Built for Diagnostics: CovarsaDx’s IVD Expertise
We’re not learning diagnostics as we go. It’s who we are.
Our roots are firmly in diagnostics. CovarsaDx was founded by experts with decades of collective experience with in vitro diagnostics (IVD), giving our team a deep understanding of the unique challenges and opportunities sponsors face. From study design to regulatory clearance and market access, we focus solely on diagnostics. It’s what we know best and what we do every day. That singular focus has made us the partner of choice for innovators who want confidence their clinical studies are in the hands of a CRO that truly knows the diagnostics landscape.
Why IVD Companies Trust CovarsaDx
We don’t just support IVD studies, we were built for them. Our regulatory, clinical, and quality teams represent some of the best minds in diagnostics. We bring:
- Experience across 510(k), De Novo, PMA, and EUA pathways
- Strategic insight into analytical validity, clinical performance, and usability testing
- Partnerships with diagnostic-ready sites and investigators
- A deep understanding of FDA and international regulatory expectations for diagnostics
Full-Service IVD Support
We provide comprehensive clinical research services for IVD sponsors:
- Study Design & Protocol Development
- Investigator & Site Management
- Regulatory Submissions & Meeting Support
- Data Management, Collection & Sample Handling
- Performance & Usability Testing
- Labeling, Instructions for Use, and Post-Market Strategy
Diagnostic Depth Across Disease Areas
From infectious disease to oncology to women’s health, our IVD experience is broad and growing. Our expertise spans:
- Respiratory infections (COVID-19, influenza, RSV)
- Gastroenterology
- Oncology biomarkers and companion diagnostics
- STIs and women’s health panels
- Cardiac and metabolic risk detection
- Autoimmune and neurodegenerative disease diagnostics
Let’s Talk Diagnostics
If you’re developing a new diagnostic or scaling an existing test, let’s talk about how CovarsaDx can accelerate your path to market.