UPDATE: Walgreen Won't Offer Genetic Test Until FDA Approval Status Clear
Walgreen Co. (WAG) said it won't sell an over-the-counter
genetic test to consumers until the company that makes the test
works out any regulatory issues with the U.S. Food and Drug
Earlier Wednesday, the FDA said it had contacted Pathway
Genomics about its plans to sell a test designed to predict a
person's risk of developing diseases or how they might respond to
certain drugs. The company, a closely-held firm based in San Diego,
announced plans this week to sell its Insight Saliva Collection Kit
through 6,000 Walgreen stores for between $20 to $30 a test.
In a statement, Michael Polzin, a Walgreen spokesman said, "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."
In a letter to Pathway, the FDA said "it has been unable to
identify any Food and Drug Administration clearance or approval
number for the Genetic Health Report," suggesting the agency
believes the test should be agency approved.
In a statement Wednesday, Pathway said, "we respect and
understand Walgreen's decision and we are communicating with the
FDA about the Pathway Genomics Insight collection kit."
In an interview on Tuesday, Ed MacBean, Pathway's vice president
for product development, said the company believes the test falls
under FDA regulations that don't require the agency to approve the
test before it's marketed. He said the company's laboratories have
been certified by the federal government under a program run by the
Centers for Medicare and Medicaid.
MacBean said the company has spoken with the FDA and wants to
ensure it is "compliant with all the rules."
However, the agency also said if Pathway didn't think it needed
to obtain FDA "clearance or approval for the Genetic Health Report"
it should provide the agency the basis for that determination. The
letter was dated May 10 and released by the agency Wednesday.
The test uses a person's saliva to analyze each person's
individual genetic profile. The product could also be used in
pre-pregnancy planning to predict the risk of 37 genetic diseases
caused by recessive genes that might be passed to a child from
parents, according to the company that makes the test. Saliva
collected from the test would be sent to the company and analyzed
for an additional price of $79 to $249, depending on what
information a person requests. The information would be downloaded
from a secure company website.
Pathway, which was formed last year, has been selling a similar
test through its website for about $400.
-By Jennifer Corbett Dooren, Dow Jones Newswires; (202)