Companion diagnostics, tests required to identify patients eligible for a specific targeted therapy, are typically discussed as a regulatory and clinical development requirement, but the commercial strategy surrounding diagnostic partnerships and reimbursement carries its own set of decisions that meaningfully affect how successfully a targeted therapy actually reaches its intended patient population.
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Diagnostic partnership structure varies considerably across companies, from exclusive partnerships with a single diagnostic manufacturer to open, multi-vendor approaches that allow several validated testing platforms to serve as the companion diagnostic. Exclusive partnerships can simplify coordination and quality control but risk limiting testing access in regions or healthcare settings where the exclusive partner lacks established laboratory relationships.
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Reimbursement for the diagnostic test itself, separate from reimbursement for the therapy, has historically lagged behind therapy-side reimbursement negotiations in many markets, creating a practical access gap where a physician may have coverage clarity for the treatment itself while facing genuine uncertainty about whether the required diagnostic test will be reimbursed, a gap that can meaningfully slow real-world adoption even after formal approval.
Physician and pathology lab awareness represents an underappreciated commercial variable, since ordering the correct companion diagnostic test requires physicians to recognize when a patient’s clinical presentation warrants biomarker testing in the first place, and testing rates for many biomarker-driven therapies have shown to lag well behind the eligible patient population simply due to inconsistent testing practice patterns across different care settings.
Turnaround time for diagnostic results directly affects therapy uptake in time-sensitive clinical situations, and companies have increasingly worked to support faster, more decentralized testing options specifically to reduce the gap between a patient’s diagnosis and the point at which biomarker status is confirmed and appropriate treatment can begin.
Coverage examining how specific companies have structured diagnostic partnerships and addressed testing rate gaps for their targeted therapies, such as the analysis published by The Pharma Vanguard, gives companies developing their own biomarker-driven products a more practical view of the commercial infrastructure required beyond the regulatory approval itself.