GeneDx, a biotech company that uses artificial intelligence for genomics-related diagnostic testing, has seen its stock surge again after the FDA issued guidance on the use of AI in medical devices.
The FDA’s draft guidelines provide recommendations for AI-enabled devices across design, development, maintenance, and documentation. This news is promising for GeneDx, which has been using AI to improve its genetic testing services.
GeneDx provides whole genome and exome sequencing to help identify rare diseases, primarily in children. The company’s stock has increased by almost 30-fold in 2024, with shares rising 13.2% on Monday to close at $89.61. This represents a significant jump for the company, which was listed as the 40th best growth stock on the IBD 50 list.
The FDA’s guidance is seen as a positive development for GeneDx, which could lead to increased adoption of its AI-powered diagnostic testing services. By providing answers early, genetic testing can help avoid what CEO Katherine Stueland calls a “diagnostic odyssey.” The company only tests for diseases with potential solutions, such as clinical studies or dietary changes.
As one of the top growth stocks on the IBD 50 list, GeneDx is expected to continue its upward momentum. With the FDA’s guidance in place, investors may see even more gains from this biotech company that’s revolutionizing genetic testing.
Source: https://www.investors.com/news/technology/genedx-stock-fda-ai-draft-guidance