Clinical OMICs - Volume 3, Issue 9 - 25
New, At-Home
Blood Collection Kit and
Digital Outreach Platform
Allows "Anyone, Anywhere,
Anytime" Patient Sampling
ulation on the clinical testing industry. Conversely, the clinical testing
industry does not want increased regulation and argues that the FDA does
not have the authority, and that these
rare instances of problem tests can be
effectively policed using an enhanced
CLIA licensing system that is administered by the Centers for Medicare
& Medicaid Services (CMS). While the
final outcome of the FDA's push for
more oversight of LDTs is unclear, it
is becoming increasing evident that
the industry is in need of a rapid and
affordable solution for running largescale clinical studies.
Traditionally, genomic studies
employ a "physician-centric" study
model popularized by the pharmaceutical industry for drug development. It
relies upon doctors to identify, recruit,
and enroll patients in a study. While
very scientifically sound, this model
is limited by patient throughput and
www.clinicalomics.com
Clicknique /
Getty Images
also requires paying for the physi- Administration, is a step in the right
cian's time and expertise. Recruiting direction toward improving the ecothousands of patients for a large- nomics of test validation. The PMI
scale study often requires 50 or more cohort program seeks to extend prestudy sites across
cision medicine
a broad geographto all diseases
ical area, and
by building a
In addition to providing a large,
each site requires public dataset that can be used to national cohort
individual con- support the discovery of promising of one million or
tract negotiations,
more U.S. particgenomic tests, the PMI cohort
protocol trainipants. The goal
program also will investigate
ing, Institutional new modalities for recruiting and is to accumulate
Review
Board
actionable informonitoring patients with a focus
(IRB) approval,
mation to signifion patient engagement.
and monitoring.
cantly increase
A study can take
the accuracy of
several years and can cost between scientific predictions both during
$10 million and $100 million to com- research and in the clinic.
plete.
In addition to providing a large,
public dataset that can be used to
PMI Tackles
support the discovery of promising
Test Validation costs
genomic tests, the PMI cohort proThe Precision Medical Initiative (PMI), gram also will investigate new modalannounced in 2015 by the Obama
(continued on next page)
September 2016 Clinical OMICs
25
http://www.clinicalomics.com
Table of Contents for the Digital Edition of Clinical OMICs - Volume 3, Issue 9
Contents
Clinical OMICs - Volume 3, Issue 9 - Cover1
Clinical OMICs - Volume 3, Issue 9 - Cover2
Clinical OMICs - Volume 3, Issue 9 - Contents
Clinical OMICs - Volume 3, Issue 9 - 4
Clinical OMICs - Volume 3, Issue 9 - 5
Clinical OMICs - Volume 3, Issue 9 - 6
Clinical OMICs - Volume 3, Issue 9 - 7
Clinical OMICs - Volume 3, Issue 9 - 8
Clinical OMICs - Volume 3, Issue 9 - 9
Clinical OMICs - Volume 3, Issue 9 - 10
Clinical OMICs - Volume 3, Issue 9 - 11
Clinical OMICs - Volume 3, Issue 9 - 12
Clinical OMICs - Volume 3, Issue 9 - 13
Clinical OMICs - Volume 3, Issue 9 - 14
Clinical OMICs - Volume 3, Issue 9 - 15
Clinical OMICs - Volume 3, Issue 9 - 16
Clinical OMICs - Volume 3, Issue 9 - 17
Clinical OMICs - Volume 3, Issue 9 - 18
Clinical OMICs - Volume 3, Issue 9 - 19
Clinical OMICs - Volume 3, Issue 9 - 20
Clinical OMICs - Volume 3, Issue 9 - 21
Clinical OMICs - Volume 3, Issue 9 - 22
Clinical OMICs - Volume 3, Issue 9 - 23
Clinical OMICs - Volume 3, Issue 9 - 24
Clinical OMICs - Volume 3, Issue 9 - 25
Clinical OMICs - Volume 3, Issue 9 - 26
Clinical OMICs - Volume 3, Issue 9 - 27
Clinical OMICs - Volume 3, Issue 9 - 28
Clinical OMICs - Volume 3, Issue 9 - 29
Clinical OMICs - Volume 3, Issue 9 - 30
Clinical OMICs - Volume 3, Issue 9 - 31
Clinical OMICs - Volume 3, Issue 9 - 32
Clinical OMICs - Volume 3, Issue 9 - 33
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