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History of Companion Diagnostics

companion-diagnostics (Demo)

Insight by: Debbie Lin

For any life science company or startup company co-developing a drug with a medical device/digital health technology can be extremely challenging. One just has to look to the history of companion diagnostics to view the road that lies ahead.

Valla et al.’s paper on the state of the art and new regulations of companion diagnostics (CDx) gives us a great window into the relevant opportunities, challenges, and issues of bringing a pill plus technology to market. The authors point to the fact that:

  • The FDA approved 57% of companion diagnostics tests in the last five years, before March 2021. The rest, 43%, were approved in the 17 years between 1998-2015.
  • They also found that the average post-approval delay in clinical uptake of a CDx for a targeted treatment can take up to 5 years.

What does this say about the probability of success of pill plus technologies?

I am encouraged that the increased rate of CDx approvals in the past five years signals a growing market appetite for pill plus technologies. Further, the FDA has made good strides recently to encourage innovation in medical devices and digital health through the FDA Breakthrough Devices Program and its guidance documents on digital health.

The data on average post-approval delays in clinical uptake, however, demonstrates that the probability of ultimate success is rather dismal. If we conduct a back-of-the-envelope calculation, from the start of co-development, the minimum time it would take for clinical uptake would be roughly 7 years.  This excludes the time for product refinement, piloting, and contracting (add another 2 years, minimum). A digital health/medical device startup company that is left standing without significant financial backing and patient investors after this process would be quite a miracle.

How do we solve this problem to pave the way for faster clinical uptake and more efficient life science/Pharma engagement? Not all digital health technologies are co-developed to come to market with a pill. Digital health technologies and companion diagnostics also vary; however, many of the same issues and challenges stand in the way of their commercial uptake. As digital health technologies become even more pervasive in our lives, this certainly encourages uptake. What other opportunities are there for faster adoption and what approaches are there to redesign our healthcare system to try, fail and adopt more efficiently?