Healthy Volunteers Clinical Trial
Official title:
Whole Blood Specimen Collection From Healthy Subjects
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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