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 |
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.
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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28
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Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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University of Maryland As a globally-connected university offering a world-class education, the University of Maryland...
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University of Cincinnati The University of Cincinnati offers students a balance of educational excellence and...
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University of Kansas Medical Center The University of Kansas Medical Center serves Kansas through excellence...
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Saint Luke's Hospital, Kansas City Saint Luke's Hospital is a not-for-profit tertiary referral center committed...
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University of South Alabama "University of South Alabama is a public institution that was founded...
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940 NE 13th St
Oklahoma City, Oklahoma 73190
Oklahoma City, Oklahoma 73190
(405) 271-6458
University of Oklahoma Health Sciences Center The OU Health Sciences Center is composed of seven...
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