Advancing IVD innovation

We’re committed to helping in vitro diagnostics (IVD) companies bridge the gap between product concept and regulatory approval. Our extensive testing menu, broad offering of predicate devices, scientific and medical expertise, medical technology and dedicated labs, clinical trials team members, and project management can facilitate a rapid development cycle across most IVD clinical trials.

Combined with our Biopharma Specialty Lab Services, we provide multi-site R&D and clinical testing services to support drug development and FDA clinical studies for IVD and BioPharma companies. This includes eligibility, safety, and biomarker testing, as well as method development and validation supporting R&D and FDA submissions of assays and clinical instrumentation. We perform testing services across many disciplines with specialties in oncology, immunology, microbiology, infectious disease, women’s health, and molecular genetics.  

We also offer boutique clinical trial services including custom reporting and data management services, customized project management, biorepository services, and expert consultation across all disciplines. We can offer thousands of tests through our laboratories and partnerships across the Quest network, and have a wide variety of platforms available.