New FDA warning about some non-invasive prenatal screening
tests, the agency warning that pregnant women
should consult a genetic counselor or healthcare
provider beforehand.
Dr. Jen Ashton is here with more.
So tell us a little bit more about these tests.
Robin, this is really a story about the difference
between a screening test and a diagnostic test.
So what we're talking about, and what
the FDA put the alert out about, is a non-invasive blood test.
It's pretty standard in prenatal care in this country.
So over 4 million women get this test
around 10 weeks of pregnancy.
Usually they combine the results with an ultrasound
looking at the fetus.
And what they're trying to screen for
are chromosomal abnormalities like Down syndrome.
The issue is that this is a screening test,
so it is not 100% accurate, and that's why the FDA
is putting out this alert.
Can you give us a little more about why
the FDA is concerned here?
Yeah, so it is about 97% to 99% accurate,
but then if it flags an increased risk for a woman
that that fetus may have a problem with its chromosomes,
the standard of care is an amniocentesis
or a test called a CVS, which is a diagnostic test.
That looks at the DNA.
And what the FDA is worried about
is that women may make incorrect decisions
about continuing their pregnancy based on this result.
You still see patients.
JENNIFER ASHTON: Yep.
If they come in asking you questions about this test,
what are you going to tell them?
Well, it is recommended by ACOG
to do early first-trimester screening of this nature.
However, this is a perfect example.
Anyone can do a test.
It's using the results of that test which
requires medical credentials and judgment
and experience that matters.
So a woman should talk to their midwife,
their obstetrician about what to do
with the results of this test.
And I know you're going to have
a lot more to discuss on GMA3-- - Yep.
You got it. - --later today.
All right, Jen, as always.