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Companion Diagnostics Come Of Age

The US companion diagnostics sector is predicted to grow from $1.6 billion to $6.2 billion between 2015 and 2021, a CAGR of 25.3%, outpacing the IVD market growth fivefold. This rapid growth will be driven by the development of new targeted pharmaceutical products and moves by the FDA to quickly approve new treatments and diagnostics together.

It is barely 20 years since the term "companion diagnostic" entered into the vocabulary of diagnostic and pharmaceutical companies. Yet in that short time, spurred by the findings of the Human Genome Project, commercial companion diagnostics (CDx) have become a reality, and new developments in the sector have become commonplace. As of the end of 2014, the US FDA had cleared or approved 20 companion diagnostic devices (in vitro and imaging tools), all but one of them for use in oncology.

One of the most recent developments in this sector came towards the end of 2014 when AstraZeneca PLC’s MedImmune LLC subsidiary acquired the privately owned tumor biomarker company...

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