2Amid the tumult of the delivery room, Rohit and Geeta Jain were calm about one thing: Their new baby was sure to be a boy.
Six months earlier, the Jains had spent more than $300 for a test that screened a minute quantity of Geeta's blood for traces of male DNA. The testing company said it was 95% accurate in determining the sex of a baby, even as early as the eighth week of pregnancy.
After six hours in the delivery room, Rohit gaped as his wife gave birth to a daughter.
"There's only two choices -- either it's a boy or a girl," said Rohit, 35, a computer scientist in the Vancouver, Canada, suburb of Surrey. "I couldn't fathom how it could be wrong."
Like scores of other expectant parents, the Jains had stumbled into a corner of the booming genomics industry and discovered that the claims of some genetic entrepreneurs have gone beyond what science can provide.
Marketing directly to consumers, the new crop of companies has jumped into a realm of dubious science, mining DNA to offer information on ethnic heritage, long-lost relatives, personalized dieting plans -- even the sports for which one is best suited.
The tests are loosely based on legitimate scientific research, much of which has been funded by the National Institutes of Health, among others. But often, the companies' claims of accuracy have not been backed up by independent laboratory analysis.
Thousands of consumers have bought tests -- and analysts say the number will only grow as entrepreneurs find more ways to market the mysteries of the human genome.
The Federal Trade Commission, which protects consumers from false and misleading advertising, has warned buyers to be skeptical of at-home genetic tests, which are now unregulated.
In most cases, customers have no way of judging if their test results are accurate. But if a prenatal gender test is wrong, parents will surely find out.
The tests, scientists say, are the latest incarnation of old wives' tales about salty food cravings, hairy legs and belly shapes denoting the sex of the impending baby. This time, the predictions are being sold with the patina of cutting-edge genetic technology.
A host of companies, such as Acu-Gen Biolab Inc. of Lowell, Mass., and Consumer Genetics Inc. of Sunnyvale, Calif., have been selling the tests for $249 and up. Critics say they are banking on most disgruntled parents being too happy -- or too busy -- with their new child to file for a refund.
The consequences aren't merely financial.
"I wouldn't have had an abortion, but there are women out there who experience really big disappointment," said Jolene Sodano, a stay-at-home mother in Nazareth, Pa., whose daughter was mistakenly identified as a boy. "They really want to give their husbands the little boy they want, or a little girl, and they will abort based on these results."
More than 100 women have filed a lawsuit against Acu-Gen and its owner, Chang-ning Wang, that is pending in federal court. At least one customer has been questioned by the FBI. Wang has repeatedly declined to discuss the scientific validity of the test.
"It made me very angry at myself for believing this gibberish," said Mandana Kouroshnia, a Redlands dentist who joined the suit after her test incorrectly predicted a boy. "I made a fool out of myself."
Ripe for exploitation
The rise of direct-to-consumer genetic tests has come with surprising speed after the decoding of the human genome in 2000. Today, about 1,400 different types are being sold to consumers.
In the past, virtually all testing was done in medical laboratories for diagnostic purposes, such as searching for the mutations in the BRCA1 gene that are related to breast cancer.
But the development of faster and cheaper machines to sequence specific genes quickly gave entrepreneurs an opportunity.
Any trivial genetic quirk can be ripe for exploitation. Consumer Genetics, for example, offers a $139 test called CaffeineGEN that screens for a DNA variant that causes caffeine to be metabolized slowly and is associated with an increased risk of miscarriages and nonfatal heart attacks. The company is also developing a test for a gene variant that might allow people to lower their cholesterol levels through moderate wine consumption.
Both tests are based on documented genetic aberrations, but there has been no proof that they can accurately predict health outcomes.
The gender tests got off to a splashy start in June 2005, when Acu-Gen's Baby Gender Mentor was featured on NBC's "Today" show. Holly Osburn, then seven weeks pregnant, went on the morning program to find out whether her third baby would be another girl or her first boy. On live TV, she appeared to force a smile after being told to expect a daughter.
The company's website said its $275 test was able to detect fetal genetic material as early as five weeks after conception with up to 99.9% accuracy.