Biopharmaceutical companies continue to adopt personalized medicine approaches that leverage patient-specific biomarkers to stratify patients. Companion diagnostic (CDx) tests are indispensable to personalized medicine, which relies on accurate, reliable, and clinically meaningful tests to identify the appropriate drugs for each patient.

The commercialization of these tests raises challenges for biopharmaceutical companies, which strive to provide patients access to drugs. Biopharmaceutical companies typically partner with global in vitro diagnostic (IVD) companies to complete the steps that lead to a successful CDx test:

  • Development
  • Regulatory approval (often sought during the drug’s pivotal trial), commercialization
  • Widespread distribution into laboratories.

Local or central laboratories often process collected samples, perform the tests (from the IVD partner) and report test results back to physicians. Laboratories might also create their own “homebrews” or laboratory-developed tests (LDTs), to reduce input costs.

This Executive Insights examines issues involving test ordering, test performance and results reporting, and identifies potential strategies that biopharma companies should consider to minimize patient leakage and maximize access to drugs with CDx.

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