turf war: Gene Testing Questioned by Regulators

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Gene Testing Questioned by Regulators

By ANDREW POLLACK

June 26, 2008

http://www.nytimes.com/2008/06/26/business/26gene.html

Regulators are cracking down on companies that sell genetic tests

directly to consumers, threatening to crimp the growth of one of the

hottest sectors of the biotechnology industry.

The California Department of Public Health sent " cease and desist "

letters to 13 genetic testing companies two weeks ago, telling them they

could not solicit business from state residents. The companies include

the early leaders in the field --- 23andMe, Navigenics and deCode

Genetics --- which are trying to carve out a new business of offering

personal genetic information for use in health and lifestyle planning.

The California action follows efforts by New York State, which has sent

letters to 31 genetic testing companies since November, saying they need

licenses to solicit DNA specimens from the state's residents.

Pressure is also mounting for the federal government to take more

action. A report in April by a federal advisory committee said there

were significant gaps in the oversight of genetic tests that could lead

to patient harm. The Department of Health and Human Services will hold a

two-day public meeting July 7 and 8 to discuss regulation of personal

genetic information services.

The Federal Trade Commission, meanwhile, has started investigations into

possibly deceptive advertising or marketing of genetic tests, according

to an agency official who spoke at a June 12 meeting convened by Senator

Gordon . The senator, an Oregon Republican, has been prodding

federal agencies to take a stronger stance in overseeing genetic tests

sold to consumers.

Yet the move to regulate the tests is raising many issues. What are the

standards for proving a genetic test is valid? Must a doctor always be

involved in ordering such tests to protect patients, or is that an

attempt by doctors to protect their turf?

Some of the companies say people have a right to know the information in

their genes and to guide their own health care.

" We think your genetic information is a fundamental part of you, " said

Anne Wojcicki, a co-founder of 23andMe. The company, based in Mountain

View, Calif., has attracted attention not only because of its $1,000

genome testing service but because it is partly financed by Google and

because Ms. Wojcicki is married to the Google co-founder Sergey Brin.

Navigenics and 23andMe say they are not offering medical testing, but

rather personal genetic information services. Using a saliva sample,

they scan a person's genome at multiple points looking for variations

that might indicate a person is at a higher than normal risk for certain

diseases.

" This doesn't say you have a disease, " said Mari Baker, the chief

executive of Navigenics, which is based in Redwood Shores, Calif., and

whose service costs $2,500. " It says you carry a genetic predisposition

for the disease and should talk with a health care professional. "

But not everyone agrees with that rationale.

" We think if you're telling people you have increased risk of adverse

health effects, that's medical advice, " said Ann Willey, director of the

office of laboratory policy and planning at the New York State

Department of Health.

Genetic tests that are developed by clinical laboratories generally do

not require approval by the Food and Drug Administration before they can

be marketed.

The laboratories themselves are regulated by the Centers for Medicare

and Medicaid Services. Such regulation is meant to ensure that

laboratories are proficient and that the tests are " analytically valid. "

That means that if a test purports to detect a particular genetic

variation, it does so reliably.

But critics say such regulation does not assure that tests are

" clinically valid " --- that having a particular genetic variation

actually means a person has a disease or is at risk for one. Critics

also say many tests now being sold to consumers are not backed by

adequate scientific studies.

The California letters, sent on June 9 and 10, said the companies needed

to have state licenses as clinical laboratories. In addition, they said,

genetic tests could be ordered only by a doctor, not by consumers.

" We started this week by no longer tolerating direct-to-consumer genetic

testing in California, " L. Nickel, chief of laboratory field

services for the state health department, said during a June 13 meeting

of a state advisory committee on clinical laboratories.

Lea , a spokeswoman for the health department, said the letters

were sent in response to consumer complaints about the cost and accuracy

of the tests.

Most of the attention so far has focused on Navigenics and 23andMe

because of their high profiles and the fact that they acknowledged

getting the state's letters. The identities of most of the other

recipients were unknown until Tuesday, when the state health department

posted all 13 letters on its Web site.

The other recipients include Knome, which is offering to do a complete

sequence of a person's genome for $350,000.

Also on the list were a few companies that give diet advice based on a

person's genes (and in some cases also sell dietary supplements). There

were also some companies that offer genetic tests for single conditions,

like the risk of baldness or Alzheimer's disease.

The companies had until this Monday or Tuesday to respond to the agency,

which will now review the responses.

At least one company that received a letter, Sciona, has stopped

offering its gene testing and related diet advice to residents of

California and New York. DeCode's Web site indicates that certain

calculations of disease risk will not be available to residents of New

York, California and several other states.

But Navigenics and 23andMe say they believe they comply with the

regulations and are continuing to accept samples from Californians.

Navigenics has stopped accepting orders from New York while its

laboratory seeks a state license. But 23andMe said it continues to

accept orders from New York.

Both companies say they do not need a license from California because

the genome scans are actually performed by outside laboratories that do

have state licenses.

Navigenics said its tests are ordered by a physician because a doctor on

contract to the company reviews customer orders before the specimens are

passed to the testing laboratory.

But Kathy Hudson, director of the Genetics and Public Policy Center at

s Hopkins University, said that " some doc on the payroll at Genes R

Us " is not the same as a personal physician.

Dr. Hudson said it was " not surprising that the states are stepping in,

in an effort to protect consumers, because there has been a total

absence of federal leadership. " She said that if the federal government

assured tests were valid, " paternalistic " state laws could be relaxed

" to account for smart, savvy consumers " intent on playing a greater role

in their own health care.

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