AI Personalized Gene Therapy Design Platform GeneCraft Receives EMA Approval: Custom CRISPR Treatments for Rare Diseases

Swiss biotech company GeneDesign today announced that its AI-driven gene therapy design platform GeneCraft has received conditional approval from the European Medicines Agency (EMA). GeneCraft can automatically design personalized CRISPR gene editing treatment plans based on each rare disease patients specific genetic mutation characteristics.

Of approximately 7,000 known rare genetic diseases worldwide, 95% have no approved treatments. Traditionally, developing a dedicated drug for each rare disease costs hundreds of millions of dollars, making it commercially unviable. GeneCraft reduces personalized gene therapy design time from months to 72 hours and costs to one-hundredth of traditional approaches through AI automation.

GeneDesign CTO Dr. Markus Weber said GeneCraft has designed personalized treatment plans for 127 rare disease patients in clinical trials, with 89 showing significant symptom improvement within 6 months of treatment. Pricing will be announced next month, with the company partnering with national healthcare systems to ensure accessibility.