Navigating funding and access challenges for biomarker strategies in precision medicine

As precision medicine advances, the success of biomarker strategies depends on both scientific innovation and overcoming market-specific funding and access barriers. There are steps pharma and diagnostics companies can take to navigate reimbursement frameworks, leverage laboratory-developed tests, and use temporary funding solutions to ensure timely and sustainable patient access.

Precision medicine has grown significantly as an area of interest and development for pharma and diagnostics companies over the past ten years, as evidenced by the number of FDA approvals for biomarkers tests as companion diagnostics (CDx). Before 2015, only 10 unique biomarkers were approved as companion diagnostics. Now, there are 38 approved biomarkers, primarily in oncological indications (e.g., HER2, BRCA1, ROS1, ESR1).

Pharma and diagnostics companies are continuing to invest in research and development of novel precision medicines that utilize a corresponding diagnostic…