QuidelOrtho (QDEL) announced a refocusing of its molecular diagnostics strategy. This strategy includes the intent to acquire full ownership of LEX Diagnostics after 510(k) clearance by the U.S. FDA for consideration at closing of approximately $100M and plans to discontinue the company’s Savanna platform development. In December 2023, QuidelOrtho invested in LEX Diagnostics, which included the exclusive option to acquire the company up to or shortly after 510(k) clearance by the FDA. LEX Diagnostics expects to submit dual 510(k) and CLIA-waiver applications to the FDA in the coming days and expects to receive 510(k) clearance in late 2025 or early 2026, depending on FDA review timelines. QuidelOrtho plans to discontinue its Savanna platform development. This decision reflects several factors, including the recent results of the Savanna RVP4X clinical trial. The company intends to work closely with its customers and partners to facilitate an orderly transition plan.
Confident Investing Starts Here:
- Easily unpack a company's performance with TipRanks' new KPI Data for smart investment decisions
- Receive undervalued, market resilient stocks right to your inbox with TipRanks' Smart Value Newsletter
Published first on TheFly – the ultimate source for real-time, market-moving breaking financial news. Try Now>>
Read More on QDEL:
- QuidelOrtho Stockholders Approve Equity Plan Changes
- QuidelOrtho Earnings Call: Growth Amid Challenges
- Trump announces trade deal, BoE lowers Bank Rate: Morning Buzz
- Jefferies upgrades QuidelOrtho to Buy, says ‘no news is good news’
- QuidelOrtho upgraded to Buy from Hold at Jefferies
Looking for a trading platform? Check out TipRanks' Best Online Brokers , and find the ideal broker for your trades.
Report an Issue