ICON_Jan2021_CellandGeneTherapy - 25

Cell and Gene Therapy Clinical Trials - The Promise and Complexity of Living Therapies

providing vector copy number testing to sponsors,

the therapy promises to provide more accuracy

as very few commercial labs had perfected use of

compared with the traditional antibody methods of

testing with that platform.

HLA typing.

Another area of testing unique to the lab was the
use of RT-qPCR, which is used to help identify the

CLIA lab services

target of a cellular therapy. " For instance, there are

When it comes to monitoring a patient's response to

several different programs where engineered cell

a candidate therapy in a clinical trial, samples must

therapies are targeting something like MAGE-a

be collected from patients to assess both efficacy

unique antigen expressed in solid tumor cells, " Spittle

and potential toxicity. Any testing that determines

explains. " Our ability to develop custom RT-qPCR

how a patient will be treated or dosed in a CGT trial

assays to identify tumors that express this unique

will need to be conducted in a CLIA-certified and/or

target was another niche for us in cell and gene

CAP-approved laboratory.

therapy programs. " Being able to test for appropriate

For instance, many gene therapies use viral

targets is increasingly common as more therapies are

vectors as their means of delivery for that gene. With

developed for the treatment of solid tumors.

adenovirus vectors, there is the need for immunoge-

HLA typing is also important within CGT trials.

nicity testing as some patients can have pre-existing

Moving to high-sensitivity sequencing-based

antibodies to the adenovirus vectors being used.

methods to test patients for compatibility with

" So, we would be testing for patient safety, patient
ClinicalOMICs.com

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ICON_Jan2021_CellandGeneTherapy

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