Co‑Diagnostics, Inc. (NASDAQ: CODX) began clinical performance testing of its new Co‑Dx™ PCR Flu A/B, COVID‑19, RSV Test Kit, a four‑plex assay that simultaneously detects influenza A, influenza B, COVID‑19 and respiratory syncytial virus on the Co‑Dx PCR Pro instrument. The test kit is designed for point‑of‑care use in physician offices, workplaces and other near‑patient settings.
Co‑Diagnostics’ move into clinical evaluation marks a key regulatory milestone. The data generated will support a 510(k) submission to the U.S. Food and Drug Administration for both the multiplex test and the Co‑Dx PCR Pro platform, which remains under regulatory review and is not yet available for sale. Successful clearance would enable the company to commercialize its portable PCR platform in the U.S. market and beyond.
The global market for respiratory infectious disease diagnostics was valued at $54.58 billion in 2024 and is projected to reach $73.56 billion by 2030. Demand for high‑accuracy, near‑patient PCR testing is rising as clinicians seek rapid, reliable results outside of centralized laboratories. Co‑Diagnostics’ proprietary Co‑Primers technology is positioned to enhance test specificity and reduce primer‑dimer formation, giving the company a competitive edge in this expanding market.
Financially, the company reported a sharp decline in revenue for the third quarter of 2025, with $0.1 million in sales compared to $0.6 million in the same period a year earlier. Net loss narrowed to $5.9 million from $9.7 million, reflecting disciplined cost management amid lower top line. Cash and cash equivalents fell to $11.4 million from $37.7 million at the end of Q3 2024, raising concerns about future capital needs. These headwinds underscore the importance of the regulatory milestone and the company’s focus on cost control.
CEO Dwight Egan emphasized that regulatory clearance and commercialization of the Co‑Dx PCR platform remain the company’s primary objectives. He noted that market research indicates strong demand for decentralized, gold‑standard PCR testing. Co‑Diagnostics is also pursuing international expansion through joint ventures in India and Saudi Arabia, and has announced plans to integrate artificial intelligence into its Co‑Dx™ Primer Ai™ Platform to further differentiate its product line.
Investors have focused on the revenue miss and the company’s cash position, but the initiation of clinical testing is viewed as a positive step toward regulatory approval and future revenue growth. The milestone signals progress in the company’s long‑term strategy to expand its test portfolio and bring its portable PCR technology to a broader market.
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