Clinical OMICs - Volume 3, Issue 9 - 28
Clinical OMICs SNAPSHOT
How to Address the
FDA's Proposed LDT Framework
Moving from CLIA to QSR
Walt Murray
A
ccurate and reliable diagnostic
tests are the foundation of modern medicine and critical to the future
of patient-centered care. Historically,
the FDA has exerted little oversight of
laboratory-developed tests (LDTs)-
that is, no premarket review or quality system requirements-but this is
changing.
Due to advances in technology,
LDTs have grown exponentially in
number, complexity, and risk, from
simple tests performed by local labs
to diagnose rare diseases or meet the
needs of the local patient population
to intricate genetic tests widely used
to screen for common high-risk diseases like cancer and heart disease.
Unlike traditional LDTs, modern LDTs
are manufactured in large quantities by big corporations-often with
components not legally marketed
for clinical use-and sold nationwide.
28
Clinical OMICs September 2016
The shift in the complexity and
use of LDTs prompted the U.S. FDA
to release the draft guidance Framework for Oversight of Laboratory
Developed Tests (LDTs), expected
to be finalized sometime this year.
The draft has sparked controversy
between the FDA and laboratory
industry groups, most of which advocate building on the existing CLIA
framework. But how can you build
on the existing framework when it
does not allow for robust, risk-based
design, manufacturing or supplier
controls? You cannot. You need good
process, and it has to be GxP.
In my experience, finding a happy
meeting point between CLIA-phites
and Quality-noids can be a pretty
daunting task. I've been involved
with corporate lab clients who have
asked, "Walt, can I get a Ph.D. in lab
science to digest and implement
quality management principles?" My
reply was a shaky, "Yes, but only after
a frontal lobotomy!"
Good Lab Science
Doesn't Necessarily
Equal Good Quality
For some reason, lab management
is perceived as the essence of quality, and therefore, not in need of
additional quality controls. In other
words, if I'm a CLIA-compliant lab,
my LDTs should be safe and perform
as expected because lab science and
quality go hand in hand. Au contraire!
The concept of quality management, which includes the control of
design, suppliers, equipment, people, and methods, has at its core
Murphy's Law: if something can go
wrong, it will, and usually at the
most inopportune time. No one (or
no lab) is insusceptible to this condition. Much like data goes awry for
no apparent reason (and it does hapwww.clinicalomics.com
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
https://www.nxtbook.com/nxtbooks/gen/clinical_omics_vol3iss9
https://www.nxtbook.com/nxtbooks/gen/clinical_omics_vol3iss8
https://www.nxtbook.com/nxtbooks/gen/clinical_omics_vol3iss7
https://www.nxtbook.com/nxtbooks/gen/clinical_omics_vol3iss6
https://www.nxtbook.com/nxtbooks/gen/clinical_omics_vol3iss5
https://www.nxtbook.com/nxtbooks/gen/clinical_omics_vol3iss4
https://www.nxtbook.com/nxtbooks/gen/clinical_omics_vol3iss3
https://www.nxtbook.com/nxtbooks/gen/clinical_omics_vol3iss2
https://www.nxtbook.com/nxtbooks/gen/clinical_omics_vol3iss1
https://www.nxtbook.com/nxtbooks/gen/clinical_omics_vol2iss12
https://www.nxtbook.com/nxtbooks/gen/clinical_omics_vol2iss11
https://www.nxtbook.com/nxtbooks/gen/clinical_omics_vol2iss10
https://www.nxtbook.com/nxtbooks/gen/clinical_omics_vol2iss9
https://www.nxtbook.com/nxtbooks/gen/clinical_omics_vol2iss8
https://www.nxtbook.com/nxtbooks/gen/clinical_omics_vol2iss7
https://www.nxtbook.com/nxtbooks/gen/clinical_omics_vol2iss6
https://www.nxtbook.com/nxtbooks/gen/clinical_omics_vol2iss5
https://www.nxtbook.com/nxtbooks/gen/clinical_omics_vol2iss4
https://www.nxtbook.com/nxtbooks/gen/clinical_omics_vol2iss3
https://www.nxtbook.com/nxtbooks/gen/clinical_omics_vol2iss2
https://www.nxtbook.com/nxtbooks/gen/clinical_omics_vol2iss1
https://www.nxtbook.com/nxtbooks/gen/clinical_omics_issue15
https://www.nxtbook.com/nxtbooks/gen/clinical_omics_issue14
https://www.nxtbook.com/nxtbooks/gen/clinical_omics_issue13
https://www.nxtbook.com/nxtbooks/gen/clinical_omics_issue12
https://www.nxtbook.com/nxtbooks/gen/clinical_omics_issue11
https://www.nxtbook.com/nxtbooks/gen/clinical_omics_issue10
https://www.nxtbook.com/nxtbooks/gen/clinical_omics_issue9
https://www.nxtbook.com/nxtbooks/gen/clinical_omics_issue8
https://www.nxtbook.com/nxtbooks/gen/clinical_omics_issue7
https://www.nxtbook.com/nxtbooks/gen/clinical_omics_issue6
https://www.nxtbook.com/nxtbooks/gen/clinical_omics_issue5
https://www.nxtbook.com/nxtbooks/gen/clinical_omics_issue4
https://www.nxtbook.com/nxtbooks/gen/clinical_omics_issue3
https://www.nxtbook.com/nxtbooks/gen/clinical_omics_issue2
https://www.nxtbook.com/nxtbooks/gen/clinical_omics_issue1
https://www.nxtbookmedia.com