- Gene therapy and adeno-associated viruses (AAVs)
- Cancer and immuno-oncology
- Neurodegenerative diseases
- Rare and complex genetic diseases
- Infectious diseases
- Genitourinary diseases
- Autoimmune disease
Using biomarkers to target patients who are more likely to respond to specific therapies has both accelerated and complicated drug development and approval. Quest Diagnostics can help simplify the companion diagnostics (CDx) process.
From initial research and definition through commercialization, you can trust that our industry-leading experts will be with you every step of the way. In collaboration with leading pharmaceutical, biotechnology, and in vitro diagnostic companies, we support companion diagnostic programs with a team that understands clinical development, biomarker assays, regulatory approaches, and commercialization considerations.
Our experienced regulatory team can support a broad range of submissions, including 510(k) and premarket approval (PMA). We also assist in:
Our team includes experts across every step of development, from biomarker assay development to clinical trial assay to companion diagnostic and market access.
When it comes to developing and deploying companion diagnostics, our experts lead the way in today’s novel therapeutics. Quest Diagnostics has partnered with pharma companies to provide precision medicine solutions across a wide range of disease areas. Our team works closely with you on considerations for the design of your biomarker program.
Learn how our companion diagnostic development expertise can advance your clinical development program.
Connect with our team of experts today.