Educational Handout Introduces New Data Confirming Concordance and Utility of ICP Liquid Biopsy Results; Presentation Showcases Advanced EGFR Biomarker Assays for Lung Cancer          

Visit Booth #1356 to Learn How ICE COLD-PCR’s High Sensitivity and Versatility Enable Rapid Biomarker Development and Facilitate Use of Liquid Biopsies for Mutation Detection and Monitoring                                    

 NEW ORLEANS, LA and OMAHA, NE (March 29, 2016) — Transgenomic, Inc. (NASDAQ: TBIO), today announced that company scientists will present new data at the upcoming American Association for Cancer Research (AACR) 2016 Annual Meeting highlighting the utility of its ICE COLD-PCR (ICP) technology for liquid biopsy detection of tumor mutations. Transgenomic researchers will host a poster presentation that showcases its advanced EGFR biomarker assays with the potential to help optimize the use of new lung cancer treatments. The company will also distribute educational materials describing the first results from an important study showing that liquid biopsy testing using ICE COLD-PCR is concordant with established approaches, detecting as many or more of the relevant cancer mutations than either tumor tissue testing or liquid biopsy testing using conventional methods.

Transgenomic President and CEO Paul Kinnon commented, “The AACR Annual Meeting provides us the opportunity to communicate the advantages of our ICE COLD-PCR technology to leading oncology researchers and practitioners from around the globe. We are excited to share the first results from our studies showing high concordance between ICE COLD-PCR-based liquid biopsy results and tissue-based results from the same patients, along with its superior performance compared to liquid biopsy results produced using conventional PCR methods. We are currently further validating and extending these encouraging findings and expect to present additional data in peer reviewed scientific settings in the coming months.”

At the AACR meeting, Transgenomic is distributing an educational study report, “Multiplexed ICE COLD-PCR Provides High Concordance in Clinical Testing,” which describes the results of a concordance study assessing the ability of its Multiplexed ICE COLD-PCR (MX-ICP) technology to detect a key tumor mutation in matched plasma samples compared to detection in the same patients using tissue samples and plasma samples analyzed using conventional PCR methods. The study included 22 patients with late stage colorectal cancer. Use of MX-ICP-powered testing resulted in an 83% concordance rate between mutation positive tissue and plasma samples, compared to a concordance rate of 58% using conventional PCR. Taking into account all samples, the concordance for MX-ICP was 91% vs. 77% for traditional PCR. This high concordance rate supports the clinical validity and utility of MX-ICP-based liquid biopsies for cancer patient mutation detection and monitoring.

Mr. Kinnon added, “In addition, the two advanced EGFR tests for lung cancer highlighted in our AACR poster illustrate the power of ICE COLD PCR’s very high sensitivity, as well as our ability to rapidly produce new biomarker assays in response to emerging new knowledge and therapeutic approaches.”

In its AACR presentation, Transgenomic describes its two advanced assays for the detection of EGFR mutations associated with resistance to tyrosine kinase inhibitor (TKI) drugs for the treatment of non-small cell lung cancer (NSCLC). Accurate detection to promptly identify NSCLC patients who have developed resistance to their TKI therapy is essential for best practice treatment. Transgenomic’s high sensitivity EGFR T790M assay detects mutations associated with resistance to 1st generation TKI drugs such as Tarceva®, while its EGFR C797S assay detects mutations associated with resistance to new 3rd generation TKI therapies. Importantly, ICP technology allows both mutations to be detected using a single plasma or serum patient sample. The authors conclude that Transgenomic’s liquid biopsy EGFR assays may provide a highly sensitive, simple and cost effective tool for monitoring the emergence of acquired resistance to TKI therapy, potentially contributing to therapeutic optimization in clinical trials and ultimately, during ongoing treatment for lung cancer.

Transgenomic’s presentation #1390, “High sensitivity detection of EGFR exon 20 T790M and C797S mutations using ICE COLD-PCR,” Section 21, Poster Board #21, will be presented on April 18, 2016 from 8:00am to 12:00pm CT at the AACR 2016 Annual Meeting in New Orleans, LA.

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.

For more information about Transgenomic’s EGFR assays and its Biomarker Discovery Services, click here.

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-PCR™. Transgenomic also provides specialized clinical and research services to biopharmaceutical companies developing targeted therapies. 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, 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.

 

Contacts:

Media:                                                                         

BLL Partners LLC

Barbara Lindheim

212-584-2276                                                                  

blindheim@bllbiopartners.com

Investors:

Transgenomic Investor Relations

investor.relations@transgenomic.com