Vidcast:  https://youtu.be/UEBi_YtxlCU

 

The FDA is now warning prospective parents should not =base a decision to terminate a pregnancy on so-called non-invasive prenatal screening tests or NIPS for short.  These tests are laboratory developed tests and are offered for sale without any FDA review of their accuracy and precision.  They are not FDA authorized, cleared, or approved.

 

These tests are often marketed as “reliable and highly accurate,” but the solid scientific studies to support such claims are often missing.  These tests are not formal chromosomal analyses but rely on the testing of small fragments of fetal DNA circulating in the mother’s blood to predict if an actual chromosomal anomaly exists.  Sometimes such genetic misfires exist only in the placenta while the fetus itself has a normal chromosomal complement.

 

Any fetal abnormalities predicted by these NIPS MUST be confirmed with a formal fetal chromosomal analysis, an FDA approved diagnostic test, before any decisions based on the presence or absence of a potentially devastating genetic disease can be made.  These genetic tests require amniocentesis or chorionic villous sampling, and both procedures do carry a small risk of miscarriage.

 

The decision to perform non-invasive screening tests and confirmatory, invasive formal genetic testing should always be discussed with a qualified genetic counselor.  Screening tests only suggest a given genetic abnormality may be present or absent.  They do not prove it.

 

https://www.fda.gov/medical-devices/safety-communications/genetic-non-invasive-prenatal-screening-tests-may-have-false-results-fda-safety-communication

 

#pregnancy #geneticscreening #FDA #abortion #chromosomes