Sixteen US women have filed a lawsuit against the makers of a home-testing kit that promises to determine the sex of an embryo as early as five weeks after conception. In a suit filed in the US District Court in Boston, the women claim that the test got the gender of their babies wrong, causing them confusion and distress. They also say that Acu-Gen Biolab, the company that makes the $275 kit, is refusing to honour its double money back guarantee.
The Baby Gender Mentor home testing kit was launched last summer, marketed through the website Preganancystore.com as being for the type of woman 'who can't wait to open their Christmas presents'. Customers are asked to send a finger-prick blood sample to Acu-Gen's lab in Lowell, Massachusetts for testing. The lab detects and analyses tiny amounts of fetal DNA floating in the mother's blood, and checks for the presence of Y chromosomes. If Y chromosome DNA is found, then the baby is a boy, if not, then it is a girl - a test that the company claims is 99.9 per cent accurate.
The kit initially sparked controversy, with some ethicists expressing concern that it might be used for sex selection purposes. Then, a few months after it was launched, some pregnant mothers complained that the test results conflicted with the sex of their babies as determined by ultrasound scans. At the time, Acu-Gen said the test was accurate, and claimed that ultrasound scans are notoriously inaccurate at determining gender. But further questions were raised over the test, when babies of the opposite gender to that predicted were born.
Dozens more women may be named in the suit, as the judge has been asked to allow all women who have bought the test since 1 January 2004 to be represented. 'When you're essentially guaranteeing a test is 99 per cent accurate, people rely on you, and you can't make those sorts of representations and get away with it', said Barry Gainey, a lawyer for the plaintiffs. Women who asked for a refund were asked by the company to provide blood samples and fingerprints of their newborns, but even then only one was given her money back. Acu-Gen allegedly told some of the women who complained of conflicting results that their babies could have birth defects - advice that lead to many women undergoing unnecessary amniocentesis procedures.