Immunotherapy and Cancer: Harnessing the Power of Diagnostic Assays - 14

Immunotherapy and Cancer | Harnessing the Power of Diagnostic Assays
Thoughtfully planned biomarker assay development and validation using standardized methodologies will improve our
understanding of the clinical utility of a biomarker assay for
patient enrollment. A clinical trial assay (CTA) should be the
prototype for the development of a complementary or companion diagnostic assay that will accelerate drug approval.
This decreases development costs, improves time-to-market,
and return on investment.
CO: What are some of the challenges as a biomarker

assay makes the journey from concept to an in vitro
diagnostic?

CS: In both CTA and IVD assay development, the sample type,
sample quality and sample availability need to be considered. WGS and WES typically utilize DNA and RNA extracted
from fresh or frozen tumor tissue. While this may be suitable
in research studies, it is not practical in clinical trials or clinical

A Clinical OMICs eBook

practice since these sample types are not readily available.
Likewise, an assay that requires a large amount of tissue or
blood is not pragmatic. The amount of tissue, blood or plasma
that is needed for a diagnostic assay has to align with what is
routinely available.
CO: How is MolecularMD addressing these challenges?
CS: MolecularMD has over 10 years of experience in developing
and validating CTA and IVD assays and supporting global
clinical trials. We have obtained IDE approval for PCR, NGS
and IHC-based assays. We have built an infrastructure which
is agile and capable of bringing value and insight to drug
development programs from early Phase 1 through drug
and diagnostic approval. We offer the scientific, regulatory
and operational expertise that provides a continuum of support that can carry an assay from RUO to clinical trial/IDE
to IVD.

www.clinicalomics.com

http://www.clinicalomics.com

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