July 28, 2006

Home DNA tests misleading: US congress

By Maggie Fox

WASHINGTON (Reuters) - Home DNA kits that claim to inform
people of their risk of certain diseases, ranging from cancer
to osteoporosis, offer little real guidance and are often
misleading, according to a Congressional report released on

An investigation into 14 companies that sell the tests
showed many gave meaningless information and some tried to sell
consumers expensive "customized" supplements that were little
different from grocery store vitamin pills.

The Food and Drug Administration and the Centers for
Medicare and Medicaid Services said they were investigating the
companies and checking to see whether more oversight was

"Clearly consumers are being misled and exploited by this
modern day snake oil and I am shocked to learn how little the
federal government is doing to help consumers make informed
decisions about the legitimacy of these tests," said Oregon
Republican senator Gordon Smith.

Smith, who is chairman of the Senate Special Committee on
Aging, held a hearing to release a report from the Government
Accountability Office on the home test products.

Often called nutrigenetic tests, they usually involve a
customer taking a swab from inside the cheek and sending it to
the lab for analysis. The GAO took samples from two people and
sent them to 14 different labs under fictitious names.

The GAO report found that the tests were not clinically
valid and that companies mislead consumers by making unproven
and ambiguous health-related predictions.


"Demand for this type of service appears to be on the rise;
one company estimates that it has sold over 35,000 nutrigenetic
tests to consumers since it began selling the tests in the
United States in 2003," the GAO's Gregory Kutz told the

Officials from the Food and Drug Administration and from
the Centers for Medicare and Medicaid Services agreed with the
GAO's findings that the tests were largely meaningless and said
they were investigating.

Kathy Hudson, Director of the Genetics and Public Policy
Center at Johns Hopkins University in Washington, said the FDA
had not been clear on what its role should be in regulating the

"The current regulatory environment fails to ensure the
quality either of the laboratories performing genetic testing
or of the tests they are offering," Hudson told the hearing.

She recommended that the Center for Medicare and Medicaid
Services enforce regulations that might affect the labs and
make new rules under the 1988 Clinical Laboratory Improvement
Amendments, under which laboratory tests are regulated.

Officials of some of the companies investigated by GAO
defended their products and services.

"I support your efforts here and I believe we need to have
more regulation," said Howard Coleman, chief executive officer
of Genelex Corporation in Seattle, Washington.

But when asked why the companies returned 14 different
profiles for DNA samples taken from just two people, Coleman
answered: "Senator Smith, I would like to see those reports and
go over them...here may be explanations for this."