How To Capitalize On The Companion Diagnostics Boom
In this dawning era of personalized medicine, the ongoing development and adoption of companion diagnostics is exploding. These tests — which indicate whether or not a drug will be effective in a specific patient (or perhaps even harm them) — have been used in breast cancer applications for over a decade and are now being applied to other cancers as well. And with the ongoing discovery of new disease biomarkers, the indications for companion diagnostics are expanding quickly. In fact, according to a recent report published by Transparency Market Research, the global market for companion diagnostics is expected to reach $5.6 billion by 2019.
In this podcast, Med Device Online chief editor Jim Pomager interviews Michael Drues, Ph.D., consultant and author of the Guerilla Regulatory Strategies column series, about companion diagnostics, related regulations, and potential opportunities for medical device makers.
For More Information:
- FDA Draft Guidance [PDF]: Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs)
- FDA Guidance [PDF]: In Vitro Companion Diagnostic Devices
- Webinar: How To Take Advantage Of The Companion Diagnostics Opportunity (Nov. 13, 2014, 1:00 pm EST)
- Contact Michael Drues via email or on LinkedIn.
Music credit: Morning Blue (Instrumental) (Josh Woodward) / CC BY 3.0