On June 14, 2016 Transgenomic, Inc. (TBIO), (NASDAQ: TBIO), reported plans to expand its ICE COLD-PCR (ICP)-powered cancer assays ten-fold over the next 18 months, targeting a portfolio of more than 200 exons/mutations expected to be available to partners, cancer researchers, drug developers and clinicians by 2018 (Press release, Transgenomic, JUN 14, 2016, View Source [SID:1234513324]). Multiplexed ICP technology’s ultra-high sensitivity down to 0.01% makes it possible to run ICP assays using either tissue, blood or serum samples on any sequencing platform. Recently-released studies indicate high concordance between ICP detection tests and assays produced using conventional technology, with the added benefit that the ICP tests detected mutations in both plasma and tissue samples that were missed by conventional methods.
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The expanded ICP cancer test menu will be released over the course of the next 18 months, with about 10 new exons/mutations expected to be issued every 6-8 weeks. The new tests will available in several formats–for use by TBIO’s partners and licensees, through TBIO’s Biomarker Discovery Services group and Oncology CLIA laboratory, as well as through its ICEme kits, which customers can run on Sanger, NGS and other platforms in their own laboratories. The focus, as with TBIO’s current menu of detection tests and panels, will be on actionable mutations relevant to cancer treatment decisions, with priority given to mutations requested by customers along with those newly validated by cancer researchers. The company also intends to incorporate some of the added mutations into panels for use with specific cancers and tumor types.
TBIO President and CEO Paul Kinnon commented, "The rapidly growing use of genomic testing as an essential part of cancer treatment makes this a good time to build on the foundation we have created over the past year and to exponentially expand the menu of tumor exons/mutations that can be tested using our ICP technology. We have refined and industrialized the development of new tests, as we demonstrated with the recent rapid development and release of our EGFR C797S ICP assay. We therefore believe that our ambitious goal of offering more than 200 exons/mutations by 2018 is achievable. We are optimistic that the accuracy, versatility, ease of use and rapid turnaround of ICP cancer testing, along with its availability in multiple formats and on a variety of platforms, will generate strong demand as we expand the test menu. We look forward to working with a range of customers and diagnostic laboratory partners to apply the power of TBIO’s expanded ICP product line to accelerate cancer research and improve patient outcomes."
ICE COLD-PCR achieves its ultra-high sensitivity through selective amplification of mutant DNA. The result is up to a 500-fold increase in sensitivity in identifying mutations with the most precise sequence alteration detection rates available. ICP was originally developed by the laboratory of Dr. Mike Makrigiorgos at the Dana-Farber Cancer Institute, which has exclusively licensed rights to the technology to Transgenomic.