Clinical Performance of the MaterniT21 PLUS LDT in Multiple Gestation Pregnancies

Sequenom, Inc.50 enrolled

Overview

This study will evaluate the clinical performance of massively parallel sequencing (MPS) using the MaterniT21 PLUS LDT in the detection of fetal aneuploidy in circulating cfDNA extracted from a maternal blood sample obtained from women pregnant with a multiple gestation who were at increased risk for fetal aneuploidy.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Down Syndrome Edwards Syndrome Patau Syndrome Turner Syndrome

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Subject was pregnant with a multiple gestation and received NIPT with the MaterniT21 PLUS LDT and a valid test result is available; * Subject was 18 years of age or older at the time of NIPT; * Subject provides signed and dated informed consent in English; Exclusion Criteria: * Subjects' treating physician is not located in the United States.

Locations (1)

Presbyterian/St. Luke's Medical Center

Denver, Colorado, United States

Outcomes

Primary Outcomes

Clinical Performance (Sensitivity/Specificity) of MaterniT21 PLUS LDT Assay

Results of the MaterniT21 PLUS LDT will be compared to the pregnancy outcome data obtained from the patient

Time frame: Subjects contacted within 3 years after pregnancy is completed

Data from ClinicalTrials.gov

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