As we reflect on 2024, CovarsaDx has much to celebrate. This year was marked by milestones that showcased our commitment to advancing diagnostic innovation, supporting groundbreaking technologies, and growing a team of top industry talent. Here’s a look back at some of our most impactful accomplishments.
Supporting FDA De Novo Approval for At-Home COVID-19 and Influenza Test
A major highlight of 2024 was our support in achieving FDA De Novo status for Healgen’s at-home COVID-19 and influenza test. This approval represents a game-changing advancement in over-the-counter diagnostics, enabling individuals to access reliable health insights from home. CovarsaDx’s regulatory and research teams provided critical expertise in clinical study design, regulatory submissions, and compliance, ensuring a seamless pathway to approval.
This project exemplifies how we partner with innovators to bring life-changing diagnostics to market. Learn more about this achievement here.
Strengthening Partnerships Through MDIC Membership
In 2024, we expanded our collaborative reach by joining the Medical Device Innovation Consortium (MDIC), a key network of industry leaders dedicated to driving innovation in medical devices and diagnostics. This membership enables CovarsaDx to contribute to critical initiatives that shape the future of diagnostics, including advancing regulatory strategies and improving patient outcomes.
Our involvement underscores our role as a trusted partner in clinical research, regulatory services, and quality assurance. Discover more about our MDIC initiatives here.
Showcasing Expertise at the Next Generation Dx Summit
The Next Generation Dx Summit was a defining moment for CovarsaDx this year. We were honored to join some of the brightest minds in diagnostics, healthcare, and biotech to explore the latest advancements in diagnostic technologies.
A standout moment was our President, Chermaen Lindberg, participating in a panel discussion on “Regulatory Strategies for Point-of-Care Diagnostics.” Topics included clinical study design for multiplex tests, navigating CLIA waiver pathways, and leveraging innovative labeling methods. Our presence reinforced CovarsaDx’s position as a leader in regulatory consulting and diagnostic innovation.
Expanding Our Team with Expertise in Diagnostics
CovarsaDx continued to grow in 2024, welcoming 20 talented professionals to our team. They bring a wealth of expertise in clinical operations, regulatory services, and quality assurance, enabling us to better serve our clients’ needs in IVD and medical device trials.
This growth reflects our commitment to building a team that drives progress in clinical research and supports the development of innovative diagnostic solutions.
Looking Ahead: Innovation and Impact in 2025
As we wrap up a successful year, we are energized by the opportunities ahead. From supporting clinical trials and regulatory approvals to driving advancements in patient-centered diagnostics, CovarsaDx remains committed to innovation, collaboration, and excellence.
Ready to partner with us on your next diagnostic breakthrough? Contact us today to learn more about our clinical research, regulatory consulting, and quality assurance services.
Here’s to even more growth, discovery, and impact in 2025!