In vitro diagnostic solutions
COMPREHENSIVE IN VITRO DIAGNOSTIC SUPPORT
BioPharma Diagnostics provides top-tier collaborative services to support biopharmaceutical, diagnostic, and medical device companies. We offer the flexibility and the right range of capabilities to meet the needs of each new project while bringing specific expertise in the latest scientific advances and regulatory requirements.
We deliver analytical and clinical validation services for new assays and devices through College of American Pathology (CAP)-accredited and Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory environments. Backed by more than 160 physicians and scientists supporting laboratory medicine and pathology, our experienced, highly trained team has conducted more than 200 validation projects that align with the latest scientific and regulatory requirements.
HOW WE CAN HELP
Insider access
An in vitro diagnostics (IVD) validation through BioPharma Diagnostics enables access to Mayo Clinic Laboratories’ extensive capabilities, including:
- Access to biospecimens across the wide range of conditions treated at Mayo Clinic.
- Proven analytical and clinical validation services.
- A dedicated CAP ISO 15189 and CLIA-certified biopharma laboratory.
- Strategic collaborations with Mayo Clinic medical and scientific experts.
- Nationwide, multisite testing and sample collection.
- Our experienced Professional Services team.
End-to-end support
Powered by Mayo Clinic Laboratories’ expansive testing menu, BioPharma Diagnostics not only advances precision medicine, but serves as a strategic partner at every phase of the research and development journey.
By leveraging the clinical and research assay development capabilities of Mayo Clinic, we organize a team of laboratory, medical, and business professionals to collaborate, develop, and launch tests specific to every partner’s therapeutic strategy.
With three Mayo Clinic campuses and a health system spanning three states, BioPharma Diagnostics can facilitate multistate testing and/or prospective sample collection to support clinical trials and diagnostic validation projects.
Laboratory space
From startups to biopharma and in vitro diagnostics companies, our dedicated BioPharma Diagnostics lab space provides resources needed for assay development, instrument or assay kit validation projects, and co-development opportunities. This CAP/CLIA space is International Organization for Standardization (ISO) 15189-certified and was designed to allow for quick reconfiguration to meet each project’s needs. The lab is staffed by highly trained assay development scientists and good clinical practice (GCP) laboratory personnel.
Connect with us to learn more about our COMPREHENSIVE IN VITRO DIAGNOSTIC SUPPORT.
Schedule an appointment with one of our team members.