trait and sex selection: the arrival of non-invasive prenatal genetic testing jaime king, jd, phd...

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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

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

Contents of Maternal Blood Serum

Contents of Maternal Blood Serum

Non-Invasive Prenatal DiagnosisNon-Invasive Prenatal Diagnosis

No Brave New World?No Brave New World?

Critical Features of NIPDCritical Features of NIPD

Non-Invasive

Timing

Comparatively Less Expensive

Non-Invasive

Timing

Comparatively Less Expensive

Non-Invasive Prenatal Genetic Diagnosis (NIPD)

Non-Invasive Prenatal Genetic Diagnosis (NIPD)

Current Prenatal Genetic DiagnosisCurrent Prenatal Genetic Diagnosis

AmniocentesisAmniocentesis

Chorionic Villus SamplingChorionic Villus Sampling

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

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)

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

Non-Invasive+Early+Low Cost = High Volume

Non-Invasive+Early+Low Cost = High Volume

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

Initial Implementation Challenges

Initial Implementation Challenges

Who will offer NIPD?Who will offer NIPD?

PhysiciansPhysicians Biotechnology CompaniesBiotechnology Companies

Both?

Commercial Sex DetectionCommercial Sex Detection

What Tests to Offer?What Tests to Offer?

How to Inform Patients?How to Inform Patients?

2 Step Informed Consent Model2 Step Informed Consent Model

Longer Term Implementation Concerns

Longer Term Implementation Concerns

Routinization of Prenatal Genetic Testing

Regulating Reproductive Autonomy

Routinization of Prenatal Genetic Testing

Regulating Reproductive Autonomy

Thank You Thank You