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The Role Of Companion Diagnostics In Drug Development

By Diagnostics World Staff

March 16, 2018 | In a recent Diagnostics World survey, we queried researchers about how their companies view companion diagnostics. Nearly 75% of surveyed researchers—representing academic institutions, pharma, and biotech companies—believe that companion diagnostics are vital to personalized medicine, and the rest say that companion diagnostics are one of several important approaches to achieving personalized medicine.

It’s, therefore, unsurprising that drug developers are incorporating companion diagnostics into their development pipelines.

Three-quarters of surveyed researchers say it takes one to three years to develop a companion diagnostic test, and the majority of the researchers surveyed—79%—prefer to work on developing both a drug candidate and its companion diagnostic at the same. Nearly all of the rest of the researchers like to begin work on diagnostics as a drug candidate is entering phase 3 trials.

Developing both a candidate and a diagnostic can be challenging and expensive. About 30% of survey respondents choose to work with a diagnostics partner to design the companion diagnostic while the drug candidate is being developed. The outsourcing approach helps streamline the development process for both the drug candidate and the diagnostic while also bringing needed diagnostic expertise to the table as well, researchers said. About a third of researchers who have outsourced diagnostic development reported that outsourcing is more cost efficient as well.

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But everyone isn’t onboard with outsourcing. More than half of the researchers surveyed said they are not currently working with a third party, though 33% of those would be open to outsourcing in the future.

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For most of the surveyed researchers, companion diagnostics are an important part of the future of drug development: 82% believe that companion diagnostics and personalized medicine will lead to significantly improved patient care.