| Web: | mayocliniclabs.com |
|---|---|
| Email: | mcl@mayo.edu |
| Telephone: | 800-533-1710 |
| International: | +1 855-379-3115 |
| Values are valid only on day of printing | |
| Web: | mayocliniclabs.com |
|---|---|
| Email: | mcl@mayo.edu |
| Telephone: | 800-533-1710 |
| International: | +1 855-379-3115 |
| Values are valid only on day of printing | |
When developing new assays and devices, the step of analytical validation is crucial to the success of a project. Medical device, biopharma, and diagnostic companies are looking for testing partners who fulfill a wide range of requirements, which may vary widely from project to project. A good partner will have the flexibility and range to meet the needs of each new project while bringing specific expertise in the latest scientific and regulatory requirements.
The following stories are examples of how companies can work with Mayo Clinic Laboratories’ BioPharma Diagnostics team on their clinical and research testing needs. They illustrate different capabilities and collaborations and do not contain identifying information.
Aiming to advance understanding of hard-to-predict gastroenteropancreatic neuroendocrine tumors (GEP-NETs), Thermo Fisher Scientific joined forces with Mayo Clinic and BioPharma Diagnostics to validate and gain U.S. regulatory clearance of a novel, automated assay aimed at detecting a biomarker associated with the progressive disease.
Mayo Clinic Laboratories’ BioPharma Diagnostics team facilitates specimen collections and access to archived samples to support clinical trials and diagnostic validation projects that advance healthcare. In this collaboration example, learn how BioPharma Diagnostics helped a research healthcare company evaluate the clinical performance of three assays designed to aid in the diagnosis of Alzheimer’s disease and other causes of cognitive impairment.
Mayo Clinic Laboratories’ BioPharma Diagnostics team supports companies from discovery to post-market in advancing their precision medicine initiatives. In this collaboration example, learn how BioPharma Diagnostics helped a biotech company complete 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).
An ideal testing partner will offer extensive expertise in assay development and analytical validation services, along with access to biospecimens. In this collaboration example, learn how Mayo Clinic Laboratories’ BioPharma Diagnostics team helped a musculoskeletal diagnostics company complete a prospective study to demonstrate its test’s performance in detecting periprosthetic joint infection (PJI) in synovial fluid.
Mayo Clinic Laboratories’ BioPharma Diagnostics team collaborates with biopharmaceutical, diagnostic, and other research companies to offer a wide range of laboratory testing and biopharma support for all phases of clinical trials. In this collaboration example, learn how BioPharma Diagnostics helped an international diagnostics company complete a 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.