oCtoBeR 2010 - American Association for Clinical Chemistry

Clinical
Laboratory
News
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editor—Nancy Sasavage, PhD
senior editor—Genna Rollins
associate editor—Bill Malone
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Michael Schlosser, PhD, and Alistair J. K. Williams
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Mayo Clinic, Rochester, Minn.
Andrew Don-Wauchope, MD
McMaster University Medical Center
Hamilton, Ontario
Steven Goss, PhD
Siemens Healthcare Diagnostics, Newark, Del.
Mary Kimberly, PhD
CDC, Atlanta, Ga.
Amy Saenger, PhD
Mayo Clinic, Rochester, Minn.
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president-elect—Ann Gronowski, PhD
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past-president—Barbara Goldsmith, PhD
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Nancy Sasavage, PhD, Editor
Clinical Laboratory News
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4 CliniCal laboratory news oCtoBeR 2010
Complex Problems Require Teamwork
future of medicine, continued from page 3
what population responds in a certain way
to a drug, you can tailor it better to different
populations. It’s not easy to manufacture
drugs in a way that’s tailored to particular
parts of the market. This will allow that to
be done in the future,” Thomson explained.
Already, several promising treatments
based on stem cell therapy have been announced,
and at least two received Food
and Drug Administration (FDA) approval.
For instance, in July, FDA approved the
first-ever clinical trial in humans for an ES
cell-based therapy that has worked in mice.
This therapy, based on one of the cell lines
Thomson developed in the 1998, will be
used to treat patients paralyzed because of
severe spinal cord injuries.
These developments are but the start of
many exciting and groundbreaking discoveries
ahead, according to Thomson. Stem
cell therapy “is a very powerful, pervasive,
enabling research tool and where creative
people will take that, I have no idea. But I
would be shocked if these cells aren’t found
to be important 10 to 20 years from now,”
he said.
Unlocking the Mystery
of Alzheimer’s Disease
Trojanowski, recipient of AACC’s 2010
Wallace H. Coulter Lectureship Award,
painted an exciting and optimistic portrait
of future diagnostics and treatments for
Alzheimer’s disease, which some consider
the disease of the 21st Century owing to the
fact that people are living longer than ever
before. “We’re in the midst of a longevity
revolution. There’s been a nearly doubling
of life expectancy over the past century,” he
explained. “From the time Dr. Alzheimer
made his initial presentation about the disease
in 1906, people thought it was an odd
disorder and certainly didn’t appreciate
that it would become epidemic 100 years
later.”
The ‘silver tsunami’ of baby boomers
who will start turning age 65 in 2011 will
escalate the incidence of the already prevalent
neurodegenerative disorder. An estimated
13 million people in the U.S. will
have Alzheimer’s disease by 2025, up from
about 5 million today. However, treatments
that would slow the disease by even 5 years
would decrease both the prevalence of and
costs associated with the condition by about
50% by 2050, according to Trojanowski. He
is co-director of the Center for Neurodegenerative
Disease Research and William
Maul Measey-Truman G. Schnabel, Jr. MD
professor of geriatric medicine and gerontology
at the University of Pennsylvania in
Philadelphia.
Slowing down the disease is what researchers
are striving for, and after years
of investigation, Trojanowski finally believes
it’s about to happen. “When I first
started working on Alzheimer’s disease in
the 1980s, I thought it would be 100 years
after I was dead that people would be having
conversations about the tremendous
research focused on the disease, but the
advances of science have been spectacular
in the last 30 years,” he said. “We’re within
striking distance of having biomarkers that
can ‘go live’ in clinics, and within striking
distance of having disease-modifying
therapies.”
A Landmark Investigation
Trojanowski’s lab has been on the forefront
of Alzheimer’s-related research, and is the
biomarker core lab for the Alzheimer’s
Disease Neuroimaging Initiative (ADNI),
a landmark, 6-year, $67 million clinical
trial aimed at studying changes in cogni-
tion, brain structure and function, and biomarkers
in elderly controls, subjects with
mild cognitive impairment, and subjects
with Alzheimer’s disease. Although the first
phase of ADNI just concluded in September,
the trial already has made significant
contributions to the field. In Trojanowski’s
view, one of the most notable has been
standardization of procedures and analytics
involving collection and processing of
cerebrospinal fluid. “There had been a lot
of informative work done in the past, but it
was hard to see how the data could be used
clinically, because people had been using
different collection procedures, reagents,
and assays. ADNI has achieved standardization
of all things necessary to have reliable
biomarkers,” he explained.
ADNI researchers also published results
in August reporting the presence of an Alzheimer’s
disease biomarker signature of
β-amyloid protein 1–42, total tau protein,
and phosphorylated tau181P in 90% of Alzheimer’s
disease patients, three-quarters
of those with mild cognitive impairment,
and one-third of normal controls (Arch
Neurol 2010;67:949–56). In patients with
mild cognitive impairment followed for 5
years, the signature also showed a sensitivity
of 100% in patients who progressed to
Alzheimer’s. “We now know that Alzheimer’s
is probably present in the brain about
10 years before evidence of impairment,
and we can see the signal of biomarkers
in people who are cognitively normal but
have that pathological profile. It makes us
think they’ll convert to Alzheimer’s over
time,” said Trojanowski.
ADNI also lead to a world-wide network
of Alzheimer’s disease-related clinical
trials, and in one of the first such arrangements,
data from the trial are being posted
and regularly updated on a publicly accessible
website available to researchers world-
wide. ADNI organizers expect the open
data policy will speed additional Alzheimer’s-related
research.
A Minor Setback
Although right now there’s little physicians
can offer patients who have the Alzheimer’s
disease biomarker signature, Trojanowski
sees only blue skies for the development of
treatments. He even is undaunted by the recent
failure of a highly anticipated drug trial.
“We’re within striking distance of having biomarkers that can ‘go live’ in
clinics, and within striking distance of having disease-modifying therapies,”
said John Trojanowski, md, phd.
In August, Eli Lily & Company halted study
of semagacestat after it became evident that
the drug not only did not slow progression
of the disease, but was associated with
worsening cognition. With more than $1
billion invested in at least 100 clinical trials,
Trojanowski anticipates that sooner or later
there will be a successful candidate therapy.
The first drug that shows even modest benefits
over symptomatic treatment will shift
the focus towards finding treatments that
will have a more significant therapeutic effect
earlier in the disease process.
All of this has important implications
for labs, according to Trojanowski. “The
public demand is there, and people will line
up for lumbar punctures so they’ll know if
they take the drug it will help them. Prepare
now for long lines at a lab in your neighborhood,”
he joked.
Science as a Team Sport
Treatment or even prevention of Alzheimer’s
disease in our time. Successful
use of iPS cells in regenerative medicine,
drug discovery, and other applications not
envisioned today. A new paradigm that
harnesses powerful computational and
analytic tools to provide completely personalized,
wellness-focused medicine. On
the surface, these visions, although equally
ambitious, complex and compelling, have
little in common. However, they share the
philosophy that breakthrough science is a
team undertaking.
“The same thing that’s been happening
in my lab is the same thing that’s happening
in science as a whole,” said Thomson. “The
problems we are addressing have become
so complex that we have to collaborate,
we have to reach out to other disciplines,
and bring engineering and computational
biology together if we want to solve these
greater problems.” CLN