Although Acu-Gen has previously refused to provide any evidence from trials to support their accuracy claims, or to reveal sales figures or details behind their method, that may change as the company has now been subpoenaed by the Attorney General's office.
Both officials were alarmed b the experience of Florida mother Erin Rivera, who purchased the Baby Gender Mentor test just to learn whether her unborn baby was a boy or a girl. Erin was told by Acu-Gen's Wang that her baby had Trisomy-18, and would likely die at birth. When questioned about Erin's case by ABC Tampa's Linda Hurtado, Wang said:
Aside from the anguish endured by this frightened pregnant mother, there is very real danger in this sort of diagnosis: most babies diagnosed prenatally with a trisomy, such as Down's Syndrome, are aborted before birth.
Thankfully, Erin Rivera never considered that option, and in March delivered a perfectly healthy baby boy named Lucas.
Congressman Jim Davis has sent a letter to FDA commissioner Dr. Andrew von Eschenbach regarding the Baby Gender Mentor; here are some excerpts:
I am writing to call on the FDA to investigate Acu-Gen's Baby Gender Mentor test and provide oversight for similar gender tests to protect consumers from false medical diagnoses.
...There have been numerous cases where Acu-Gen predicted false and misleading results for the customers. Furthermore, Acu-Gen refused to give these customers their guaranteed refund after they showed proof the test results were wrong. The company cannot supply scientific data or proof of any clinical trials supporting the test's accuracy.
...It is my understanding that the FDA does not regulate this test, because they consider it a 'home brew' test. Dr. Eschenbach, this is very troubling and alarming that no one is monitoring what is happening with these companies...
Why is the FDA not monitoring these companies in the light of the claims being made? Is the FDA equipped to monitor these companies? Do you agree more oversight is needed for products like Baby Gender Mentor?
...I am very concerned with the lack of gevoerment oversight companies like Acu-Gen receive, especially in light that they are now making false medical diagnoses.
Excellent questions, Mr. Davis. Why doesn't the FDA monitor these
companies? The answer is that, because of a loophole in FDA
policy, a company may sell genetic testing as a lab service without FDA
approval. Thus, there is no oversight to assure consumers that
genetic tests are accurate, or even useful for the advertised intent.
If this seems like a bad situation to you, Mr. Davis, you aren't alone. For over a decade, federal advisory boards have been calling for regulation of genetic testing. Five years ago, the CDC promised to do so,
yet still nothing has been done. So, although it's already been 8
weeks since you sent your letter to the FDA, don't be too surprised if
you don't hear anything back soon.
- How to Petition the FDA to change or create policy
Anyone may petition the FDA, and the FDA must respond within 180 days - ABC Tampa's Linda Hurtado reports Florida congressman urges FDA to investigate Baby Gender Mentor and similar products; Florida attorney general investigates Acu-Gen
Well done Linda!
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