Acu-Gen reports chromosomal abnormalities to pregnant mothers who paid for gender test
Some mothers who paid for the Baby Gender Mentor at-home blood test, which claims to detect an unborn baby's gender just 5 weeks into pregnancy, have gotten a lot more than they bargained for.
Pregnant mom Erin Rivera just thought it would be fun to tell her husband, who is stationed in Afghanistan, the gender of their third child. Instead of "fun", Erin got a shock when a call from Acu-Gen's scientific director, C.N. Wang, informed her that additional tests of her blood sample indicated the possibility of chromosomal abnormalities.
I was crying and crying. I never paid him to find that out.
Erin Rivera
Wang advised Erin to have genetic testing, which would require an amniocentesis to obtain samples of the baby's cells for testing. Because this procedure is expensive and carries a risk of miscarriage, it is only carried out in high risk cases. Following her doctor's advice, Erin decided not to have an amnio, because all other tests indicate that her baby is healthy.
Melissa, another expectant mother, has posted here in the Baby Gender Mentor forum that she, too, got a call from Wang with bad news. Melissa's Baby Gender Mentor test indicated her baby is male, but multiple ultrasounds show that the baby is a girl. After repeated testing, Wang told Melissa that there is "no doubt" her baby has male DNA, but may have a chromosomal defect that can cause malformed genitalia. When the terrified mother asked about the accuracy of this result, she was told only that Acu-Gen's testing is "far more advanced" than other prenatal diagnostics currently available. Rather than enjoying the end of her pregnancy and preparing for her baby girl, Melissa has 10 weeks of agony and worry over her baby's health to endure.
Danielle was also told by Acu-Gen that she should have chromosomal testing performed, after her Baby Gender Mentor result of a boy didn't match several ultrasound exams that showed a girl.
Many other women, who purchased the Baby Gender Mentor test just to satisfy curiosity or to get a head start on decorating the nursery, have found themselves plagued with worries about their baby's health as well. They're asking themselves, "If this gender test is perfect, and 'DNA doesn't lie', what does it mean if Acu-Gen says my baby is a boy but there are no male genitals?" Several have said, "I wish I'd never heard of this test!"
Is this legal?
The question some women are now asking is, why did this lab provide a medical diagnosis when the product is advertised only as a simple gender test?
The US Food and Drug Administration told the company that it did not need approval because the test would not be used for a medical diagnosis.
According to Acu-Gen's C.N. Wang, Boston Globe
Now, however, the test's maker has gone far beyond the original intent, to determine gender only, and has provided a diagnosis on which women might base important healthcare decisions. Faced with the news of a chromosomal or genetic defect, a woman might decide to risk an amniocentesis that would otherwise be deemed unnecessary; worse still, the possibility exists that a woman could choose to terminate a pregnancy based on this "advanced" and supposedly infallible testing.
Yet Acu-Gen has not revealed the methods behind their testing for scientific scrutiny, nor provided any research data that would prove accuracy or provide a false-positive rate. How can a woman's own obstetrician, responsible for the care of mother and unborn baby, have any idea how to evaluate such a claim?
There's no published data as to how well this works. The techniques we used are nowhere near as encouraging as people are being led to believe. It is fraught with potential complications.
Mark Evans, lead investigator of a National Institutes of Health trial on fetal cells in maternal blood