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Transgenomic Strikes Pair of Distribution Deals for Mutation Detection, CTC Analysis

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This article has been updated from a version posted Nov. 7 to include information about a second distribution agreement.

Transgenomic this week announced a pair of distribution agreements in the areas of mutation detection and circulating tumor cell isolation and analysis.

First, Transgenomic said that Florence, Italy-based A. Menarini Diagnostics will exclusively distribute Transgenomic's mutation-detection system, including its Surveyor Scan and Wave MCE (micro-capillary electrophoresis) technologies, to A. Menarini's network of more than 2,000 pathologists in Europe.

Transgenomic's Surveyor Scan technology uses a PCR amplification reaction and hybridization to form mispaired DNA molecules where there are mutations. A digestion step is then performed using Surveyor nuclease, which cuts the DNA strands at these mismatched base pairs. The different sized pieces of DNA can then be differentiated from non-mutant DNA using Transgenomic's Wave system, which is based on denaturing high-pressure liquid chromatography.

Transgenomic, based in Omaha, Neb., has developed Surveyor-based mutation-detection kits for cancer genes such as KRAS, BRAF and PI-3 kinase for its Wave systems. Earlier this year, the company began developing versions of its kits for the Wave MCE, "a faster, lower-cost system which has exhibited equivalent analytic sensitivity to the Wave and better analytic sensitivity than competitive technologies typically used for this testing," Transgenomic CEO Craig Tuttle said in a statement.

"Surveyor Scan and the Wave MCE platform bring a simple but powerful solution to pathologists looking to offer a molecular pathology service," Crescenzio Isso, general manager of A. Menarini Diagnostics, said in a statement.

Isso added that A. Menarini Diagnostics will also eventually distribute in Europe Transgenomic's Ice Cold-PCR technology, which is still under development.

"Improved and complete enrichment," or Ice Cold-PCR, is an improved version of Transgenomic's "coamplification at lower denaturation temperature," or Cold-PCR technology, a mutation-detection technology that recognizes mutant DNA strands that denature at lower temperatures in a PCR reaction than normal DNA strands.

Transgenomic has an exclusive license from the Dana-Farber Cancer Institute to analyze Ice Cold-PCR products using pyrosequencing and Sanger sequencing, and for mitochondrial DNA analysis.

In the second agreement announced this week, Transgenomic and Paris-based ScreenCell said they have signed a perpetual, worldwide, collaboration and distribution agreement for ScreenCell's isolation devices and dilution buffers for the collection of circulating tumor cells in peripheral blood.

Specific terms of that agreement call for Transgenomic to exclusively distribute ScreenCell's technologies in combination with its own Blocker-Sequencing cancer mutation assays, Surveyor Scan cancer mutation kits, and Wave instrument systems; and eventually with its Ice Cold-PCR assays.

"This agreement is an important marriage of technologies, one designed to isolate rare cells of potentially significant prognostic value in cancer, and another, our Ice-Cold PCR, designed to enrich mutations to levels that can be detected even in small CTC cell loads and amidst competing wild-type DNA," Tuttle said in a statement.

Transgenomic said that it expects to begin selling ScreenCell products immediately in combination with its products as part of a pharmacogenomics services offering and for other non-exclusive broad research applications to drug developers and academic researchers.

The companies have also agreed to co-develop technologies that have thus far been tested in a proof-of-concept study at Dana Farber. Transgenomic and ScreenCell said they also plan to conduct additional validation efforts with Dana Farber and other research institutions.