When the Baby Gender Mentor hit the market last year, expectant parents thought it meant they no longer had to wait until about mid-pregnancy to find out the gender of their baby.
Using just a few drops of the mother's blood, Acu-Gen Biolab of Lowell, Mass., said the kit could detect the gender of the fetus with 99.9 percent accuracy -- and as early as five weeks into pregnancy. The test costs $275 and comes with a 200 percent money-back guarantee.
But now parents are raising concerns about the test -- on Monday 40 people who purchased the kit filed a class-action lawsuit in Massachusetts claiming incorrect test results.
In the suit, the claimants said they relied on the company's promise to refund the fee if their tests weren't accurate, but when they tried to get their money back, the company refused to provide a refund and instead changed the terms of the refund policy, acccording to the lawsuit.
Acu-Gen, meanwhile, maintains that the product works. President C.N. Wang told "World News Tonight" on Monday that the suit is "totally bogus."
According to the lawsuit, at the time that the products were purchased, a customer had to do two things in order to get a refund: wait until the baby was born and provide a valid copy of the child's birth certificate.
However, when the women whose tests turned out to be incorrect tried to get their 200 percent refund, Acu-Gen changed the rules, the parents say. Instead, the company insisted that the women had to deliver a live baby, provide an original birth certificate, provide a blood sample and fingerprints from their baby and more. In some cases, customers were told that they were not entitled to a refund because they were carrying a "vanishing twin," according to Gainey & McKenna, the New Jersey-based law firm representing the case.
Acu-Gen's kit claims to detect both male-fetus- and female-fetus-specific chromosomal DNA in the expectant mother's blood sample "with an unprecedented sensitivity and specificity."
However, the company does not provide any research or specific studies.
Right now, the product's exclusive retailer is a Web site called pregnancystore.com, run by CEO Sherry Bonelli. She says on the Web site that the kit is "proprietary patent-pending technology," but does not give further scientific details.
Some scientists said the technology is possible in theory, but expressed doubt about Acu-Gen's claims.
"They claim that they are able to detect either a male or female fetus, yet they clearly indicate that no males should come near the pregnant patient when taking the blood sample -- this is contradictory to their claims," said Dr. Patrick P. Koty, an assistant pediatric professor and director of the Molecular Genetics Laboratory at Wake Forest University School of Medicine. "I would be very skeptical about the validity of this test and would not recommend it until it was validated."
On the other hand, Dr. Charles Lockwood, chairman of obestrics and gynecology at Yale School of Medicine, said that it is possible for fetal DNA to be found in maternal blood as soon as the placenta has developed, and that "five weeks is not impossible."
In fact, scientists are already able to determine the blood type of the fetus, albeit a bit later in pregnancy. The problem, Lockwood said, is with DNA isolation in general. Males have XY chromosones and females have XX chromosones.
"If you identify a Y chromosome, you can make a pretty good guess that it's a male, but for a female it's more difficult," Lockwood said. Also, fetal cells from previous pregnancies can continue to circulate and confuse the results.
Early-detection capabilities also raise complicated ethical issues, such as the potential increase in gender-selective abortions, experts noted.
For example, Lockwood said, "a disproportionate number of female fetuses have been terminated worldwide, and a 2-to-1 male-to-female ratio could lead to social unrest and wars."
In other words, does the ability to buy pink or blue clothing and room decorations early outweigh the potential for selective terminations?
Another important issue to consider is that all pregnancies naturally carry a 20 percent miscarriage rate, said Dr. Henry Klapholz, chairman of obestrics and gynecology at MetroWest Medical Center in Framingham, Mass., and a professor at Harvard Medical School.
"At five weeks, quite frankly, you don't know if a pregnancy is 'good,'" Klapholz said. "It's bad enough to think you're going to have a baby because of a positive pregnancy test. Now couples will imagine a baby, then the gender of baby, then the name of the baby -- this could be potentially more devastating than a miscarriage."
"I always tell my patients, don't plan on a pregnancy until you have a fetal heartbeat; otherwise, the outcome could be terribly disappointing," Klapholz continued." To test so early would be unwise."