Prospective NIPT Sample Collection Protocol

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Prospective NIPT Sample Collection Protocol

Brief description of study

This study is being done to develop and validate an investigational noninvasive prenatal test to determine chromosomal anomalies. Pregnant women >10 weeks gestation with positive NIPT results will enroll and provide a blood sample and de-identified health information during a single visit. The samples will be sent to Bio-Rad for development and validation of the investigational assay. Leftover de-identified samples and data are stored for optional future research if subjects provide informed consent. The results of the assay will not be used to guide care and will not be shared with subjects. Bio-Rad will share the de-identified data with the PI for the intent of publication.

Clinical Study Identifier: s21-01262

Principal Investigator: Martin Chavez.

Other Investigators: Anju Suhag, Tracy Adams, Wendy Lyn Kinzler, Sevan Ani Vahanian, Hye Jung Heo, Genevieve B Sicuranza, Lakha Prasannan, Nadia Bennett Kunzier.

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