Written by Bill Finger, Executive Vice President & Managing Director, Kineticos

Since I last touched on how popular the companion diagnostics space is becoming, I have continued to see an abundance of stories come across my news feeds indicating sustainable growth in this area. Both big and small players are forming partnerships as well as getting regulatory approval for novel assays so I don’t anticipate a shift away from CDx any time soon, if ever.

In March, HTG Molecular was granted CE marking in Europe for their HTG EdgeSeq ALKPlus assay, a next-generation sequencing assay that measures mRNA ALK gene rearrangements in lung tumor specimens that is used to identify patients that may benefit from ALK-targeted therapeutics.

On the deal front, Myriad Genetics and BeiGene announced an agreement to develop assays that support BeiGene’s clinical development program. It was stated that BeiGene will use Myriad’s myChoice HRD and BRACAnalysis companion diagnostics in support of its investigational PARP inhibitor BGB-290. Myriad has also inked CDx deals with four other firms so they are clearly committed to the space.

Another recent example is Thermo Fisher Scientific collaborating with the University Hospital Basel to develop their next-generation sequencing-based Oncomine portfolio. The Oncomine assay is designed for genetic analysis based on their Ion AmpliSeq technology and the goal of the collaboration is to accelerate clinical trial enrollment and develop novel solutions supporting hospitals and patients.

Clearly, the market has a continued focus on CDx and understands the potential of targeting therapies to specific patients. It’s an easy decision for the drug manufacturers because if they are able to effectively segment patients that will benefit from their drug, it will allow them to focus their efforts on particular patients and the physicians treating them. Additionally, pharmaceutical companies are motivated to find diagnostic partners to develop companion diagnostic tests because influencers such as the FDA and payers/providers are strongly supporting a move in this direction. From a diagnostic company’s perspective, all of this serves as motivation to identify pharmaceutical partners that can benefit from their technology.

Companies are beginning to learn from past successes and failures and it appears as if the market dynamics of CDx are becoming more clear as time passes. For larger companies that have dedicated resources to executing a companion diagnostic strategy, it may not look nearly as daunting as it did 5 years ago. For companies with limited resources, developing a strategy that carefully considers the market, the customer, and competing technologies will help lead to a clearer tactical plan to approach the market.

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Bill Finger, Executive Vice President & 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