| SAN FRANCISCO
SAN FRANCISCO May 6 Home genetics startup
23andme is forging ahead with plans to sell its full-fledged
test kit - just not in the United States.
The Google Inc -backed firm is moving to
English-speaking markets abroad after facing hurdles from the
U.S. Food and Drug Administration, according to one person with
knowledge of its plans.
Late last year, the company agreed to stop selling its $99
DNA test 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 23andme's genetic test
could prompt patients to take "morbidity inducing" actions, like
Now, 23andme has formed a team internally to explore the
path to approval overseas, the person with knowledge of the
company, who asked not to be named, told Reuters.
"We are in the process of evaluating international
opportunities," said company spokesperson Catherine Afarian
without sharing specifics.
While it awaits the agency's approval, a process that could
take years, 23andMe aims to offer partial or full
genetic-testing services in one or more countries outside of the
United States by the end of the year, with likely contenders
including Canada, Australia and the United Kingdom, the source
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 does include 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 that takes.
"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."
Bradley Merrill Thompson, a Washington D.C.-based attorney
with Epstein Becker Green, said Canada is a logical choice for
health entrepreneurs because it boasts an 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
issues. According to Thompson, medical device regulation differs
country-by-country and is highly dependent on the claims a
company makes about its product.
Going international may seem like a practical strategy, but
23andme may run into the same concerns as it has back home,
legal experts say.
Europe may grow less receptive to a company like 23andme in
the near future, said Eric Vollebregt, an Amsterdam-based
intellectual property lawyer with Axon Lawyers. The European
Parliament recently proposed regulations that would restrict
companies like 23andme from carrying out genetic tests without
"informed consent," from a medical professional.
That would prevent 23andme from providing health information
direct to consumers' homes.
"A movement is underway in Europe to target genetic testing
services," said Vollebregt, 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.
(Editing by Bernard Orr)