Co-Diagnostics Eyes FDA Clearance for PCR Flu/RSV Test as It Expands Point-of-Care Platform — Co-Diagnostics, Inc. (Co-Dx)

Event summary

Co-Diagnostics' Chief Commercialization Officer Seth Egan participated in the Salt Lake Business Journal's 2026 Medical Devices and Innovation Roundtable on August 13.
The company submitted a 510(k) premarket notification to the FDA for its Co-Dx PCR Flu A/B & RSV upper respiratory multiplex test on August 18, 2026.
Co-Dx PCR platform (including PCR Home®, PCR Pro®, mobile app) is not yet FDA-cleared or available for sale.
The platform was conceived during the pandemic, with several years of investment and development leading to current commercial-readiness activities.

The big picture

Co-Diagnostics' participation in the Medical Devices and Innovation Roundtable underscores its strategic focus on expanding access to PCR diagnostics globally. The company's submission to the FDA for its Flu A/B & RSV test marks a critical step in its efforts to bring its point-of-care platform to market, potentially capitalizing on the growing demand for decentralized diagnostic solutions. The broader industry is grappling with AI integration and data interoperability, which could influence the platform's long-term competitiveness.

What we're watching

Regulatory Timing: Whether the FDA will accept and expedite review of Co-Diagnostics' 510(k) submission for the Flu A/B & RSV test.
Market Adoption: The pace at which Co-Diagnostics can commercialize its PCR platform in decentralized point-of-care settings post-clearance.
Competitive Positioning: How Co-Diagnostics' platform will differentiate itself in a market increasingly shaped by AI and data interoperability trends.