Zepto Life Technology
Zepto Life Technology is dedicated to improving diagnostic standards and advancing patient outcomes worldwide through innovative molecular diagnostics and regulatory support. They focus on highly sensitive, multiplexed, and automated diagnostic platforms, supporting FDA regulatory submissions and clinical testing services.
Industries
Nr. of Employees
small (1-50)
Zepto Life Technology
Saint Paul, Minnesota, United States, North America
Products
Multiplex fungal detection panel for invasive fungal infections
A multiplex molecular panel designed to detect a broad set of invasive fungal pathogens with reported high sensitivity; intended for rapid detection to support clinical decision-making (platform not marketed in the U.S. per site disclaimer).
Multiplex fungal detection panel for invasive fungal infections
A multiplex molecular panel designed to detect a broad set of invasive fungal pathogens with reported high sensitivity; intended for rapid detection to support clinical decision-making (platform not marketed in the U.S. per site disclaimer).
Services
CLIA-certified diagnostic testing (central reference laboratory)
High-complexity CLIA laboratory testing services for clinical samples, including a broad test menu focused on sexually transmitted infections (STIs) and respiratory pathogens; services include trained staff, customized client reports, and rapid turnaround.
CRO services for IVD and medical device analytical testing and regulatory support
Contract research organization services covering analytical study design and execution, product validation, regulatory strategy and submission support (including FDA EUA and 510(k)), clinical trial support (study management, biostatistics, data management), QMS development, and LDT capabilities within onsite CLIA and BSL 2+ facilities.
Platform development for rapid, multiplex molecular detection
R&D and assay development services focused on magnetic sensing lab-on-chip platforms designed for high-sensitivity, high-plex molecular detection with rapid turnaround suitable for point-of-care or near-patient applications.
CLIA-certified diagnostic testing (central reference laboratory)
High-complexity CLIA laboratory testing services for clinical samples, including a broad test menu focused on sexually transmitted infections (STIs) and respiratory pathogens; services include trained staff, customized client reports, and rapid turnaround.
CRO services for IVD and medical device analytical testing and regulatory support
Contract research organization services covering analytical study design and execution, product validation, regulatory strategy and submission support (including FDA EUA and 510(k)), clinical trial support (study management, biostatistics, data management), QMS development, and LDT capabilities within onsite CLIA and BSL 2+ facilities.
Platform development for rapid, multiplex molecular detection
R&D and assay development services focused on magnetic sensing lab-on-chip platforms designed for high-sensitivity, high-plex molecular detection with rapid turnaround suitable for point-of-care or near-patient applications.
Expertise Areas
- Molecular diagnostics development
- Point-of-care and rapid diagnostic assay development
- Central reference laboratory testing (CLIA high-complexity)
- Analytical validation and performance testing
Key Technologies
- Giant magnetoresistance (magnetic sensing) for molecular detection
- Lab-on-a-chip platforms
- Magnetic nanoparticle-based assay reagents
- Multiplexed sensor arrays (high-plex detection)