Infectious disease test gains U.S. FDA approval

Case Study

An ideal testing partner will offer extensive expertise in assay development and analytical validation services, along with access to biospecimens. Mayo Clinic Laboratories’ BioPharma Diagnostics team provides end-to-end support with strategic insight and assistance at every phase of the research and development journey.

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


A musculoskeletal diagnostics company is completing a prospective study to demonstrate its test’s performance in detecting periprosthetic joint infection (PJI) in synovial fluid. The company is looking to clinically validate its assay for detecting PJI by comparing its performance to the detection of PJI using the Musculoskeletal Infection Society (MSIS) criteria-based definition.


BioPharma Diagnostics screened for patients with suspected PJI and/or who were being considered for a knee or hip revision and approached eligible individuals for enrollment in the study. Synovial fluid from consented patients was collected preoperatively or intra-operatively from the affected prosthetic joint. The Clinical Microbiology Laboratory tested synovial fluid using the company’s assays and compared the results to the MSIS criteria for PJI. BioPharma Diagnostics also completed data abstraction from the medical record. The company included these results and data in its successful submission for approval to the U.S. Food and Drug Administration (FDA).

Download our e-book to learn more about how we support assay development and validation.

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.