Expertise
Built for Diagnostics: CovarsaDx’s IVD Expertise
Born in the Pandemic. Built for the Future of Diagnostics
CovarsaDx was founded in 2020, during one of the most pivotal moments in modern healthcare. As the world raced to understand, diagnose, and manage COVID-19, we emerged as a trusted partner to diagnostic innovators determined to make an impact. Our roots are in IVD, and it shows. From day one, we’ve specialized in helping in vitro diagnostic companies navigate the complex, high-stakes path from breakthrough idea to regulatory clearance and market access.
What started with pandemic response efforts has since evolved into something far bigger: a prominent CRO singularly focused on diagnostics and medical devices.
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 support the entire IVD lifecycle:
- Study Design & Protocol Development
- Investigator & Site Management
- Regulatory Submissions & Meeting Support
- Data Collection & Sample Handling
- Performance & Usability Testing
- Labeling, Instructions for Use, and Post-Market Strategy
Diagnostic Depth Across Therapeutic 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
- And more
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.
let’s talk about how CovarsaDx can accelerate your path to market.