* Agency says wants proof of Pathway test approval
* Test was to be sold in Walgreen drug stores this week
(Recasts, adds Walgreen comments)
By Julie Steenhuysen
CHICAGO, May 12 Walgreen, the nation's biggest
pharmacy chain, says it will delay plans to sell genetic
testing kits after the U.S. Food and Drug Administration
demanded proof the kits have regulatory clearance or some
reason why they should be sold without the agency's blessing.
The FDA on Wednesday released a May 10 letter to privately
held Pathway Genomics Corp over its saliva genetic test saying
the agency was "unable to identify" FDA approval for Pathway's
Genetic Health Report.
U.S. pharmacy chain Walgreen WAG.N said on Tuesday it
planned to start selling Pathway's genetic testing kits to help
people assess their risk for inherited diseases, making it the
first U.S. drug store chain to put such tests in local
But the company has now decided to put the kits on hold.
"In light of the FDA contacting Pathway Genomics about its
genetic test kit and anticipated ongoing discussions between
the two parties, we've elected not to move forward with
offering the Pathway product to our customers until we have
further clarity on this matter," Jim Cohn, a Walgreen
spokesman, said in an e-mail on Wednesday.
Pathway has said its personal genetic testing kit, the
Pathway Genomics Insight Saliva Collection Kit, can be sold
without FDA clearance because it is not intended for use in
diagnosis, treatment or for the mitigation or cure of a disease
-- qualities that would make it an in vitro medical device,
which the FDA does regulate.
Pathway's test contains a small saliva collection kit,
instructions and a postage-paid envelope customers can use to
send their sample back to the Pathway lab.
Then, consumers go on the company's website,
www.pathway.com, to order a customized report about their
genetic make-up, with prices ranging from $79 to $249.
The reports give consumers genetic information on more than
70 health conditions, including a person's response to some
prescription drugs, their propensity for diseases and whether
they could pass any inherited diseases on to their children.
Consumers are meant to use this information to modify their
"The Genetic Health Report appears to meet the definition of
a device as that term is defined in section 201(h) of the
Federal Food Drug and Cosmetic Act," according to the letter
signed by James Woods, deputy director of patient safety and
product quality in the FDA's Office of In Vitro Diagnostic
Device Evaluation and Safety.
NEED FOR COUNSELING
Several groups have raised concerns over the sale of such
test kits directly to consumers, noting such tests offer
incomplete information and any results about disease risk,
especially for incurable diseases such as Huntington's or
Parkinson's, should only be done with counseling that clearly
explains the limitations of genetic testing.
The American Clinical Laboratory Association on Wednesday
urged consumers to seek the guidance of their doctor or other
health care provider before using direct-to-consumer genetic
tests to ensure proper understanding of the results and
"Many direct-to-consumer genetic testing companies are not
testing individuals for disease -- they are testing for the
propensity of developing disease conditions," Alan Mertz,
president of ACLA, said in a statement.
"Although such testing can offer useful information, it
requires clear and personal communication between patients and
healthcare providers so that steps can be taken to limit the
likelihood of developing disease and control its effects."
Scientists have only a limited understanding of genes that
contribute to complex diseases, such as heart disease or
diabetes, and several studies have shown that using genetic
information is much less effective than factors such as family
history at predicting a person's risk of developing these
(Additional reporting by Susan Heavey in Washington and
Jessica Wohl in Chicago; editing by Cynthia Osterman and Todd