The Questions We Always Face in Every One of Our Clinical Trial Discussions…

Written by: JaredJacobson MBA, MMB
Market Development Associate

Published on:
July 27th, 2016

Jared Jacobson
Jared Jacobson, Market Development Associate, is a Masters of Business Administration and Microbial Biotechnology graduate of North Carolina State University. He spearheads early biopharma marketing efforts and supports the broader business development team in account engagement and customer management.

  • How often has the testing strategy in your clinical trial been limited by sample availability?
  • What possible biomarker targets have you had to eliminate due to budget constraints?
  • How do you parse the data you generate and develop actionable results?

Providing solutions to these pragmatic and critical issues drove CGI’s decision to validate the Focus::Oncomine™ NGS assay.

Focus::Oncomine™ was recently CLIA approved making it appropriate for translational and clinical research across solid tumor indications. A powerful, cost-effective, universal biomarker solution to address the needs of complex trial designs, backed by CGI’s quality systems and run two of our CLIA and CAP certified laboratories.

Focus::Oncomine™ is built from Thermo Fisher Scientific’s Oncomine Focus assay, includes the powerful Ion AmpliSeq™ library preparation technology and runs on the proven Ion Torrent™ NGS platform. 52 key genes are targeted that have direct relevance to marketed therapeutics and founded on published evidence from the National Comprehensive Cancer Network (NCCN), College of American Pathologists (CAP), and American Society of Clinical Oncology (ASCO). The chemistry utilizes a single workflow to simultaneously test both DNA and RNA. Typically only 3 – 4 FFPE slides are required, or as little as 10 ng of DNA or RNA per pool. This allows testing of thousands of possible mutations across 35 gene hotspots, 19 genes associated with copy number variations, and 23 fusion genes.

At the exciting new frontier for the Oncomine™ Platform is in cfDNA analysis. Liquid biopsy will open up new possibilities for patients and clinicians to gain critical diagnostic insights with less cost, less invasiveness, less time, and less susceptibility to tumor heterogeneity. In contrast to the comprehensive design of Focus::Oncomine™, the first of these cfDNA assays will be developed as tumor-type specific. CGI is currently working towards commercial release of the Oncomine™ Lung cfDNA Assay. The impressive results reach detection levels down to 0.1%, with 90% sensitivity and >98% specificity for SNV hotspots and indels. This is achieved in a seamless workflow utilizing only a single blood sample and as little as 1 ng of input DNA. Quickly and accurately assess high value biomarker targets such as EGFR T790M and L858R mutations.

At CGI we take pride in transforming cutting edge diagnostic technologies into standard of care. Focus::Oncomine™ is the newest tool in our bag. Find out what is coming next.

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