Collecting DNA samples at home raises concerns

Many professionals are
concerned about how people will react to unfavorable results.

SAN FRANCISCO CHRONICLE

SAN FRANCISCO — Want to find out your baby’s gender? Or who the father is? What about whether you possess a gene that makes you more likely to get cancer?

These are all tests that now can be taken in the comfort of your own home.

Consumer Genetics Inc., a Sunnyvale, Calif., company formed last year, is one of a growing number of companies capitalizing on advances in DNA testing that make it possible for consumers to collect a genetic sample at home and send it back to the company for testing. Costs can range from a few hundred dollars to more than $1,000.

Last week, Consumer Genetics added paternity testing to its growing suite of DNA tests, which includes the “Pink or Blue” test, designed to reveal a baby’s gender by the seventh week of pregnancy.

About the test

Consumer Genetics’ paternity test, which is not the only home paternity product on the market, requires a cheek swab from the baby and the possible father. But the test also allows mothers to test their baby’s paternity without the suspected father’s knowledge.

“You can use chewed gum or a shirt the father may have sweated on,” said Cherylle Wilson, product manager at Consumer Genetics, adding that such “discreet” testing is not valid in court.

“The mother can also take a hair sample from a hair brush and send it to us without the father knowing.”

While this brave new world of consumer genetic testing may offer convenience and privacy, it’s largely unregulated and quality may vary widely.

Other concerns

Ethicists and medical professionals are also concerned about how patients may react to undesirable results received at home or whether a mother would seek an abortion if her child is not the gender she or her partner wants.

Those concerns haven’t prevented the industry from tackling serious health issues, though. More companies are offering home tests that indicate an individual’s propensity for serious diseases, such as breast and ovarian cancer, based on the presence of a genetic mutation. These tests raise concerns about how the consumer receives this potentially devastating information.

“What we’re talking about here is an increasing availability of medical technology for consumers,” said Jesse Reynolds, policy analyst at the Center for Genetics and Society, an Oakland, Calif., nonprofit policy and advocacy organization.

“The upside of it is that the individual is empowered. But, at the same time, that can be ... challenging, particularly when what’s at stake is powerful information such as possession of a gene that’s related to a fatal disease.”

Paternity testing — especially if the results are inaccurate — could also create emotional and legal havoc, Reynolds said. “It could be devastating. This could alter children’s and parents’ perspective of each other for decades,” he said.

Consumer Genetics says its paternity test yields probabilities of 100 percent for exclusions and has an accuracy rate greater than 99 percent for inclusions. Standard testing costs $245, but the company charges $645 for discreet testing — meaning the father is not aware of the test — because of the added complexity.

Legal issues

These tricky situations can lead to legal action. A Massachusetts company is facing a class-action lawsuit for reportedly providing false gender results to expectant mothers. More than 100 women from all over the country are suing Acu-Gen Biolab Inc., the maker of a genetic test that the company says will detect the baby’s gender as early as six weeks, for causing distress by providing inaccurate results.

The federal government is starting to address growing concerns over direct-to-consumer testing. Earlier this year, Sens. Edward Kennedy, D-Mass., and Gordon Smith, R-Ore., introduced legislation that would require makers of direct-to-consumer genetic tests to prove to the Food and Drug Administration that their tests are accurate and properly performed.

In the absence of such requirements, experts advise buyers to beware.

“Right now, we don’t have anyone minding the store,” said Kathy Hudson, director of the Genetics and Public Policy Center at Johns Hopkins University.