Gastrointestinal study collects and tests patient specimens at multiple touchpoints

Case Study

Mayo Clinic Laboratories’ BioPharma Diagnostics team collaborates with biopharmaceutical, diagnostic, and other biotechnology companies to offer a wide range of laboratory testing and biopharma support for all phases of clinical trials.

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


An international diagnostics company is completing an observational study of patients with liver cirrhosis with the goal of validating a specific serum metabolite constellation to detect early hepatocellular carcinoma (HCC) lesions in liver cirrhosis. The study population includes patients with liver cirrhosis scheduled for surveillance for HCC using abdominal ultrasound and blood-based liver function tests, which may include testing for biomarkers. Enrolled patients will have specimens and data collected at multiple touchpoints, including a baseline and up to four follow-up visits.


BioPharma Diagnostics screened for patients with liver cirrhosis and approached eligible individuals for enrollment in the study. Serial blood draws from consented patients were collected in Mayo Clinic’s Clinical Research and Trials Unit and samples were stored in Biospecimens Accessioning and Processing, after which they were sent to the company for biomarker testing. BioPharma Diagnostics also completed data abstraction from the medical records.

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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.