CovarsaDx Strengthens Regulatory Expertise with Industry Veteran David Ikeda
Los Angeles, Calif., February 10, 2025 – CovarsaDx, a prominent Clinical Research Organization (CRO) well-known for its expertise in the areas […]
Press Releases
CovarsaDx® Research Team Provides Key Support for the FDA 510(k) Clearance for OSANG Healthcare’s Over-The-Counter QuickFinder™ COVID-19/Flu Antigen Self-Test and QuickFinder™ COVID-19/Flu Antigen Pro Test
CovarsaDx®, a prominent Clinical Research Organization (CRO) renowned for its expertise in the areas of in-vitro diagnostics (IVDs) and medical
Nuclein’s DASH® SARS-CoV-2 & Flu A/B Test for Use on the DASH® Rapid PCR System Receives FDA 510(k) Clearance and CLIA Waiver with Key Support from CovarsaDx® Research Team
CovarsaDx®, a prominent Clinical Research Organization (CRO) renowned for its in vitro diagnostics (IVDs) and medical device expertise, announced today that one of its clinical research study clients, Nuclein, LLC, has received U.S. Food and Drug Administration (FDA) 510(k) clearance and a Clinical Laboratory Improvement Amendments (CLIA) waiver for the DASH® SARS-CoV-2 & Flu A/B Test for use on the DASH® Rapid PCR System.
CovarsaDx Welcomes Rich Masino as Senior Director of Strategic Partnerships and Business Development
CovarsaDx, a clinical research organization at the forefront of in vitro diagnostics (IVD) and medical device trials, has appointed Rich Masino as senior director of strategic partnerships and business development. Bringing over 30 years of experience in biotech, pharma, and medical device diagnostics, Masino will focus on driving growth and forging strategic partnerships across CovarsaDx and ZoaDx, while reporting directly to the company’s chief executive officer (CEO).
Healgen’s At-Home COVID-19 and Influenza Test Achieves FDA De NovoStatus with Key Support from CovarsaDx® Research Team
CovarsaDx®, a prominent Clinical Research Organization (CRO) renowned for its expertise in the areas of in vitro diagnostics (IVDs) and medical devices, proudly announced today that a clinical research study, conducted on behalf of Healgen Scientific, LLC, through the Independent Test Assessment Program (ITAP), part of National Institutes of Health (NIH) Rapid Acceleration of Diagnostics (RADx®) Tech, has received De Novo marketing authorization from the U.S. Food and Drug Administration (FDA) for the Healgen Rapid Check® COVID-19/Flu A&B Antigen Test.
CovarsaDx Expands Collaborative Efforts Through MDIC Membership and Key Initiatives
CovarsaDx is proud to announce its membership in the Medical Device Innovation Consortium (MDIC). This partnership marks a significant milestone in CovarsaDx’s ongoing mission to advance innovation in healthcare technology by providing reliable clinical validation results from an elite network of experienced investigators.