c. 2005 Religon News Service

(UNDATED) With her husband serving in Afghanistan, Erin Rivera thought it would be fun to let him know the gender of their third child within weeks of her positive pregnancy test. So she purchased a Baby Gender Mentor test kit, which claims to be 99.9 percent accurate in detecting gender through fetal DNA in maternal blood samples.

Three weeks after results indicated she was carrying a boy, Rivera got a call from C.N. Wang, scientific director of Acu-Gen Labs Inc., the Lowell, Mass., company that performs the test. Wang said she should have genetic testing because he detected an elevated level of fetal protein in her blood, which sometimes indicates chromosomal abnormalities.

“I was crying and crying. I never paid him to find that out,” said Rivera, of Tampa, Fla.

As reproductive technology advances, new, unanticipated ethical questions are arising even as critics challenge the very accuracy of tests like the one Rivera took. Taken together, these challenges could derail the emerging niche industry.

“It’s important for patients to understand what tests they’re having, what potential information might be revealed, and how this information might and might not be used,” said Jeff Ecker, chairman of the committee on ethics for the American College of Obstetrics and Gynecology and a high-risk obstetrician at Massachusetts General Hospital.

Finding inadvertent information “happens all the time in genetic testing,” said Arthur Caplan, chairman of the department of medical ethics at the University of Pennsylvania School of Medicine. “You can find out about paternity or disease. People don’t know what they’re getting into.”

Wang said his findings required him to contact Rivera, even though he acknowledged the informed consent that accompanies the test does not demand it.

“I struggled with it myself, saying I could just ignore it and walk away,” said the molecular biologist. “But that would haunt me the rest of my life.”

Meanwhile, a small but growing number of women are claiming the gender tests are not as reliable as ultrasound and amniocentesis. Because embryonic DNA is present in maternal blood, the sample is tested for the presence of the Y chromosome, which indicates a male. If there is no Y chromosome, the embryo is female.

It is difficult for experts to assess Acu-Gen’s accuracy claims because the company has not published its research data, citing pending patent registration.

Mark Evans, a lead investigator of a National Institutes of Health trial on fetal cells in maternal blood, questioned the test.

“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,” said Evans, a professor at Mount Sinai Medical School who also runs a private prenatal testing clinic in Manhattan. “It is fraught with potential complications.”

There are two reasons the test could be flawed, experts said. First, it might involve a “vanishing twin,” in which the test picks up the DNA of a twin embryo that does not survive after the test is administered. Or it might detect DNA from an earlier fetus that miscarried.

The Illinois Attorney General’s Office is investigating the gender test following a National Public Radio segment on women complaining about inaccuracies. Pregnancystore.com, which exclusively sells the kits, is based in Illinois. Another gender test maker, Paragon Genetics, is in Canada.

Wang and Sherry Bonelli, the owner of the online outlet, vigorously defend their claims.

Said Bonelli: “Historically, ultrasound has an 80 to 90 percent accuracy rate. So 10 to 20 percent are going to be incorrect (in determining the baby’s gender). Acu-Gen is looking at DNA and you can’t make up DNA.”

She said she has personally received 10 to 15 complaints about accuracy from women _ a tiny percentage of the 4,000 who have ordered the test.

Like Rivera, Pamela Gold of New York said she decided to find out the gender of her first baby with a kit because it sounded like fun. The test, conducted in the seventh week of pregnancy, said she was having a boy. But ultrasounds kept indicating a girl. She got a definitive answer when she had amniocentesis to rule out a potential problem with the baby. Gold said the baby is fine, and it is a girl.

Women, Gold said, should “think about the implications” before taking the test. It’s not just, `Oh great, I found out it’s a boy or girl.’ It may raise questions.”

Gold sent Wang another blood sample to test. She wants the company to honor its double-your-money-back guarantee if the test proves inaccurate. The kit costs $25, and the test fee is $250, according to Bonelli’s Web site.

Rivera did not heed Wang’s advice to have genetic testing because her obstetrician felt her ultrasounds (the latest was performed Oct. 25) do not indicate a problem.

(Peggy O’Crowley covers family issues for The Star-Ledger of Newark, N.J.)

KRE/PH END OCROWLEY