Immunotherapy and Cancer: Harnessing the Power of Diagnostic Assays - 16

Immunotherapy and Cancer | Harnessing the Power of Diagnostic Assays
The solution to this problem is the development of a standardized commercial
panel that can be used at a broad array of
labs and will return consistent results for
both high tumor burden and low tumor
burden. This is an area of expertise for
MolecularMD, which has built a reputation
of taking research-only assays and optimizing them for use in the clinic.
"There is a very big difference between the
world of a research laboratory and that of
a clinical laboratory," notes Cindy Spittle,
MolecularMD's vice president of development and scientific affairs. "That is where
MolecularMD is unique: we help bridge
between what is used as a research assay
and what can be used in a clinical setting in
making patient treatment decisions. That
started with our very first test for BCR-ABL
and taking that from the research setting
all the way to the FDA. We can apply those
same lessons learned to the world of immunotherapy biomarker assays."
One example of this expertise was pre16

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Ion Torrent ™ Ion GeneStudio ™ S5 XL for next generation
sequencing workflow at MolecularMD.

	
sented earlier this year at the AACR Annual
Meeting in Chicago, where the company
showed how it improved ThermoFisher's
TML panel for TMB analysis using clinical
FFPE samples. According to Li, his lab first
looked to correlate the results from the targeted panel with exome sequencing, and
showed excellent correlation of the 16 FFPE
samples tested. But when it came to FFPE
samples with variable quality, the results
were mixed. Good quality samples provide
accurate TMB measurements, but the test
overestimated TMB in poorer quality samples due to deamination.

MolecularMD saw an opportunity to
increase the value of the Thermo Fisher
assay so that it could be used for FFPE
samples of varying quality. It did so by first
using a duplicated TML assay which significantly reduced errors from FFPE samples
by 98%. Realizing that running duplicate
analysis came with a high cost, Li and team
conducted in silico analysis of running
duplicated library preps at half coverage
and proved it was as accurate and could
keep costs in line.
"This shows how we bridge from the
Research Use Only (RUO) to the clinical
assay," Li notes. "If you strictly follow Thermo's protocol for everything, you might
get some wrong results. We
improved the workflow, and
proved it works with
our bioinformatics,
to ensure the
accuracy of
our results."

www.clinicalomics.com
http://www.clinicalomics.com
Table of Contents for the Digital Edition of Immunotherapy and Cancer: Harnessing the Power of Diagnostic Assays
