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This study will obtain whole blood specimens from healthy subjects to be used for research and development and clinical validation of genetic assays.
Progenity is developing diagnostic products to improve the healthcare of men, women, and children. The commercial objective is to make safe, noninvasive genetic testing available to the public, independent of age and other factors that may contribute to pregnancy or other clinical complications.
Sample specimens will not be used to develop genetic lines and/or DNA banks for cloning. Any samples or remnant specimens remaining may be stored indefinitely for future research programs.
Eligible subjects (or parent/guardian) will provide written informed consent after which basic demographic and clinical data will be obtained and a whole blood sample will be collected. A subject's participation may end immediately after their blood draw. The amount of whole blood drawn at any visit will be based upon age of the subject and test to be performed.
In the event a Subject is pregnant, information regarding the gender of the fetus established by either ultrasound, non-invasive prenatal testing (NIPT) results, or at delivery will be collected. Clinical data regarding any karyotyping procedure that may occur on the fetus will be recorded.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Whole blood from all ages and gender | - Ages from 0 to Adults (18 yrs of age or older) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Whole blood | Other |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Whole blood collection | Whole blood collection from 750 healthy subjects total | about 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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Men, pregnant women or children, no age restrictions.
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| Name | Affiliation | Role |
|---|---|---|
| Peter Stiegler, PhD | Head of Clinical Affairs | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Heinen Obstetrics & Gynecology | Eunice | Louisiana | 70535 | United States | ||
| Virtua Medical Group |
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Whole blood samples
| Voorhees Township |
| New Jersey |
| 08043 |
| United States |
| Cincinnati Obgyn | Cincinnati | Ohio | 45219 | United States |