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Trovagene, Boreal Genomics to Co-Develop Kits for ctDNA Analysis

NEW YORK (GenomeWeb) – Trovagene and Boreal Genomics said today that they have agreed to merge their respective technologies in order to co-develop assay kits for the detection and analysis of circulating tumor DNA in urine and blood, which they plan to launch in 2017.

The companies have each contributed proprietary technology and methods to developing simple, routine, and low-cost urine and blood ctDNA assays for next-generation sequencing platforms. The partners hope that these assays can address an unmet need for tests that fill the gap between single-gene PCR assays and expensive, broad sequencing assays.

As part of the deal, Trovagene has committed to pay $1 million in upfront and milestone payments in exchange for global distribution and sub-distribution rights for blood-based assays and exclusive distribution rights for urine-based assays for at least 10 years.

"Trovagene's unique expertise in assay design for applications in urine, coupled with Boreal's unique ctDNA enrichment technology, have created an immensely powerful tool for translational research, diagnostics, and future early detection of disease," Boreal Genomics President and CSO Andre Marziali said in a statement.

The kits are intended for clinical research, and the first panels will cover the National Comprehensive Cancer Network's list of clinically actionable mutations for which there are targeted therapies or treatment options available.

Trovagene and Boreal will work together to have the kits and systems manufactured in a cGMP facility, and to take them through the regulatory processes of the US Food and Drug Administration and other agencies.

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