TBIO Telesis Bio Inc (PK)

Transgenomic, Inc. (OTCBB: TBIO) today announced that it has begun a collaboration with NYU Langone Medical Center to employ its ultra-high sensitivity ICE COLD-PCR mutation detection technology to better understand molecular events that drive non-small cell lung cancer and impact response to existing and novel therapies. The joint study will focus on the detection of cancer-associated mutations in the blood of patients with surgically operable early stage lung cancer, the stage where it is most curable and amenable to treatment.

Rare circulating tumor cells (CTCs) will be isolated from the blood of approximately 200 patients using Transgenomic’s licensed CTC capture ScreenCell® devices before and following surgery to determine if the numbers of CTCs change in response to treatment or are associated with disease recurrence or progression. DNA from these cells will be analyzed by ICE COLD-PCR for the presence of mutations that have been shown to affect response to targeted drugs; tumor-derived cell-free DNA (cfDNA) found in blood samples will be analyzed similarly. The molecular profile of cfDNA and DNA isolated from CTCs will then be compared to that of the primary lung tumor to better understand characteristics of cells that escape the tumor and are thought to be responsible for metastasis. Mutations conferring drug resistance can also be measured from CTCs and cfDNA and may indicate the re-emergence of disease before clinical symptoms appear, at a time when the administration of alternative therapies may forestall progression.

“Our ICE COLD-PCR technology is ideally suited to monitor patients’ disease activity and response to drugs in real time”, said Craig Tuttle, Chief Executive Officer of Transgenomic, Inc. “Detecting cancer mutations from CTCs and DNA present in blood samples will allow physicians to intervene before clinical symptoms of disease recurrence appear and make routine ‘blood biopsies’ a reality.”

The study will be jointly overseen by Dr. Harvey I. Pass, M.D., the Stephen E. Banner Professor of Thoracic Oncology and Vice-Chair Research, Department of Cardiothoracic Surgery and Division Chief, General Thoracic Surgery, NYU Langone Medical Center, and by Drs. Marcia Lewis, Vice President of Biomarker Development and Katherine Richardson, Vice President of R&D at Transgenomic, Inc. Transgenomic will provide funding for support staff at NYU Langone Medical Center for the duration of the study, which is estimated to take between one and two years.

“The NYU Langone Thoracic Oncology Laboratory is extremely excited about this collaboration, which was facilitated by the Early Detection Research Network of the NCI/NIH”, said Dr. Pass. “It will enable a greater understanding of the role of CTCs in early lung cancer in a prospectively accrued, large number of patients. Moreover, the ability to detect tumor-identical mutations in CTCs from lung cancer patients could open up a wealth of possibilities for non-invasively prescribing the appropriate therapy for the right patient, especially now when so many targetable mutations are being discovered in the disease.”

This study builds on Transgenomic’s recently announced collaboration at MD Anderson Cancer Center that also employs ICE COLD-PCR to characterize tumor-derived DNA in blood and DNA isolated from CTCs from patients with a variety of cancers to choose therapies shown to target specific mutations. Transgenomic is negotiating additional collaborations at major cancer centers in the US to extend the validation of its ICE COLD-PCR technology.

In June, the Company announced the commercial launch of its REVEAL® Kits which utilize ICE COLD-PCR to detect mutations in a variety of cancer-associated genes.

About ICE COLD-PCR

ICE COLD-PCR, "Improved and Complete Enrichment COamplification at Lower Denaturation” temperature, that Transgenomic has developed in collaboration with the laboratory of Mike Makrigiorgos at Dana Farber Cancer Institute, selectively amplifies mutant DNA by exploiting differences in denaturation temperatures between mutant DNA duplexes and normal “wild-type” DNA duplexes. These differences are extenuated by use of a reference oligonucleotide strand containing Locked Nucleic Acids that binds more tightly to the region of interest in normal DNA than in mutant DNA. PCR cycling parameters are set so that mutant DNA strands are amplified exponentially while normal DNA strands are amplified linearly, thus enriching the population for DNA targets containing the mutant sequence(s). Mutant-containing targets can then be analyzed by Sanger sequencing utilizing standard equipment, or by other sequence analysis methods. ICE COLD-PCR is able to detect mutant DNAs occurring in as low as 0.01% frequency in a majority of wild-type (normal) populations. In addition, the technique is not specific to a single mutation within a DNA target but enables detection of any mutation in a given region of DNA.

The approach allows clinicians to use small amounts of sample for genetic analysis or non-invasive sample collection methods such as a blood draw to enable detection of mutant DNA species present in serum or plasma, circulating tumor cells, urine, or bronchial lavage specimens. DNA can also be analyzed from fine needle aspirates, core-biopsies, or directly from tumors. Since ICE COLD-PCR can detect low level mutations in samples where an abundance of “normal” DNA exists, such as blood, repeated assessments of a patient’s disease status can be determined without having to take additional biopsies from the tumor.

About Transgenomic, Inc.

Transgenomic, Inc. (www.transgenomic.com) is a global biotechnology company advancing personalized medicine in cardiology, oncology, and inherited diseases through its proprietary molecular technologies and world-class clinical and research services. The Company is the global leader in cardiac genetic testing with a family of innovative products, including its flagship C-GAAP test, designed to detect gene mutations which indicate cardiac disorders, or which can lead to serious adverse events. Transgenomic has three complementary business divisions: Transgenomic Clinical Laboratories, which specializes in molecular diagnostics for cardiology, oncology, neurology, and mitochondrial disorders; Transgenomic Pharmacogenomic Services, a contract research laboratory that specializes in supporting all phases of pre-clinical and clinical trials for oncology drugs in development; and Transgenomic Diagnostic Tools, which produces equipment, reagents, and other consumables that empower clinical and research applications in molecular testing and cytogenetics. Transgenomic believes there is significant opportunity for continued growth across all three businesses by leveraging their synergistic capabilities, technologies, and expertise. The Company actively develops and acquires new technology and other intellectual property that strengthens its leadership in personalized medicine.

About ScreenCell

ScreenCell was founded with the objective of designing and producing a simple but revolutionary technique allowing the fast and effective filtering of Rare Circulating Cells yielding high-quality CTC population amenable to better cellular and molecular characterization. ScreenCell designed a full range of point of care devices for development for use in in vitro Diagnostics (IVD) assays and platforms. ScreenCell is dedicated to creating technologies allowing CTCs to become potential end points in future oncology therapeutic arsenals by filtering out healthy live tumor cells, thus enabling:

• molecular biology
• cell culture
• enumeration and cytomorphology evaluation

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. Forward-looking statements include, but are not limited to, those with respect to management's current views and estimates of future economic circumstances, industry conditions, company performance and financial results, including the ability of the Company to grow its involvement in the diagnostic products and services markets. 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.

Telesis Bio (PK) (USOTC:TBIO)
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