Published • loading... • Updated
QuidelOrtho 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.
Insights by Ground AI
14 Articles
14 Articles
Helena Independent Record+13 Reposted by 13 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
Read Full ArticleCoverage Details
Total News Sources14
Leaning Left1Leaning Right1Center10Last UpdatedBias Distribution84% Center
Bias Distribution
- 84% of the sources are Center
84% Center
C 84%
Factuality
To view factuality data please Upgrade to Premium
