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| Fibroblast growth factor receptors (FGFRs)--Courtesy of Ventana |
Roche's ($RHHBY) Ventana Medical Systems announced a companion diagnostic agreement centered around Astellas Pharma's cancer-fighting ASP5878.
The Japanese company's oral Phase I candidate is a novel small-molecule fibroblast growth factor receptor (FGFR) that blocks the enzymatic activity of the FGFR1, FGFR2, FGFR3 and FGFR4 genes.
Ventana Medical Systems will develop an immunohistochemistry (IHC) test to identify the FGF19 protein in certain solid tumors, says the release announcing the agreement.
According to the National Institutes of Health's National Center for Biotechnology Information, "FGF family members possess broad mitogenic and cell survival activities, and are involved in a variety of biological processes including embryonic development cell growth, morphogenesis, tissue repair, tumor growth and invasion."
Fibroblasts are a common cell found in many connective tissues.
Companion diagnostics are the cornerstone of personalized medicine because they allow physicians to select individual patients for the treatment that suits them best based on unique, personalized factors such as genetic makeup or disease subtype. The FDA often requires personalized therapies to be approved in conjunction with a companion diagnostic that enables stratification based on a biomarker, in this case the presence of the FG19 protein in the cancerous tumor.
In turn, companies utilize companion diagnostics in their clinical trials to find and differentiate between patient subgroups. Sometimes they exclude patients without the specified biomarker from their trials in order to find the "signal" of efficacy within a certain population.
Ventana is also awaiting FDA approval for an IHC diagnostic for ALK-1 lung cancer, a version of the disease that contains hazardous protein produced by changes in the ALK gene.
Other recent companion diagnostic pacts include Myriad Genetics' ($MYGN) deal with AstraZeneca ($AZN) to test metastatic pancreatic cancer patients who may respond to the Big Pharma's Lynparza (olaparib), and Dako's alliance with biotech company Amgen ($AMGN), focused on an unnamed cancer drug.
- read the release