Q2 Solutions, the joint venture between QuintilesIMS and Quest Diagnostics, will collaborate with EA Genomics and Illumina to establish a framework for developing next-generation sequencing-based (NGS) CDx assays.
According to the organization, the portfolio expansion with further enhance its services, which range from biomarker discovery and development, to the application of precision medicine through its clinical trials laboratory network.
Per the agreement, Q2 Solutions will develop NGS assays using the Illumina MiSeqDx® instrument – the first of its kind to be cleared by the US Food and Drug Administration (FDA) for in vitro diagnostic purposes in clinical laboratories.
“An effective CDx strategy can improve the overall probability of success of Q2 Solutions’ sponsors’ programs and has regulatory implications as well,” Phil Bridges, Senior Director, Corporate Communications, QuintilesIMS, told Outsourcing-Pharma.com.
Specifically, the US Food and Drug Administration (FDA) issued a guidance in July of this year in which is recommends the co-development of IVD CDx and therapeutics.
“By implementing genomic biomarker signatures with a CDx path in clinical trials, we can streamline trials by enrolling patients that are likely to respond to the therapeutic and less likely to have an adverse event,” said Bridges.
“This ultimately generates a stronger package for submission to the FDA,” he added. “Using NGS-based CDx development and deployment strategies are essential to enable the future of precision medicine.”