Immunotherapy and Cancer: Harnessing the Power of Diagnostic Assays - 17

Immunotherapy and Cancer | Harnessing the Power of Diagnostic Assays
Another example of MolecularMD's ability to ensure accurate test results was
demonstrated in its development of a QC
assay that can help eliminate poor-quality
FFPE samples. This is especially important
for gene expression profiling of the tumor
microenvironment, which has been shown
to be a complementary method to PD-L1
IHC and mutation burden for predicting
checkpoint inhibitor response.
Using FFPE samples of poor quality in these
studies has limited the use of transcriptome sequencing for clinical studies due to
its high costs and low quality samples generating unusable data. To ensure
that only FFPE samples
are used that will generate usable data,
the company

17

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and its focus
on optimizing
and improving
existing assays, is
something that sets
MolecularMD apart from
other diagnostic developers.

created a simple 5-plex RT-qPCR assay to
measure the expression of 5 housekeeping
genes. "This QC assay helps us to eliminate
poor FFPE samples and ensure the accuracy of the assay and lower the assay cost
for our sponsors," Li says.
According to Spittle the use of multiple
technologies and platforms for its work,

"There are a lot of assays out
there, but they are manufactured
and meant for research use only," Spittle concludes. "We look at whether we
can take one of the those tests, optimize
it, change it, and modify it to make it a
better assay to be used in a clinical setting. Or if there aren't any commercial
assays out there for the intended use, we
can also develop our own custom assays
using the best platform for the biomarker
of interest."

www.clinicalomics.com

http://www.clinicalomics.com

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