Written by Bill Finger, Managing Director, Kineticos

The promise of companion diagnostics is something we’ve all discussed at great lengths over the years. More recently, the challenges of turning that promise into a reality have become a more popular topic. Companies ranging from pharma / biotech to diagnostic companies to labs are all trying to crack the code, and find the next blockbuster while working through the labyrinth of regulatory and payer issues. A couple of recent events led me to share my thoughts.

Exact Sciences, a molecular diagnostics company focused primarily on colorectal cancer, recently announced they are abandoning their development of a lung cancer-screening assay with the University of Texas MD Anderson Cancer Center. According to FierceMedical Devices, high costs coupled with uncertainty of future recommendations by the US Preventative Services Task Force was perceived as too high of a risk to keep the project going. (Full Article)

On a much different note, NanoString, a provider of life science tools for molecular diagnostics, just announced their partnership with pharma giant Merck to develop a companion diagnostic for the Anti-PD-1 cancer therapy Keytruda (pembrolizumab). NanoString is responsible for developing, commercializing, and obtaining regulatory approval for the test, with up to $24 million in milestone payments. (Full Article)

I found myself discussing this very topic with one of my colleagues, who happens to be a senior executive from one of the largest diagnostic companies. When talking in confidence about the overall future of companion diagnostics, he confirmed that developing companion diagnostics is a very challenging endeavor.

Finding the right test on the best platform with solid performance data is not enough. Challenges with reimbursement, adoption, as well as access to the test, are major factors impacting their strategy and causing them to rethink their approach.

While the landscape is indeed difficult to navigate, it’s in the best interest of all companies involved, and more importantly, the patient to persevere through the challenges. Developing a strategy that engages all relevant parties (pharma / biotech, diagnostics, regulatory agencies, payers, key opinion leaders, community physicians, patient advocates, disease specific foundations, etc.) early in the process will help to steer clear of future challenges. Getting early input and frequent input throughout the process will help illuminate and navigate the hurdles, allowing for more time to focus on what’s most important – the patient.


Bill Finger, Managing Director of Kineticos’ Diagnostics Practice, brings 20 years of diagnostics and laboratory experience to the team.  His team is focused on helping diagnostic companies maximize their commercial potential at the corporate and product levels while ensuring companies operate in an efficient manner.

 Contact Bill

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