Roche diagnostic unit partnering with drugmaker on companion diagnostic

Ventana Medical Systems, a diagnostic company owned by Roche, signed an agreement to develop and commercialize a companion diagnostic for use with an experimental pancreatic cancer drug being developed by Halozyme Therapeutics.

The assay will be designed to test for high levels of hyaluronan (HA), a type of sugar that can accumulate around cancer cells. Halozyme's drug, PEGPH20, is being tested with two older drugs to treat patients with metastatic pancreatic cancer and high HA levels. A Phase-III trial is expected to begin next year. The drug received an orphan-drug designation in October and Fast-Track status in September.

An increasing number of cancer treatments are being developed alongside a companion diagnostic (CDx), and more of these assays are being used to identify which patients will respond to certain treatments. A recent report from IMS Health estimated that one-third of the oncology therapeutics approved over the last decade had a biomarker or CDx on label for any indication, and that this share has remained constant over that time.

Earlier this month Roche's Cobras Kras Mutation Test was approved by the FDA, which has approved or cleared 21 companion diagnostics. Patients with advanced colorectal cancer who do not have the Kras genetic mutation are more likely to benefit from drugs such as Eli Lilly's Erbitux and Amgen's Vectibix than those who do have the mutation.