Trait and Sex Selection The Arrival of NonInvasive

Trait and Sex Selection: The Arrival of Non-Invasive Prenatal Genetic Testing Jaime King, JD, Ph. D 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?

Critical Features of NIPD § Non-Invasive § Timing § Comparatively Less Expensive

Non-Invasive Prenatal Genetic Diagnosis (NIPD)

Current Prenatal Genetic Diagnosis Amniocentesis Chorionic Villus Sampling

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

Current Prenatal Screening Timeline Diagnostic Tests - Chorionic Villus Sampling - 10 -13 weeks - Amniocentesis - 15+ weeks (preferred) The California Prenatal Screening Program, Patient Booklet, March 2009

Costs § T 21 – 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

Major 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

Initial Implementation Challenges

Who will offer NIPD? Physicians Biotechnology Companies Both?

Commercial Sex Detection

What Tests to Offer?

How to Inform Patients?

2 Step Informed Consent Model

Longer Term Implementation Concerns § Routinization of Prenatal Genetic Testing § Regulating Reproductive Autonomy

Thank You