Collaborative Studies Validating Transgenomic’s ICE COLD-PCR Technology Highlighted in Educational Materials at Major Upcoming Cancer Meeting

Visit Booth #14081 to Learn How ICE COLD-PCR’s Ultra High Sensitivity Enables the Use of Non-Invasive Liquid Biopsies for Cancer Detection, Monitoring and Treatment

Study Confirms Multiplexed ICE COLD-PCR Can Achieve Sensitivities of <0.01% on Sanger and NGS Sequencing Platforms for Multiple Reactions Run on a Single Plate

2014 ASCO Annual Meeting

OMAHA, Neb.--()--Transgenomic, Inc. (NASDAQ: TBIO), a global biotechnology company advancing personalized medicine in cardiology, oncology, and inherited diseases through advanced diagnostic tests and clinical and research services, today announced that educational materials discussing its ICE COLD-PCR (ICP) technology will be available at its booth at the 2014 ASCO Annual Meeting. The studies described in the materials provide further validation of key features of Transgenomic’s ICP technology. They were conducted by company researchers working on their own as well as in collaboration with scientists at the University of Texas MD Anderson Cancer Center and the Dana-Farber Cancer Institute.

The studies highlight the ability of the ICP technology to detect relevant tumor mutations with high sensitivity from the blood or plasma of cancer patients. They show that ICP can detect a variety of known and unknown mutations, and it can do so repeatedly over time, providing a longitudinal view of changes in mutation status as treatment proceeds. Importantly, the studies confirm that ICP can achieve sensitivities of less than 0.01%, the level needed for accurate detection of tumor mutations from non-invasive samples such as plasma. They also show that a multiplexed version of the ICP technology can accurately detect multiple mutations, emphasizing the potential efficiency and practicality of the approach.

Key specific findings in the studies include the following:

  • ICP is a method that achieves high sensitivity by preferentially amplifying low levels of mutant DNA in samples containing vast amounts of wild-type (normal) DNA, producing linear amplification of the wild-type sequences but exponential amplification of any mutant sequences present.
  • ICP technology is capable of high sensitivity detection of both point mutations and insertion/deletions in tumor DNA.
  • ICP detects actionable gene mutations using the cell-free DNA found in the plasma of cancer patients--in one study mutations were detected in BRAF and KRAS genes.
  • Using plasma cell-free DNA, ICP can produce longitudinal assessments of tumor mutations over time, detecting changes during cancer therapy that appear consistent with the clinical course of the disease.
  • Transgenomic’s new multiplexed version of ICE COLD-PCR (MX ICP) achieved sensitivities of <0.01% on Sanger and Next Generation Sequencing (NGS) platforms using a single plate to process six different reactions. Results were consistent with the same analysis done using six separate reactions and plates.
  • Combining ICP with a magnetic bead-based technology known as DISSECT further enhances the sensitivity of the approach, and it can be efficiently run as a single multiplexed reaction. This is in contrast to other high sensitivity methodologies, which rely on allele-specific capture probes and therefore require a new probe to be developed and validated for each new mutation that is discovered.

Paul Kinnon, President and Chief Executive Officer of Transgenomic, commented, “Our work with researchers at leading cancer centers is producing a growing body of studies that confirm the extraordinary performance of ICE COLD-PCR technology in enabling the accurate detection of tumor mutations from patient blood or plasma. We believe the multiplexed version of the ICP technology, which we recently licensed from Dana-Farber, has the potential to make individualized cancer detection, monitoring and treatment a practical reality. We look forward to sharing these studies with researchers and clinicians at this most important cancer meeting of the year.”

The educational material will be available at Transgenomic’s Booth #14081 and will be available on the Transgenomic website at the conclusion of the ASCO Annual Meeting. They include:

  • BRAF and KRAS Mutation Testing in Plasma Cell-Free DNA with ICE COLD-PCR in Patients with Advanced Cancers, F Janku, B Legendre, K Richardson, G. Falchook, A Naing, VR Holley, S Fu, DS Hong, SA Piha-Paul, JJ Wheler, RG Zinner, V Subbiah, AM Tsimberidou, DD Karp, VM Stepanek, G Cabrilo, R Luthra, F Meric-Bernstam, AY Bedikian, BK Kee, C Eng, Micahel, J Overman, KB Kim, A Kruempel, J Pope, C Cubrich, G Wu, M Lewis, R Kurzrock
  • Multiplexed ICE COLD-PCR (MX ICP): A Highly Sensitive Mutation Detection Methodology with Sensitivities <0.01% on Sanger and NGS on a Single Plate, BL Legendre, Jr., S Cherubin, C Cubrich, A Dowers, S Jansen, A Kruempel, P Krzycki, E McCutchen, E Montague, S Peterson, J Pope, K Scott, J Stoddard, G Wu, K Richardson
  • Combination of DISSECT and COLD-PCR Technologies for Ultra-Sensitive Detection of Mutations Using Either Sanger or Next Generation Sequencing Methodologies, G Wu, C Song, R Lin, K Scott, S Jensen, C Cubrich, E Montagne, A Kruempel, B Legendre, Jr, GM Makrigiorgos, K Richardson

About ICE COLD-PCR
ICE COLD-PCR (ICP) selectively amplifies only the mutated DNA in tumors that is useful for cancer diagnosis, monitoring and treatment. It detects mutated DNA at very high sensitivity—initial validation studies show it is 100-400 fold more sensitive than conventional approaches. ICP also enables identification of all tumor mutations – both those already known as well as new mutations not detected before. The ultra-high sensitivity of ICE COLD-PCR allows DNA testing to be done using easily accessible samples, such as blood, plasma and urine, eliminating the need for invasive, painful and expensive tumor biopsies. By enabling these liquid biopsies, ICP makes it possible to conduct repeated assessments of disease status as cancer therapy proceeds, providing valuable information to help guide treatment decisions. ICE COLD-PCR can also analyze DNA from fine needle aspirates, core biopsies, or directly from tumors. It can be used with standard Sanger sequencing, next generation sequencing, digital PCR and other technologies.

About 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-PCRTM and its unique genetic tests provided through its Patient Testing business. The company 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.

Forward-Looking Statements
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. 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. 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.

Contacts

Media Contact:
BLL Partners LLC
Barbara Lindheim, 212-584-2276
blindheim@bllbiopartners.com
or
Investor Contact:
Argot Partners
Susan Kim, 212-600-1902
susan@argotpartners.com
or
Company Contact:
Transgenomic, Inc.
Donna Christian, 402-452-5416
investorrelations@transgenomic.com

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Contacts

Media Contact:
BLL Partners LLC
Barbara Lindheim, 212-584-2276
blindheim@bllbiopartners.com
or
Investor Contact:
Argot Partners
Susan Kim, 212-600-1902
susan@argotpartners.com
or
Company Contact:
Transgenomic, Inc.
Donna Christian, 402-452-5416
investorrelations@transgenomic.com