Trovagene Inc, San Diego, has entered into a long-term supply and distribution agreement with Boreal Genomics, Vancouver, BC, Canada, merging their respective technologies to codevelop urine and blood circulating tumor DNA (ctDNA) assay kits.
Through the partnership, the companies intend to provide a simple, routine, and low-cost urine and blood ctDNA assay for next-generation sequencing platforms. Trovagene and Boreal have each contributed proprietary technology and methods to enhance ctDNA detection capabilities from urine and blood to develop a series of cancer-specific multigene panels planned for launch in 2017.
Initially, the panels will be designed to cover National Comprehensive Cancer Network (NCCN) listed clinically actionable mutations for which there are targeted therapies or treatment options available. The partnership’s goal is to address a gap between single-gene polymerase chain reaction assays that can be limited by sample availability, and broad, multigene panels hindered by low clinical sensitivity for mutation detection.
The companies intend to develop additional panels throughout the partnership, and Trovagene plans to globally distribute the assay kits for use on the Boreal OnTarget system in blood and exclusively in urine. Trovagene’s initial research-use-only proprietary kits will include a urine collection kit, a urine extraction kit, and a mutation enrichment kit, along with the Boreal OnTarget system.
Bill Welch, Trovagene.
“We are excited to partner with Boreal to be able to reach oncology professionals and their patients on a global basis through the distribution of our kits and systems,” says Bill Welch, CEO of Trovagene. “Our commitment continues to focus on democratizing cancer care by harnessing urine and changing the landscape of the liquid biopsy market.”
Andre Marziali, PhD, Boreal Genomics.
“We’re thrilled to be able to partner with Trovagene to build these exciting technologies using our OnTarget platform,” says Andre Marziali, PhD, president and chief scientific officer of Boreal Genomics. “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.”
Under terms of the agreement, Trovagene will commit upfront and milestone payments totaling $1 million. Furthermore, Trovagene has global distribution and subdistribution rights in blood and exclusively in urine for at least 10 years. The companies will work together to have the kits and systems manufactured in a cGMP facility, and to take them through FDA, CE mark, CFDA, and other regulatory approval pathways.
For more information, visit Boreal Genomics and Trovagene.
