Companion Diagnostics

A Companion Diagnostic (CDx) is a medical device that provides information that is essential for the safe and effective use of a corresponding drug or biological product. Upon starting a CDx program and throughout development of the assay, Insight Genetics will work with your team to ensure this process runs smoothly and swiftly, managing alignment with development of the therapeutic. All CDx assays are designed according to Insight Genetics' strict Quality Standards.

Working with Insight Genetics:

Initiating a CDx program begins with generating an FDA project plan and initial discussions with the FDA to ensure communication throughout the clinical trial process, under the recently finalized FDA guidance. Insight Genetics facilitates the coordination of the key components for each client’s specific CDx program through our internal capabilities and preferred partners.

Biomarker-driven patient enrollment can help significantly shorten timelines, moving the entire drug development process from Phase I to Market in less than 5 years.

Using the Companion Diagnostic as a compass to guide drugs through development on targeted patient populations significantly increases success rates. In fact, a study published in 2013 shows a 50% increase in successful Phase III clinical trials using a biomarker approach to enroll the correct patient population.