Clinical Evaluation of the SEQureDx T21 Test In High Risk Pregnancies



Status:Completed
Conditions:Other Indications
Therapuetic Areas:Other
Healthy:No
Age Range:18 - 60
Updated:4/21/2016
Start Date:March 2012
End Date:December 2015

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A Clinical Study to Evaluate the Clinical Performance of the SEQureDx Trisomy 21 Test in the Detection of the Relative Quantity of Chromosome 21 in Circulating Cell-Free DNA Extracted From a Maternal Blood Sample Obtained From Pregnant Women With One or More High Risk Indicators for Fetal Chromosome 21 Aneuploidy

Whole blood samples will be collected from high-risk pregnant women to validate the clinical
performance of the SEQureDx Trisomy 21 Test.


Inclusion Criteria:

- Pregnant woman 18 years of age or older at 10 - 22 weeks gestation inclusive

- Subject has one or more high risk indicator for fetal chromosome 21 aneuploidy

- Subject provides signed and dated informed consent

- Subject agrees to provide a whole blood sample

Exclusion Criteria:

- Fetal demise at the time of the blood draw

- Previous specimen donation under this protocol
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8700 Beverly Blvd # 8211
Los Angeles, California 90048
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Campbell, California 95008
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2600 Clifton Ave
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Columbus, Ohio 43231
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Honolulu, Hawaii 96813
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Iowa City, Iowa 52242
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3901 Rainbow Blvd
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4401 Wornall Rd
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Long Beach, California 90801
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Miami, Florida 33175
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307 N University Blvd
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940 NE 13th St
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