Case Studies

DBH partnered with DiaCarta, a diagnostics company, to navigate the CMS 2025 Clinical Lab Fee Schedule process for its prostate cancer test (CPT 0497U). Despite strong advisory panel support for CPT 0047U, CMS initially proposed a less favorable crosswalk. DBH provided expert market access strategy, submitting comprehensive evidence, proposing strategic alternatives, and engaging CMS effectively. Their advocacy secured the preferred crosswalk, ensuring appropriate reimbursement and reinforcing the impact of expert-led market access strategies.

We collaborated over an extended period with a leading Fortune 50 pharmaceutical company for the launch of a molecular point-of-care in vitro diagnostic test. This test was specifically developed for the differential diagnosis of COVID-19 and influenza A/B, aiming to streamline and improve diagnostic accuracy at the point of care. It was considered a high-priority for the client, with enterprise-wide implications.

DBH collaborated with a pre-Series A (startup) digital pathology company that had created an AI-based SaMD, capable of predicting cancer genomic biomarkers and informing the prescription of precision therapeutics. The company was at a critical point, transitioning from an emphasis on research and development, to market access and commercialization. DBH was asked to advise the client while turning this corner, to ensure that their unique product would be well positioned in the marketplace.

DBH collaborated with a diversified Fortune 500 life sciences company, analyzing real-world data in a partner US research institute to inform competitive positioning, reimbursement, and widespread provider adoption. The client’s product was a molecular diagnostic panel that was FDA approved for emergency use, with client plans for broader access.