US EditionQuidelOrtho Announces Strategy to Accelerate Growth in Molecular Diagnostics
- QuidelOrtho plans to complete the acquisition of LEX Diagnostics following FDA 510 clearance and intends to halt further development of its Savanna platform.
- This strategy follows the December 2023 investment in LEX Diagnostics, reflecting the company's evaluation of clinical data, investment needs, and market opportunities for both platforms.
- LEX Diagnostics plans to file both 510 and CLIA-waiver applications with the FDA imminently, aiming for regulatory clearance by late 2025 or early 2026, subject to the FDA’s review schedule.
- Brian J. Blaser, CEO of QuidelOrtho, remarked that the acquisition will enhance and expedite the company's growth within the point-of-care molecular diagnostics sector, which remains one of the fastest-expanding areas of the diagnostics market.
- The acquisition and discontinuation plans carry risks such as regulatory delays, integration challenges, and market fluctuations that could affect future financial results and operational goals.
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Helena Independent Record+14 Reposted by 14 other sources
QuidelOrtho Announces Strategy to Accelerate Growth in Molecular Diagnostics
―Company Intends to Acquire LEX Diagnostics Upon U.S. FDA Clearance―
·Helena, United States
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