The big business behind prenatal testing and why it’s raising red flags with doctors

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(May 10, 2015) — Ashleigh Moon faced a horrible decision just weeks into her pregnancy.  There were signs her baby might have serious health issues before it was even born.

So Ashleigh had a prenatal exam, which consisted of measuring a fetal protein, and an ultrasound.  The results came back, that her baby was at risk for Down Syndrome, Spina bifida and a more rare genetic defect called Edward’s Syndrome.  Frightened,  Ashleigh   decided to take a chance and continue the pregnancy.  When  her son was born she got the shock of her life. He was perfect in every way and the tests had been wrong.

Prenatal tests today are much more accurate than the one Ashleigh Moon had.  Today’s are called cell free DNA tests, which examine fetal DNA retrieved from the mother’s bloodstream.

These screens or tests are also considered noninvasive, which translates to a lower risk of problems for the mother and the baby.

There are a number of these noninvasive cell free DNA tests: MaterniT21, Panorama, Progenity and Harmony are just a few.  Each brand has a website.  For this report, we wanted to find clear, easy to understand information about the tests themselves and their accuracy.

We found all of the websites contained statements about being accurate.  All of them also said, there was a slight chance a patient would get a false positive or false negative result.

Dr. Lee Shulman, who is a consultant for MaterniT21, admitted the information on the website, isn’t all that useful.

“The website is not a substitute for counseling,” said Dr. Shulman.  “The website is informational as well as promotional, Part of the website is, we’re better than them, we have nicer, cuter baby pictures, whatever it is. But the website is not the source or ultimate source for information that is specifically appropriate for that individual woman.”

We asked Obstetrician and Gynecologist Dr. Barbara Matakevich about the accuracy of these prenatal tests.

“It screens best for Trisomy 21, which is Down Syndrome. It’s pretty good for Trisomy 18, which is Edward’s Syndrome. It’s ok for Trisomy 13, which is less frequent.”

So these cell free DNA tests are very good, but they aren’t perfect.

Critics charge that making a decision about whether or not to keep a fetus, should not be made by these unregulated tests.  In fact, thee tests have not been cleared or approved by the FDA.

But some mothers-to-be, treat these screens like they are 100 percent accurate.

Dr. Christina Francis an OB/GYN of Fort Wayne.

“We should not be making decisions neither to manage a pregnancy or what to do with a pregnancy, based on the result of this test alone.”

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