(Adds comment from Australian regulator paragraphs 14-15,
By Christina Farr
SAN FRANCISCO May 6 Genetics startup 23andme is
forging ahead with plans to sell its full-fledged test kit, but
will focus on overseas markets after facing regulatory hurdles
at home from the U.S. Food and Drug Administration, a person
with knowledge of the matter said.
The Google Inc -backed firm is targeting
English-speaking markets, with Australia, Canada and Britain the
most likely contenders, the person said, declining to be named
as they were not authorized to speak to the media.
A spokesperson said the company was considering expanding
abroad, but declined to give details. "We are in the process of
evaluating international opportunities," said 23andme
spokesperson Catherine Afarian
Last year, 23andme agreed to stop selling its $99 DNA test
in the United States until it obtained marketing authorization
from the FDA. In a public warning letter, the FDA said it feared
false positive or false negative results from the genetic test
could prompt patients to take "morbidity inducing" actions, like
The FDA may take years to decide on the gene testing kit. In
the meantime, 23andMe aims to offer partial or full
genetic-testing services outside of the United States by the end
of the year, the source said.
23andme currently sells an abridged version of its test in
over a dozen countries, which excludes analysis about a person's
health risks. This test includes raw health and ancestral
information, such as a person's ethnic heritage.
The full test analyzes probabilities that a person may come
down with a certain disease or condition, such as diabetes.
Formed in 2006 by Anne Wojcicki, wife of Google co-founder
Sergey Brin, 23andme previously said it could deliver insights
about people's genetic predispositions toward 254 diseases and
conditions, all from a swab of saliva.
Wojcicki, the company's chief executive, worked as a health
care investor and analyst for over a decade before starting
23andme. In a company blog post, Wojcicki stressed that she
"stands behind the data" and would work in concert with the FDA
to "lay the groundwork" for regulatory approval for however long
"In the meantime, if a route to faster approval exists for
23andme, it's smart to consider it," said Patricia Zettler,
former associate chief counsel with the FDA who now serves as a
fellow at Stanford University's center for Law and the
In fact, if the company doesn't start selling its test
abroad, she added, "it might be more difficult to get the data
to support authorization in the U.S."
POTENTIAL PROBLEMS ABROAD
Bradley Merrill Thompson, a Washington D.C.-based attorney
with Epstein Becker Green, said Canada is a logical choice for
health entrepreneurs because of its affluent health system and
clear regulatory guidelines.
"But in most countries, regulators will be concerned about
whether 23andme's medical predictions would trigger actions,"
said Merrill Thompson, who counsels clients on FDA regulatory
Australia's Therapeutic Goods Administration (TGA), the
regulatory agency for medical drugs and devices, said genetic
tests like 23andme's could not legally be supplied in Australia,
but could be imported for personal use.
"It is strongly recommended that those people wishing to
undertake testing of this nature talk to their GPs and utilize
tests that have been fully evaluated and registered," a TGA
spokeswoman said, urging caution on evaluating the test results.
Legal experts say 23andme may run into the same regulatory
hurdles abroad as it has in the United States.
The European Parliament recently proposed regulations that
would restrict companies like 23andme from carrying out genetic
tests without "informed consent" from a medical professional.
"A movement is underway in Europe to target genetic testing
services," said Eric Vollebregt, an Amsterdam-based intellectual
property lawyer with Axon Lawyers who has spoken in support of
23andme and against the amendment.
Another layer of complexity is the question of whether
23andme should be regulated as a medical device, which comes
with more stringent requirements. The FDA regards it as such,
but regulators abroad might classify it as a health service.
Bioethics experts like Duke University's Nita Farahany, have
argued that 23andme poses no more risk to patients than a common
"Just because information can help in the diagnosis of a
medical condition does not mean that it should be considered a
'medical device' subject to FDA jurisdiction," Farahany wrote on
a Duke University news site.
(Additional reporting by Byron Kaye in SYDNEY; Editing by
Bernard Orr and Miral Fahmy)