(TBIO) Launches Multiplexed ICE COLD-PCR™ Enabled EGFR CLIA Test

Transgenomic, Inc. (NASDAQ:TBIO) today announced the launch of its new Multiplexed ICE COLD-PCR™ (MX-ICP) CLIA service for mutation detection in cancer patients to enable more informed diagnoses, better treatment decisions and ongoing patient monitoring. The service leverages the ultra-high sensitivity of Transgenomic’s proprietary MX-ICP technology to deliver highly accurate results from almost any type of patient sample. The first tests are for the detection of EGFR exon 20 T790M mutations that affect the utility of tyrosine kinase inhibitor (TKI) drugs used for non-small cell lung cancer and EGFR exon 12 S492R mutations that render colorectal cancer patients resistant to the widely-used drug cetuximab. Transgenomic intends to add additional single mutation and mutation panel detection tests to its suite of testing services in the coming months.

Bruce E. Johnson, MD, Chief Clinical Research Officer, Dana Farber Cancer Institute and Professor of Medicine, Harvard Medical School, noted, “The development of an accurate means to detect EGFR T790M with a blood test is an important development for our patients. We anticipate different drugs will be approved later this year for patients with acquired resistance to EGFR-TKIs and the presence of T790M in their tumor. Approximately 30% of our patients at the time of progression on EGFR-TKIs are unable to be biopsied, so an alternative means of testing using a blood-based test for assessing their status will be critical for this subset of EGFR-mutant NSCLC patients.”

“Launching our Multiplexed ICE COLD-PCR-based CLIA mutation detection service for oncologists and their patients is a major milestone for Transgenomic and, we believe, an important advance for the field of precision medicine,” said Paul Kinnon, President and Chief Executive Officer of Transgenomic. “The unsurpassed accuracy of MX-ICP and its ability to produce highly sensitive and accurate results from small amounts of almost any type of patient sample, especially liquid biopsies, allows broad use. This will enable far more patients to benefit from therapy optimized for their specific cancer and the insights into disease and treatment status obtained from ongoing monitoring during therapy, unlike currently-used tissue biopsies. Our first two tests focus on common treatment-relevant mutations in lung and colon cancer, and we intend to add new tests and test panels for other mutations and additional cancers in the coming months.”

Multiplexed ICE COLD-PCR achieves its ultra-high sensitivity by preferentially enriching the scarce mutant DNA sequences present in an ocean of wild-type (normal) DNA through selective amplification of the 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–down to 0.01% from as little as 4-5 ml of plasma sample, making it possible to obtain accurate and sensitive biopsies using either liquid or solid tissue specimens. ICE COLD-PCR 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.

The new service will accept a wide range of patient samples, including tissue, plasma, fine needle aspiration, bronchoscopy, cytology and other body fluid samples. Actionable results will be available in 7-10 working days. Additional tests and panels for mutations in EGFR, KRAS, NRAS, PIK3CA, BRAF and other genes are currently in development.

Transgenomic also announced the publication and availability of a study abstract at the 2015 ASCO Annual Meeting website and at our booth confirming the clinical utility of expanded screening of KRAS and NRAS genes in colorectal cancer patients using Transgenomic’s CRC RAScan™ test.¹

KRAS and NRAS mutations are found in approximately one-quarter of human tumors. They lead to activation of RAS family genes that play a critical role in determining response to EGFR mutation-targeted therapies such as cetuximab and panitumumab. Presence of KRAS exon 2 mutation status has been used as a key predictor of response to anti-EGFR therapy. However, about 10% of patient tumors that do not have a mutation in KRAS exon 2 have been found to have mutations in KRAS exons 3 or 4 or in NRAS exons 2, 3, or 4, which also respond poorly to anti-EGFR treatment. Evaluation of colorectal cancer cases tested in Transgenomic’s laboratory facility identified almost one-quarter with these mutations. Of these, 45% had the expected mutation in KRAS exon 2, but the other 55% had mutations in KRAS exon 3 or 4, or in NRAS exon 2 and 3. These findings suggest that screening for mutations in these other gene regions could play an important role in improved management of colorectal cancer. The authors conclude that the study results confirm that using the CRC RAScan test as a screen ensured the more effective use of anti-EGFR therapies for individuals with metastatic colorectal cancer.

For more information on Transgenomic’s CLIA services for KRAS and NRAS testing, click here. For more information on its EGFR CLIA tests, click here.

¹ Clinical utility of expanded screening of the KRAS and NRAS genes for Metastatic Colorectal Cancer: Evaluation of the CRC RAScan tumor test as a companion diagnostic to determine efficacy of anti-EGFR therapies. KA Richardson, S Peterson, J Bevilacqua, S Veys, V Rosendale, BL Legendre, KC Bible, H Reddi; Abstract No: e12554J; Clin Oncol 33, 2015 (suppl; abstr e12554)

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™ 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.