MatErnal BLood IS Source to Accurately Diagnose Fetal Aneuploidy

Overview

The primary objective of this study is to determine the performance characteristics (sensitivity and specificity) of the Verinata Health Test to detect fetal Trisomy 21 (T21) compared to karyotype results obtained by amniocentesis or chorionic villus sampling (CVS). Secondary objectives are to assess performance of the test to detect male gender (XY) and other less common aneuploidies (Trisomy 13 (T13), Trisomy 18 (T18), and Turner Syndrome (45, X)) compared to clinical fetal karyotype.

Full Title of Study: “A Prospective, Multi-center Observational Study With Blinded, Nested Case:Control Analyses to Evaluate the Performance of the Verinata Health Prenatal Aneuploidy Diagnostic Test”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: September 2011

Arms, Groups and Cohorts

  • Chromosomal Abnormality
    • Fetus affected by chromosomal abnormality
  • No Chromosomal Abnormality
    • Fetus not affected by chromosomal abnormality

Clinical Trial Outcome Measures

Primary Measures

  • Classification of fetal status as affected or not affected for Trisomy 21 based on Artemis Health Test on maternal blood.
    • Time Frame: 10 months

Participating in This Clinical Trial

Inclusion Criteria

  • Age 18 years or older – Clinically confirmed viable pregnancy at the time of enrollment – Clinically determined gestational age between 8 wks, 0 days and 22 wks, 0 days – Referred or planning to undergo CVS or amniocentesis procedure due to risk of fetal aneuploidy based on protocol-specified clinical indicators – Able to provide consent for participation using language appropriate forms and consent process Exclusion Criteria:

  • Invasive prenatal procedure (amniocentesis or CVS) performed prior to enrollment

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Verinata Health, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Amy J Sehnert, MD, Study Director, Verinata Health, Inc.

References

http://www.clinchem.org/cgi/content/abstract/clinchem.2011.165910

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