Steven Quake predicts testing costs will be ~ $300 for Down Syndrome.

Prenatal Screening ~ $200 Ultrasound ~$300

Amniocentesis and CVS ~ $1500

T21 – Steven Quake predicts testing costs will be ~ $300 for Down Syndrome.

Prenatal Screening ~ $200 Ultrasound ~$300

Amniocentesis and CVS ~ $1500

Page 11: Trait and Sex Selection: The Arrival of Non -Invasive Prenatal Genetic  Testing

Non-Invasive+Early+Low Cost = High Volume

Non-Invasive+Early+Low Cost = High Volume

Page 12: Trait and Sex Selection: The Arrival of Non -Invasive Prenatal Genetic  Testing

Major UsesMajor Uses Sex Determination Diagnosis of Fetal Blood Type Detection of Fetal Aneuploidy Diagnosis of Single Gene Disorders Susceptibility to Multigene and Complex

Genetic Disorders Genome Wide Analysis

Sex Determination Diagnosis of Fetal Blood Type Detection of Fetal Aneuploidy Diagnosis of Single Gene Disorders Susceptibility to Multigene and Complex

Genetic Disorders Genome Wide Analysis

Page 13: Trait and Sex Selection: The Arrival of Non -Invasive Prenatal Genetic  Testing

Initial Implementation Challenges

Initial Implementation Challenges

Page 14: Trait and Sex Selection: The Arrival of Non -Invasive Prenatal Genetic  Testing

Who will offer NIPD?Who will offer NIPD?

PhysiciansPhysicians Biotechnology CompaniesBiotechnology Companies

Both?

Page 15: Trait and Sex Selection: The Arrival of Non -Invasive Prenatal Genetic  Testing

Commercial Sex DetectionCommercial Sex Detection

Page 16: Trait and Sex Selection: The Arrival of Non -Invasive Prenatal Genetic  Testing

What Tests to Offer?What Tests to Offer?

Page 17: Trait and Sex Selection: The Arrival of Non -Invasive Prenatal Genetic  Testing

How to Inform Patients?How to Inform Patients?

Page 18: Trait and Sex Selection: The Arrival of Non -Invasive Prenatal Genetic  Testing

2 Step Informed Consent Model2 Step Informed Consent Model

Page 19: Trait and Sex Selection: The Arrival of Non -Invasive Prenatal Genetic  Testing

Longer Term Implementation Concerns

Longer Term Implementation Concerns

Routinization of Prenatal Genetic Testing

Regulating Reproductive Autonomy

Routinization of Prenatal Genetic Testing

Regulating Reproductive Autonomy

Page 20: Trait and Sex Selection: The Arrival of Non -Invasive Prenatal Genetic  Testing

Thank You Thank You