Rise of Genomics in Clinical Trials - 11

Rise of Genomics in Clinical Trials * A Proper Match: New NGS Method Up to Snuff for Tumor Analysis in NCI-Match Clinical Trial

and reproducibility of next-generation sequencing (NGS) for application in
clinical trials. However, investigators involved with NCI-MATCH set out to
address whether the methodologies were valid that the clinical centers
were using to isolate, sequence, and analyze the array of tumor samples
being collected.
Now, a recent report in the Journal of Molecular Diagnostics-entitled
"Analytical Validation of the Next-Generation Sequencing Assay for a
Nationwide Signal-Finding Clinical Trial"-confirms that the assay tailored
for this trial is highly sensitive for detecting genetic mutations from a
variety of tumor tissue and, for the first time, has been reproduced with
accuracy by multiple clinical laboratories, laying the groundwork for
future clinical utility. The results clearly show that locked and controlled
procedures permit the reliable, accurate, and reproducible use of NGS for
clinical purposes.
The NCI-MATCH investigators, using the Oncomine Cancer Panel assay
and the Personal Genome Machine, were able to detect more than 4,000
predefined genomic variations across 143 genes, including single nucleotide variants (SNVs), insertions/deletions (indels), copy number variations
(CNVs), and gene fusions.
*NCI-Molecular Analysis for Therapy Choice

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"We report the analytical validation processes for the NGS assay that
was tailored for regulatory compliant use in the trial," the authors wrote.
"The Oncomine Cancer Panel assay and the Personal Genome Machine

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Rise of Genomics in Clinical Trials

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