Biomarker Development Program

Share
Share
Cancer cells

Image of cancer cells courtesy of Science Source.

MSK’s Biomarker Development Program aims to accelerate the development and approval of biomarker assays and technologies.

Memorial Sloan Kettering Cancer Center’s Biomarker Development Program (BDP) is a translational research program that aims to accelerate the development and approval of biomarker assays and technologies. These rapidly evolving tools, which can be used for a range of cancer types, enable more informed medical decision-making. They also allow clinicians to take great strides forward in addressing obstacles to optimized patient care, including late diagnosis of disease, inability to select the best treatment for each individual patient’s tumor, and delays in translating therapeutic innovations from the laboratory (bench) to clinical practice (bedside).

To address these challenges, the BDP plans to effectively change the paradigm of collaborative biomarker development. Our approach is to treat the development of a biomarker the same way we do the development of a drug, which requires that each device or assay is “fit for the purpose” in which it will be studied, followed by the sequence of clinical trials to support and justify regulatory approvals and coverage by third-party payers. These steps are essential to ensure that the biomarker test can be used in routine practice.

In the era of precision medicine, where decisions to improve patient outcomes are based on the biologic profile of an individual patient’s tumor, the BDP is creating novel solutions for the complex challenges of assay development.