LifeScale Yeast Kit (LSYST) with the LifeScale AST system has received Breakthrough Device Designation

FDA Grants Breakthrough Device Designation to LifeScale Yeast Kit

Advancing Rapid AST for Life-Threatening Yeast Infections

We’re thrilled to announce that the LifeScale Yeast Kit (LSYST) with the LifeScale AST system has received Breakthrough Device Designation from the U.S. FDA! This designation is awarded to technologies that may provide more effective treatment or diagnosis of life-threatening conditions, such as Candida auris, especially where no approved alternatives currently exist. What does this mean for you?

• ✅ Rapid AST directly from positive blood cultures
• ✅ Coverage of key Candida species with clinically relevant antifungals
• ✅ Supports earlier, targeted treatment decisions
• ✅ Recognized by the FDA as a potentially transformative innovation

This is a major milestone—and we’re just getting started. We’d like to thank all those who have supported the development of this technology and invite you to join us as we move forward in redefining what’s possible in infectious disease diagnostics.