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| Name | Class |
|---|---|
| Sequenom, Inc/Laboratory Corporation of America Holdings | UNKNOWN |
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This study plans to evaluate the clinical performance of the MaterniT21 PLUS and/or GENOME Laboratory Developed Test, in the detection of fetal trisomy 21 in circulating cell-free DNA extracted from maternal blood samples obtained from women pregnant with a twin gestation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pregnancies with multiple gestations |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MaterniT21 PLUS and GENOME Laboratory-Developed Tests | Device | Both the MaterniT21 PLUS and GENOME are intended for use as laboratory developed test that analyze ccfDNA extracted from a maternal blood sample utilizing Massively Parallel Sequencing (MPS) technology. |
| Measure | Description | Time Frame |
|---|---|---|
| Determination of sensitivity of NIPT detection of trisomy 21 among a population of women with twin gestations. | time from maternal blood draw to delivery | |
| Determination of specificity of NIPT detection of trisomy 21 among a population of women with twin gestations. | time from maternal blood draw to delivery |
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Inclusion Criteria:
Exclusion Criteria:
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The Study Population will consist of women 18 years of age and older who underwent testing with a Sequenom NIPT, were pregnant with a multiple gestation at the time of testing and whose pregnancies should have outcome based upon gestational age at the time of testing.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39260415 | Derived | Siegel MR, James K, Bromley B, Koelper NC, Chasen ST, Griffin L, Roman AS, Limaye M, Ranzini A, Clifford C, Biggio JR, Subramaniam A, Seasely AR, Page JM, Nicholas SS, Idler J, Rao R, Shree R, McLennan G, Dugoff L; Twin cfDNA Study Consortium. First-Trimester Cell-Free DNA Fetal Fraction and Birth Weight in Twin Pregnancies. Am J Perinatol. 2025 Apr;42(5):605-611. doi: 10.1055/a-2413-2353. Epub 2024 Sep 11. |
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