Roche announces Ambry Genetics as first US CSP for NimbleGen SeqCap EZ Exome workflow

February 22, 2016

The company now is working in collaboration with Roche to develop a companion diagnostic test that will help identify patients with what is called the BRAF mutation. These patients are the most likely to benefit from the compound. Plexxikon's drug, which is being co-developed by Roche, only works in the 50 to 60 percent of melanoma patients who have a specific mutation of the BRAF gene.The U.S. Food and Drug Administration is looking at the evidence to approve and validate such diagnostic tests. ???We think this might be the first example where the therapy and the diagnostic go to the FDA at the same time,??? Bollag said.

According to Kathleen Glaub, Plexxikon's president, similar research is on towards developing another compound that can treat cancers that have spread to the bone, including breast cancer. ???I think all of us in this industry have to figure out different ways to develop drugs that are more efficient and enable us to move development faster,??? said Ms Glaub. She added that the company expects to present results of its phase 2 study in November at an international melanoma conference.

According to Bollag, the company would embark on a clinical trial that will combine PLX4032 with a Roche drug called GDC-0973 that interferes with the MEK signaling pathway, which is also attacked by PLX4032.