The recent advances in companion diagnostics facilitate the practice of precision medicine, identifying which patients are most likely to respond favorably to particular therapies. Diagnostic companies, CROs and commercial laboratories have become essential to the pharma, biotech, and medical technology industries by supporting clients’ efforts to test, refine, and market the latest pharmaceuticals and medical devices.

The expansion of companion diagnostics will also have a global component as markets in Europe will evolve in a similar but not identical pattern as the US.

The greatest challenge to future growth in companion diagnostics is aligning the incentives of all stakeholders. A major driver of growth will continue to be the economic incentives for drug developers to pair their products with diagnostics. However, diagnostic companies, CROs and commercial laboratories are caught between the conflicting demands of pharmaceutical companies on one hand and payers/providers on the other.

Since the economics of companion diagnostic deals are rarely disclosed, most if...

Summary

A biomarker is a defined molecular characteristic, for example a genetic mutation, that can tell a physician more about a patient’s disease state, or how they might respond to treatment. Predictive biomarkers indicate how likely a patient is to respond to a treatment, and are used in clinical decision making. In some cases, a patient must possess a particular biomarker to receive a particular drug. For example, breast cancer patients must test positive for HER2 in order to receive anti-HER2 therapy. Companion diagnostics (CDx) are in vitro diagnostics used to measure biomarkers deemed essential for the use of a particular drug, and their use is on the rise, particularly in oncology. In fact, over 90% of FDA-approved CDx are for cancer indications. This is likely because oncology treatments have a relatively high ‘failure’ rate compared to other diseases, and treating a patient with the right drug is often very time-sensitive due to the aggressive nature of some cancers. Biomarkers are of high interest to multiple stakeholders in oncology and have been a...