Expectant parents always want to know what’s in store for their baby to be. Unfortunately, too many of the prenatal tests simply fail to provide accurate results.
As such (or is that FINALLY?), the FDA is taking the authority to oversee these tests, these screening and diagnostic systems, to ensure better results. (The FDA ran away from regulating these tests nearly a decade ago.)
This probably means that the vendors for these tests would have to submit their tests for FDA approval.
One should note that the tests for the more common genetic disorders are pretty accurate. It’s the ones that claim to detect the rare abnormalities that fall far short of the accuracy needed. (How about wrong at least 80% and almost 93% of the time?) Which means the parents shell out big bucks to follow up on these results, often to find that there is nothing wrong.
(While we are at it, we should note that the FDA is also beginning to monitor those tests used in clinical cancer drug trials.)
It is expected that a draft of the FDA’s new proposed rule should be published before Labor Day. And, we can expect significant pushback from vendors during the review process.
So, we shouldn’t be expecting rapid changes in this arena.
It’s very sensitive and tricky problem. I hope ethical practices become more common .
Ah, yes, hopeful ethical practice.
Maybe we can find a way for that to trump those seeking fortunes
I am conflicted about prenatal testing. I mean, the only reason to do it is because you’re hoping for a healthy baby and peace of mind – but what if you got told something may be wrong? What will you do? Depending on where you live, you can’t abort anyway, so you will spend the upcoming month tossing and turning and worrying. Best case you give birth to a healthy baby anyway, but you’ve been feeding your unborn child all those negative stress hormones.
To some degree, that is the dilemna I discern, too, Tamara. Sometimes, knowledge does not provide any comfort- just discomfort.
Wow, those “wrong” statistics are stunning! I honestly don’t trust conventional medicine very much and reading things like this don’t help any.
We just need accurate testing, so we can all stay safe, Jeanine.
Interesting read
Thanks, Kate
I’m not sure I like the government regulating more things, but in this case, it is important. Parents need to have correct results, as well as doctors, so that after-birth care can be provided. Thanks for sharing this information!
This is why there is government regulation- too many charlatans pushing bad solutions, Angie!
Up to 93% wrong?? Not a few good track record!
That is the understatement of the year, Martha!
Those statistics are horrifying in so many ways even if the tests for more common issues are more accurate.
I wholeheartedly agree, Alana!