Clinical OMICs - Volume 3, Issue 9 - 3
Molecular Diagnostics in Personalized Medicine
"As a technique offering
higher analytical resolution,
the universal adoption of
LC-MS systems can support
the drive for medical advances
across a broad range of clinical
research and diagnostic
applications."
MARKING THE SWEET SPOT FOR IMMUNOTHERAPIES . . . . . . . . . . . . . . . . . . . . . 8
As immunotherapy revolutionizes the cancer treatment landscape, researchers
are seeking new protein biomarkers to help pinpoint treatment options.
A NEW ERA PREDICTED FOR LC-MS IN THE CLINICAL LAB . . . . . . . . . . . . . . . . .12
LC-MS gains favor due to the high-specificity separation capabilities of liquid
chromatography combined with the analytical power of mass spectrometry.
FDA SEEKS METHODS TO BETTER REGULATE NGS PRODUCTS . . . . . . . . . . . .16
Expanding use of next-generation sequencing has largely occurred outside FDA
oversight, but recent guidance signals its intent to be more active in the future.
DTC-MARKETED TESTS LOOK TO CLINICAL STUDIES FOR GROWTH . . . . . . .20
Developers of direct-to-consumer genetic testing are now leveraging customer
consent to use their data for clinical studies as an avenue for growth.
Regular Features
TUTORIAL . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .24
Streamlined Genomic Sample Collection Speeds Clinical Studies
New, at-home blood collection kit and digital outreach platform allows "anyone,
anywhere, anytime" patient sampling.
SNAPSHOT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .28
How to Address the FDA's Proposed LDT Framework: Moving
from CLIA to QSR With regulation of LDTs on the horizon, clinical labs need
to embrace GxP practices as part of their LDT development strategy.
NEWS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Cover: selvanegra / Getty Images
Above (top): luchschen / Getty Images
(bottom): bluecinema / Getty Images
www.clinicalomics.com
NEW PRODUCTS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .27
MEETING ROUNDUP. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .33
September 2016 Clinical OMICs
3
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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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