OMAHA, Neb.--(BUSINESS WIRE)--Transgenomic, Inc. (NASDAQ:TBIO), today announced that it is launching a new pilot clinical study of its Multiplexed ICE COLD-PCR™ (MX-ICP) liquid biopsy technology. Four leading global biopharmaceutical firms have joined the pilot program, which was initiated with an undisclosed market-leading oncology company earlier this year. The primary aim of the study is to validate the accuracy and utility of using MX-ICP-based liquid biopsies, which analyze circulating tumor DNA in the blood to guide and monitor cancer clinical trials. The study will include a variety of cancers and several different sequencing platforms.
In this pilot study, Transgenomic will have access to patient blood samples from the participating companies’ relevant clinical trials, allowing it to generate supporting data to show the correlation between genomic analyses from FFPE tissue samples and those obtained using plasma samples enriched with Multiplexed ICE COLD-PCR.
“One of the most important attributes of our MX-ICP technology is its potential for enabling the routine use of DNA analyses to guide and monitor cancer treatment, by replacing invasive and costly tissue biopsies with easily-accessible blood tests,” said Paul Kinnon, President and Chief Executive Officer of Transgenomic. “We are delighted that four well-known biopharma companies are working with us on this pilot study. As we have already shown in our own studies, we expect to validate for our partners that MX-ICP liquid biopsies are comparable or superior to DNA analyses obtained from conventional FFPE tissue samples. We believe liquid biopsies will ultimately improve a clinician’s ability to diagnose and treat cancer, and they should also help to improve patient stratification in clinical trials and accelerate FDA submissions, providing a near-term advantage to our collaborators and customers. A similar pilot study partnered with another major oncology company that we started earlier this year is going very well, fueling our optimism that these studies will confirm the broad potential of MX-ICP liquid biopsies in diagnosing, monitoring and managing cancer.”
Multiplexed ICE COLD-PCR was developed for the ultra-sensitive detection of very low level genetic alterations, making it a useful tool for the identification of cancer biomarkers, acceleration of cancer research and implementation of personalized approaches to cancer diagnosis and treatment. The technology works with virtually any type of patient sample, including tissue, blood, plasma, and urine. Its ultra-high sensitivity routinely achieves levels of detection down to 0.01%, delivering a 100-fold or greater improvement in sensitivity compared to standard methodologies. MX-ICP is compatible with all current sequencing platforms, including Sanger sequencing, next-generation sequencing (NGS) and digital PCR. It is robust, easy to use, and is easily implemented with minimal changes to established sequencing workflows. Transgenomic has recently added quantification capabilities to the technology, further extending its utility for cancer patient monitoring.
Earlier this month, Transgenomic launched its ICEmeTM Mutation Enrichment Kits for cancer researchers worldwide. MX-ICP technology is also available to pharmaceutical and biotechnology customers of the company’s Biomarker Identification business unit. For more information on currently available Multiplexed ICE COLD-PCR products and services, visit http://www.transgenomic.com/technology/mx-icp/.
Multiplexed ICE COLD-PCR was discovered in the laboratory of Dr. Mike Makrigiorgos at the Dana-Farber Cancer Institute, which has exclusively licensed rights to the technology to Transgenomic.
Transgenomic, Inc. is a global biotechnology company advancing personalized medicine in cardiology, oncology, and inherited diseases through advanced diagnostic technologies, such as its revolutionary ICE COLD-PCR™ and its unique genetic tests provided through its Patient Testing business. Transgenomic also provides specialized clinical and research services to biopharmaceutical companies developing targeted therapies and sells equipment, reagents and other consumables for applications in molecular testing and cytogenetics. Transgenomic’s diagnostic technologies are designed to improve medical diagnoses and patient outcomes.
Certain statements in this press release constitute “forward-looking statements” of Transgenomic within the meaning of the Private Securities Litigation Reform Act of 1995, which involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. Forward-looking statements include, but are not limited to, those with respect to the expected timing for the availability of additional mutations with the ICEme kits, the potential uses for the ICEme kits, the effectiveness of the ICEme kits and Multiplexed ICE COLD-PCR technology, the availability of the ICEme kits for diagnostic use and expectations regarding the ICEme kits’ and Multiplexed ICE COLD-PCR’s ability to facilitate the development of Transgenomic’s pipeline. The known risks, uncertainties and other factors affecting these forward-looking statements are described from time to time in Transgenomic's filings with the Securities and Exchange Commission, including in Transgenomic’s Annual Report on Form 10-K, filed with the Securities and Exchange Commission on April 15, 2015. Any change in such factors, risks and uncertainties may cause the actual results, events and performance to differ materially from those referred to in such statements. Accordingly, the Company claims the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995 with respect to all statements contained in this press release. All information in this press release is as of the date of the release and Transgenomic does not undertake any duty to update this information, including any forward-looking statements, unless required by law.