By Aaron Krol
May 19, 2014 | Starting
in 2006, the U.S. experienced its first wave of market enthusiasm for genetic
health services. In the space of two years, several major players – Navigenics,
23andMe, Pathway Genomics, and deCODE genetics – launched products offering to
take customers’ DNA samples and turn them into reports on common disease risks.
This rush to market has more or less fizzled out now, with every one of these
companies either voluntarily withdrawing from the direct-to-consumer model, or forced out of the
health space by the FDA.
But it’s beginning to look like 2014 will mark a second wave
for genetic health. Bio-IT World has
already covered the entrances of Coriell Life
Sciences and BaseHealth
into the field. Now another entrant, LifeMap Solutions, has dipped its toe in
the water with a quiet launch and hints about its service to
“Obviously, there are a few players in this growing space,
and I think in the next few years we will see explosive and chaotic growth,” says
Corey Bridges, the CEO of the new company. “It’s a unique time for
opportunities and risks.”
Bridges has formerly served as a key business developer for
Netscape, Netflix, and Zone Labs during those companies’ public launches. He
describes himself as being in the “show, don’t tell” camp, and is saying as
little as possible about LifeMap Solutions’ service in advance of a beta test
later this year and an expected public release in 2015. Still, LifeMap
Solutions, as a division of the larger BioTime, Inc., faces certain mandatory
disclosures, and a few reasons have already emerged to keep an eye on the
company: most notably, its decision to go mobile, and the involvement of
renowned systems biologist Eric Schadt.
The Second Wave
The new generation of genetic health companies is sharply
distinct from the 2006-2008 crop. On the one hand, they are more cautious about
dispensing health advice to users, looking for firm regulatory guidance and the
input of health professionals. Both Coriell Life Sciences and BaseHealth are
calling on physicians to act as intermediaries and interpreters, helping users
understand the context of their genetic risks and what behaviors might be
appropriate to improve their health.
LifeMap Solutions has not stated that physicians will be
directly involved in their service, but the idea is clearly on the executive
team’s minds. “Our appraisal is that, in terms of recognizing the need, and consumer
demand for a product, it’s probably greater in the physician community than in
the public right now,” says BioTime CEO Michael West, who joined Bridges in
speaking to Bio-IT World about his
company’s new subsidiary. “The public doesn’t fully understand the information
that can be gleaned from either a SNP analysis or whole genome, but physicians
are seeing all these papers popping up.”
“You certainly don’t want to be making a product that makes
unwarranted predictive or diagnostic claims,” he adds, acknowledging that
LifeMap Solutions is already in touch with the FDA about its product.
Yet despite their abundance of caution, the younger genetic
health providers also in many ways have broader ambitions than their
predecessors. Both Coriell and BaseHealth have built systems capable of storing
customers’ whole genomes, rather than just targeted
genotypes – and through a partnership with the Icahn Institute for Genomics and
Multiscale Biology at Mt. Sinai School of Medicine, one of the country’s major
powerhouses of whole genome sequencing, it seems likely that LifeMap Solutions
will do the same.
On a more basic level, the focus is increasingly on genomics as
just one among many important health variables. BaseHealth is bringing on board
data from patients’ lifestyles and clinical
histories, to place genetic risks in a meaningful context and better
personalize its service. LifeMap Solutions plans to do the same, and will have
the advantage of interfacing with mobile devices, which suggests the
possibility of using wearable devices as an added source of data.
“A platform like the one we’re currently building needs to
have a somewhat modular architecture, so that new data sources can be added as
they make sense.” says Bridges. “We definitely will have a platform that’s
architected to have a wide range of inputs… There’s a chance to get an
unprecedentedly full look at somebody’s health.”
Of course, the genetic element remains a major selling
point. The depth of knowledge needed to really plumb the genome for health
information means that the newer genetic health companies tend not to be fully
independent startups, but closely associated with existing knowledge bases.
Coriell Life Sciences is a commercial spin-off of the Coriell
Personalized Medicine Collaborative, while BaseHealth relies on a
partnership with Illumina, which maintains the world’s largest curated genomic
database through its subsidiary NextBio. LifeMap Solutions, too, draws on the resources of its parent company,
and in particular of BioTime subsidiary LifeMap Sciences, whose GeneCards and
MalaCards products catalogue information on the genetic basis of nearly 20,000
human disorders. “It’s definitely appropriate to say we will be leveraging
expertise and content from LifeMap Sciences,” says Bridges.
plummeting costs of sequencing the genome, and the rapid rise of other
digitized medical data, we recognized that we had a good foundation [at
BioTime] to build a leading service and product to manage all that data,” adds
West. “Not just for researchers, but for the public in general.”
Low Profile Company, High
For many observers, however, the real buzz around the soft
launch of LifeMap Solutions will be its close partnership with the Icahn
Institute. This is the home of Dr. Eric Schadt, who has attracted a reputation
for shaking up fundamental ideas about biology and disease.
Schadt’s guiding passion is for making human biology messier
and more holistic, insisting that the old paradigm of genetic variants leading
to proteins leading to disease is broken and needs to be revised. He looks
at biology as a system of interlocking networks, where thousands of genes are
likely to be implicated in any given disease, together with innumerable
environmental factors, and leading to a wide spectrum of phenotypes and
treatment possibilities in disorders that have traditionally been viewed as
static and absolute. It’s a view that few biologists would likely disagree with
in principle, but even fewer are prepared to study in practice.
Although he has spent time at both Merck and Pacific Biosciences,
Schadt was drawn to become the founding director of the Icahn Institute by the
promise of combining a world-class genomics lab with the Mt. Sinai hospital
system’s impressive vault of clinical data on its patients. “Eric deserves a
lot of credit for organizing and attracting to his group an amazing
constellation of individuals,” says West, who met Schadt through the investor
Carl Icahn, the major donor to the Icahn Institute. West and Schadt quickly
began discussing what kind of system could best deliver insights from network
biology to patients.
“The reason we’ve connected with Eric is that his group’s
work is not just on genomics – it’s really big data, and multiscale biology,”
West continues. “If you see his presentations, he talks about having all kinds
of data feeds that interface with your genome.” LifeMap Solutions is taking
advantage of the Icahn Institute’s shared excitement around uniting different
sources of health information, by imbedding its product development directly in
“It’s not some sort of simple, arm’s-length licensing
arrangement, where we email information back and forth every few weeks,” says
Bridges. “We will have team members located onsite, working side by side with
the Mt. Sinai folks.”
While the combined knowledge of the Icahn Institute and
LifeMap Sciences will be used to turn the spectrum of patient data into usable
health insights, the team is not yet specifying exactly what kind of information
users will receive. Both disease risk reports and behavioral recommendations
have faced tight scrutiny by the FDA, and LifeMap Solutions is wary of
revealing too much while discussions with the agency are ongoing.
The company is, however, stating that its employees at Mt.
Sinai will be building a platform for mobile devices based on the systems
biology approach of the Icahn Institute, which will be the LifeMap Solutions' flagship
product. Bridges expects this platform to be extensible and to evolve over
time. “In a sense, what we’re doing is building a cloud-based operating system
for mhealth access to this holistic health and wellness information,” he says.
“So there will be multiple iterations, multiple apps,” although the beta launch
slated for this year will concentrate on just one app.
Bridges says that the choice to go mobile will help with
consumer access. “Most cell phones in the hands of consumers now are smart
phones, and a lot of computing on the consumer side is moving from desktops and
laptops to mobile devices,” he continues. “That is an irresistible tide, so
that is where consumers are going to be spending their time when they interact
with the Internet or computers.”
There are still many unanswered questions about LifeMap Solutions, but the company joins an accelerating trend to bring greater context and rigor to genetic health insights, reaching out to patients without overstepping regulatory bounds. The day seems once again to be approaching when personalized genetic medicine could be as close and convenient as our smartphones.