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Updated Sunday, March 2, 2008 0:00 am TWN, By KAREN KAPLAN, Los Angeles Times



	A prenatal gender test predicted a daughter for Anissa Iverson of Burbank, Calif., with her son, Zachary, almost 2.(Los Angeles Times photo by Al Seib) Enlarge Photo

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Problems follow early reads on baby’s sex

Italian researchers published a study in 2005 demonstrating that they could correctly identify 98.7 percent of boys and 100 percent of girls by looking for male DNA in maternal blood drawn during the first trimester. But their method required a relatively large blood sample — 10 milliliters — that was processed within a few hours.

The companies, in contrast, require just three to 10 drops of dried blood, which can take days to arrive through the mail. Laura Cremonesi, senior author of the Italian study, said that she doesn’t know anything about the companies’ laboratory procedures and has no idea if their methods would work. Nguyen, of Consumer Genetics, said the Pink or Blue test is more sensitive than the one used in Italy because it looks for a DNA marker that is 100 times bigger.

“There’s more of it, so it’s easier to spot,” Nguyen said. For competitive reasons, she wouldn’t give any specifics about the particular sequence of male DNA that the company searches for.

Acu-Gen’s Web site lists dozens of clinical studies that it says corroborate its approach, though none of them involved the specific DNA sequence that Acu-Gen says it uses in Baby Gender Mentor and none reported accuracy as high as 99.9 percent.

A woman who answered the company’s phone said she was “not interested” in discussing the test’s accuracy. Other calls and e-mails to Acu-Gen were not returned. In court filings, the company denied “any wrongdoing and any liability” in connection with incorrect test results.

Diana W. Bianchi, a medical geneticist at Tufts-New England Medical Center in Boston who worked on the 2004 NIH study, said that little or nothing is known about the companies’ methods.

“There’s no evidence that they’ve undergone any quality assessment,” she said. “As best as I can tell, anybody can set up a virtual shingle and open for business.”

Bianchi added that there is more at stake than just lost money or disappointment.

“As a physician, I’m most concerned not that someone has painted the nursery the wrong color, but what are the medical consequences of someone taking this test?” she said. An incorrect result could lead to “unnecessary amniocentesis and other procedures that carry a risk of miscarriage.”

Plaintiff Anissa Iverson, who works as an office manager at Disney Studios in Burbank, Calif., mourned when she discovered that the baby she expected to be a girl was actually a boy. She already had washed and folded more than US$500 worth of clothes for the daughter, to be named Sydney. When she and her husband realized they would be having a son, they changed the baby’s name to Zachary.

Iverson became pregnant again, this time with a girl. The clothes bought for Sydney came out of storage, but the name could not be resurrected.

“I felt like Sydney had died,” she said. “It was a tainted name.”

Instead, she named her daughter Courtney.

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