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The Complete Guide to Companion Diagnostics: Market Environment Products and Companies
Date:12/12/2012

ts for pharma: improving clinical trial results and supporting new applications
Limiting the patient population based on genomic analysis with companion diagnostics can improve clinical trial data for a new drug and strengthen the case for regulatory approvals for use in targeted patient populations. This use of biomarkers to enhance trial results is expected to become the norm rather than the exception and may expand the use of the product by seeking a higher level of regulatory approval.



Furthermore, the use of companion diagnostics may reinvigorate interest in the back file of products that failed to jump regulatory hurdles related to efficacy in larger patient populations if it can be proven that specific patient subsets would benefit.



Benefits for payers: more assurance that money will be well spent
With a couple of notable exceptions, the rise of targeted therapies has been hampered by their relatively poor improvements in real-world therapeutic benefits relative to their sometimes eye-watering expense. The role played by pharmacoeconomics cannot be understated: health payers do not want to pay for expensive medicines unless there is confidence that the therapeutic benefit will be achieved. Companion diagnostics go a long way to providing that confidence by determining the appropriateness of a drug to a given disease state.


The challenge for regulators
The companion diagnostics market has grown very rapidly, and regulators have been running to catch up. Drug developers need clear guidance which sets out the regulatory bodies' expectations and standards for approval. So far, there has been little attempt by regulatory agencies to impose too many restrictions or enforce a parallel approval process. While this policy looks set to continue, however, we are already seeing an increase in companion diagnostic tests being stipulated as a requirement within the approval process and it may be inevitabl
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