Zelboraf + BRAF Mutation Assay

Disease: Metastatic Melanoma

About the Disease:

When melanoma is diagnosed early, it is generally a curable disease, however, when it spreads to other parts of the body, it is the deadliest and most aggressive form of skin cancer. The BRAF protein is a key component of the RAS-RAF pathway involved in normal cell growth and survival. Mutations that keep the BRAF protein in an active state and leads to uncontrolled cell growth and survival. These mutations of the BRAF protein are thought to occur in an estimated half of all melanomas and 8% of solid tumors.

What makes it unique:

It was the first and only personalized medicine shown to help patients with BRAF V600E Mutation-Positive Metastatic Melanoma, live longer, reducing the risk of dying by 56% in patients whose cancer had the genetic mutation. Zelboraf and its companion diagnostic test demonstrated significant advances in our understanding of the pathology of diseases and exemplified the benefits of developing personalized medicines for patients. It also marked the first case of having a co-development and approval of a diagnostic assay for the mutation, which was later used as an example for the FDA when they developed their guidelines for the industry as a whole.

Companion Diagnostic:

BRAF Mutation Assay. The cobas 4800 BRAF V600 Mutation Test is a polymerase chain reaction-based diagnostic test that identifies tumors that carry the BRAF V600E mutation.