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Halozyme, Ventana Team Up for CDx Development

NEW YORK (GenomeWeb) – Halozyme Therapeutics and Ventana Medical Systems, a Roche company, today announced a collaboration agreement to develop and commercialize a companion diagnostic assay for use with Halozyme's investigational new drug, PEGPH20.

Under the terms of the agreement, Ventana will develop an assay to identify high levels of hyaluronan (HA), a chain of sugars that can accumulate around cancer cells, using Halozyme's proprietary HA-binding protein. Ventana will ultimately be responsible for submitting the assay for regulatory approval in the US, Europe, and other countries as well as commercializing the assay.

Halozyme has announced plans for a global phase III clinical trial in 2016 to treat metastatic pancreatic cancer patients with high HA levels using PEGPH20 in combination with Abraxane and gemcitabine.

The assay could be the first companion diagnostic assay for pancreatic cancer, Ventana Companion Diagnostics VP Doug Ward said in a statement.

Financial details of the agreement were not disclosed.

Last month Ventana signed a master collaboration agreement with Astellas to develop companion diagnostics for the Japanese drug maker. In January, Ventana completed a premarket approval application with the US Food and Drug Administration for an ALK companion diagnostic, but did not disclose its drug partner.