Anne Wojcicki, 23andMe at the 2014 BIO International Convention

Anne Wojcicki
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5 Video Views·Jun 8, 2026
Anne Wojcicki, Co-Founder & CEO of 23andMe, discusses how her company has been working with the FDA for approval of her direct to consumer genetic testing.
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AI GeneratedAnn Wojcicki, CEO of 23andMe, discusses the company's efforts to regain FDA approval for returning health results, starting with a test for Bloom syndrome. She emphasizes the importance of consumer participation in medical research to accelerate drug discovery and expresses optimism regarding the current state of the biotechnology market and the future of precision medicine.
I'm Mike Huckman at the BioBuzz Center where I am pleased to welcome Ann Wojcicki who's the
founder and CEO of the DNA testing company 23andMe which as everybody knows has had a significant
setback lately but remains on the path to kind of fulfilling your quest to I guess turn personalized
and precision medicine from a dream into reality. So let's start with that first. You recently had
news regarding establishing the beginning of a path forward with the FDA for approval of your
test for specific types of results. Tell us where things stand. Sure so November 22nd we got a letter
from the FDA asking us to stop returning health results and so after about seven months we
hired significantly. We hired some key leadership and we really started working on what is that key
path forward. How are we going to enable customers to get health results back. So we announced on
Friday that we have submitted to the FDA our first snip test on blooms. That's a rare
disease or condition. It's a rare condition that you can be a carrier for and if both parents are
carriers for and they have a child then their child would have a risk for having it. Mostly Ashkenazi
Jews. Exactly mostly Ashkenazi Jews. So we submitted on that and really just to get you know
work with the FDA to get the platform approved. So how is it that we can actually just set up a pathway
so that in the future when we have the say even whole genome sequencing that there's a whole a
scalable pathway where we'll be able to actually return lots of health results. So Ms. Wojcicki
what are the next steps with the FDA? What do you anticipate the timeline will be and how confident
are you that it'll get you to where you need and want to go? I mean these are all great questions.
I'm one of those people who's eternally optimistic so I really believe that we've had a great working
relationship with the FDA. They have actually been incredibly responsive with us and
and it's clear that they are looking for a path to make direct-to-consumer genetic testing
something that could that can materialize. So based on you know all the various 510k laws
there's 90 days for them to respond and we are looking forward to getting that response and that
and and seeing what can what can happen. As a former media guy turned communicator now I thought
it was rather noteworthy that you decided to break this news as it were on your own corporate blog
as opposed to doing the stereotypical traditional thing which would be to blast out a press release
to everybody and their sister. What was the strategy behind that? Yeah so a little bit of
history of the company you know we're a startup and so we've always been under a budget and we've
been cheap and so part of part of the benefit I think of being a startup and not having being
cash constrained is that you have to be innovative and you know so putting out a press release
potentially costs money and and it's potentially sort of more of the old school and part of a lot
of our customers are online and so it's an effective way for us to actually communicate
with our customers and and with the broad media by just putting out information on our sites and
then it also drives people to us so so you know I think the origins of it probably in the early
days were sort of my budgetary constraints right I just tended to be cheap and and I think in in
now when we make a decision we decide we make an actual conscious decision about what information
actually needs to go through the whole route and what information actually is is do we just put on
our blog? Very smart I think there's a lot of talk here at bio this year about increasing the
efficiency expediting clinical trials and research development in this industry what role if you're
successful could 23andMe and companies like yours other diagnostic and testing companies
play in helping that along? Yeah so luckily I was just I was at a in DC yesterday and I was at
chairman Upton who oversees the the energy and commerce committee he actually had a really
phenomenal roundtable on focus on 21st century cures. He has a bill I think Upton and to get
due to to foster that. Right so so Upton and to get actually fostered this roundtable discussion
and I would actually say it's all about how are we going to innovate and how are we going to bring
technology together with health care to actually really dramatically innovate and make cures come
faster and and one of the things to me that was so central in the theme that that came up yesterday
was that the consumer needs to be part of it and that in part by just having researchers and then
having sort of institutions and not really engaging you we're missing out on a critical
part and one of the things I think that's core that 23andMe is that we want to transform you
from a human subject into someone who's actively participating in research where I communicate back
with you what the results are I ask you ongoing questions I'm constantly engaged with you because
if you have a certain condition you want to know the results and you probably want not just me
looking at it but you want all the researchers in the world looking at it and you want to hear if
they have more questions for you you'd probably be interested in in answering those questions
so how can we actually engage you really with the entire research world and I think that is going to
dramatically accelerate the pace of discovery because such a significant part of research today
is just on finding the individuals to enroll in the study. And finally there's a lot of debate
and discussion here about the capital markets. Is the IPO window still open? Is it reopening? Is it
closing? Is it closed? Because of your pedigree you were a biotechnology investor on Wall Street
before you started 23andMe what's your assessment right now of the market? Yeah I have I have the
luxury of being a little bit more out of it so I wouldn't say that I I know too well but just based
on the the information that I get and sort of the interest that I get from VCs and the interest that
I get and even you know on people wanting to buy stock and in the secondary markets and such
is that there's definitely the biotech market is hot and I do think that there's also
been a number of really promising successes that have shown that there are going to be novel ways
of looking and it reminds me a little bit when I was investing in the late 90s and it was right
around the time that the whole genome was getting going and there was this palpable sense of
enthusiasm and I see that with now like there is you know there's these long cycles where it takes
a while for a technology to really become into fruition and I think genetics really has that
potential of transforming the drug discovery process so I'm I feel a sense of enthusiasm
and I get the sense from my biotech peers that there's real enthusiasm. With the caveat that as
you said before you're an eternal optimist as well. I am an eternal optimist I wouldn't be in this
industry I'd be doing other things if I wasn't so optimistic but I really believe that at some
point in our life we're going to see tremendous progress in health care and I think we'll look
back and say wow we really did things in a strange way before. Don't we all hope so. Anne Wojcicki
the CEO and founder of 23andMe thanks again for joining us here at the BioBuzz Center.
