ICE COLD-PCR-Based Breast Cancer Analysis Panel Detects Mutations in Actionable PIK3CA and AKT1 Genes from Blood Samples at Sensitivity Down to 0.01%; Results Available in 10 Days

 Visit Booth #1356 at AACR 2016 to Learn How ICE COLD-PCR’s High Sensitivity Enables Use of Liquid Biopsies for Cancer Mutation Detection and Monitoring                                    

 OMAHA, NE (April 19, 2016) — Transgenomic, Inc. (TBIO), (NASDAQ: TBIO), today announced that it is unveiling its new Breast Cancer Analysis Panel this week at the 2016 American Association for Cancer Research (AACR) Annual Meeting. The liquid biopsy test uses the company’s Multiplexed ICE COLD-PCR(MX-ICP) technology to detect tumor mutations from blood samples with high sensitivity down to 0.01%. The Breast Cancer Analysis Panel tests for mutations in certain actionable genes that are relevant to treatment decisions, including PIK3CA exons 9 and 20 and AKT1 (E17K) exon 4. Notably, results will be available in 7-10 days from TBIO, in contrast to turnaround times of up to four weeks for other testing methods.

Transgenomic President and CEO Paul Kinnon commented, “Metastatic breast cancer is a major killer of women, expected to cause almost 41,000 deaths in the US this year. Promising new breast cancer drugs include targeted therapies aimed at the PIK3CA and AKT1 genes that are mutated in about 30% of breast cancer patients. We are therefore very pleased to announce the imminent launch of our Breast Cancer Analysis Panel, which uses our unique Multiplexed ICE COLD-PCR technology to detect key mutations in these genes from an ordinary blood sample at very high sensitivity.”

Mr. Kinnon continued, “TBIO will deliver testing results to oncologists and their patients within 7-10 days, in contrast to the four-week turnaround typical of many other mutation tests. These rapid turnaround results may shorten the time to diagnosis and allow more informed treatment decisions, helping oncologists to select and initiate optimized treatment regimens for patients without delay. We look forward to receiving patient samples for the new panel at our Omaha CLIA testing laboratory at the beginning of May.”

There are multiple drug trials currently being conducted that target breast cancers with AKT1 or PIK3CA mutations. From a 10 mL blood sample, the Breast Cancer Analysis Panel is an ultra-sensitive method that provides amplified sensitivity for DNA mutation detection in breast cancer patients down to 0.01%. The Breast Cancer Analysis Panel supports determinations of when to start treatment and enables ongoing monitoring of treatment response. It uniquely determines mutational profiles of patients including both known and unknown mutations and is designed to detect actionable mutations even prior to visible tumor growth. TBIO will report testing results in 7–10 business days. Many other liquid biopsy technologies, including those based on next-generation sequencing, take up to four weeks to report testing results. The rapid turnaround time for the TBIO panel allows for prompt treatment changes, which can be critical when managing patients with metastatic breast cancer.

The company is also distributing an educational report at the AACR meeting, “Multiplexed ICE COLD-PCR Provides High Concordance in Clinical Testing,” which describes the results of a concordance study assessing the ability of MX-ICP technology to detect a key tumor mutation in plasma samples compared to detection in tissue samples and plasma samples analyzed using conventional methods. The study’s high concordance rate supports the clinical validity and utility of MX-ICP-based liquid biopsies for cancer patient mutation detection and monitoring.

In addition, TBIO hosted an AACR poster presentation yesterday discussing its advanced EGFR biomarker assays designed to help optimize the use of new lung cancer treatments, “High sensitivity detection of EGFR exon 20 T790M and C797S mutations using ICE COLD-PCR,” #1390.

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 TBIO’s clinical cancer mutation detection tests, click here.

About Transgenomic

Transgenomic, Inc. (TBIO) 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™. TBIO also provides specialized clinical and research services to biopharmaceutical companies developing targeted therapies. The company’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 14, 2016. 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.



BLL Partners LLC

Barbara Lindheim



Transgenomic Investor Relations