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Transgenomic Inks Second Pact to Evaluate Ice-Cold-PCR for Blood-Based Cancer Mutation Detection

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Transgenomic this week announced its second collaboration with a university medical center to evaluate the use of its Ice-Cold-PCR technology for blood-based mutation detection in cancer.

The Omaha, Neb.-based company said that it is collaborating with New York University's Langone Medical Center to use Ice-Cold-PCR to study the molecular basis of non-small cell lung cancer and therapeutic response to existing and novel NSCLC therapies.

Under the partnership, researchers from Transgenomic and NYU-Langone will isolate rare circulating tumor cells from the blood of approximately 200 patients using Transgenomic's ScreenCell CTC-capture devices before and following surgery to determine if the CTC numbers change in response to treatment or are associated with disease recurrence or progression.

The group will then analyze DNA from these cells using Transgenomic's "improved and complete enrichment coamplification at lower denaturation temperature," or Ice-Cold-PCR, technology, for the presence of mutations that have been shown to affect response to targeted drugs. The group will similarly analyze tumor-derived cell-free DNA from blood samples.

The researchers will then compare the molecular profile of cfDNA and DNA isolated from CTCs to that of the primary lung tumor to better understand the characteristics of cells that escape the tumor and are thought to be responsible for metastasis, Transgenomic said.

Transgenomic will provide an unspecified amount of funding for support staff at NYU-Langone for the duration of the study, which is estimated to take between one and two years.

Harvey Pass, professor of thoracic oncology and vice chair of research in the department of cardiothoracic surgery and chief of the general thoracic surgery division at NYU-Langone, will oversee the study from the NYU side. Pass noted in a statement that the partnership "will enable a greater understanding of the role of CTCs in early lung cancer in a prospectively accrued large number of patients."

Ice-Cold-PCR builds on Cold-PCR technology, which selectively amplifies mutant DNA by recognizing that mutant DNA strands denature at lower temperatures in a PCR reaction than normal DNA strands. The Ice Cold-PCR methodology further enhances this sensitivity by using Exiqon's Locked Nucleic Acid technology and a reference strand that binds PCR amplicons to form duplexes that are preferentially denatured and amplified at a certain temperature.

The mutant amplicons can then be analyzed using various sequencing methods. Transgenomic has an exclusive license from Dana-Farber to analyze Ice-Cold-PCR products using pyrosequencing and Sanger sequencing.

In March, Transgenomic said that it had initiated a collaboration with the University of Texas MD Anderson Cancer Center to evaluate the use of Ice-Cold-PCR to analyze DNA isolated from circulating tumor cells in blood samples from patients with advanced cancer, though it didn't disclose the cancer type (PCR Insider, 3/22/2012).

In addition, Transgenomic has initiated work under a Phase I Small Business Technology Transfer grant from the National Institutes of Health to study the feasibility of using Ice-Cold-PCR for the early detection of pancreatic cancer using mouse models (PCR Insider, 8/16/2012).

To better enable these studies, Transgenomic inked an exclusive distribution and co-marketing agreement in November with Paris-based ScreenCell for its isolation devices and dilution buffers for collecting circulating tumor cells in peripheral blood (PCR Insider, 11/10/2011).

"Our Ice-Cold-PCR technology is ideally suited to monitor patients' disease activity and response to drugs in real time," Transgenomic CEO Craig Tuttle said in a statement this week. Tuttle added that the ability to detect 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."

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