FDA Grants Breakthrough Device Designation to Zepto Life Technology’s FungiFlex Mold Panel
Zepto Life Technology has received FDA Breakthrough Device Designation for its FungiFlex Mold Panel, a liquid biopsy test that detects fungal cell-free DNA in plasma. The assay identifies 14 clinically important mold pathogens and aims to improve early diagnosis, pathogen identification, and treatment decisions for invasive mold infections.
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