Oncology surveillance biomarker study enrolls patients and evaluates assay

Case Study

While access to the right testing is critical, so is the ability to organize a team of laboratory, medical, and business professionals to collaborate, develop, and launch tests specific to every partner’s therapeutic strategy. Mayo Clinic Laboratories’ BioPharma Diagnostics team supports companies from discovery to post-market in advancing their precision medicine initiatives.

The following example demonstrates how BioPharma Diagnostics collaborated with a biotech company to meet their clinical and research testing needs. Identifying information has been removed.


A biotechnology company is completing a surveillance biomarker study to establish a cutoff for its assay developed to monitor the progression or regression of disease in patients with well-defined gastroenteropancreatic neuroendocrine tumors (GEP-NETs). The study looks at the biomarker chromogranin A (CGA). The assay is to be used as an aid in monitoring disease progression during the course of disease and treatment in patients with GEP-NETs, in conjunction with other clinical monitoring methods.


BioPharma Diagnostics screened for patients with GEP-NETs for enrollment in the study. Serial blood draws were performed on consented patients and serum was tested on the company’s assay in the Clinical Immunoassay Laboratory. BioPharma Diagnostics also completed data abstraction from the medical record.

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Luci Gens

Luci Gens is a marketing manager at Mayo Clinic Laboratories. She joined Mayo Clinic in 2022 and has over ten years of experience in hospital-based marketing and communications.