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CovarsaDx
Los Angeles, California, United States
- Ownership
- Private
- Employees
- ~20
- Development stage
- Other
01
Overview
CovarsaDx supports clinical trials enabling FDA clearances and approvals (De Novo, 510(k), EUA), most recently providing regulatory and research expertise for Healgen's at-home COVID-19 + influenza test, which achieved FDA De Novo approval in 2024. CovarsaDx is an active, independent Clinical Research Organization (CRO) specializing in in vitro diagnostics (IVDs) and medical devices, providing clinical research, regulatory consulting, and quality assurance services to help diagnostics innovators bring products to market efficiently.
- Therapeutic areas
- NephrologyEndocrinologyWomen's HealthGastroenterologyPulmonologyInfectious DiseasesOncology
- Modalities
- DeviceIn vitro diagnostic (IVD)
- Industry
- Contract Research Organization
02
Partnerships
Medical Device Innovation Consortium (MDIC)Healgen (clinical trial/regulatory support for at-home COVID-19/influenza test FDA approval)
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