Singleron Biotechnologies announced that its Matrix NEO automated single cell processing system has received Class II Medical Device Registration approval from the Jiangsu Medical Products Administration, China (Registration No.: 20252222135). Matrix NEO is the world's first automated single-cell analysis platform to achieve medical device clearance, marking a milestone in bringing single-cell sequencing from research laboratories into clinical practice.

Addressing Critical Clinical Translation Barriers

While single-cell sequencing is widely used in basic and translational research, clinical adoption has been limited by manual workflows, high costs, complex data interpretation, and regulatory uncertainty. Matrix NEO's approval validates the platform's consistent, reliable performance in single cell isolation, lysis, and mRNA capture—meeting the stringent quality standards required for clinical diagnostics.

Complete End-to-End Clinical Workflow

Matrix NEO integrates with Singleron's end-to-end single cell workflow, including:

Tissue preservation solutions for sample integrity

PythoN series automated tissue dissociation instruments

Code-free bioinformatics analysis tools and clinical databases

This end-to-end automation streamlines the path from sample collection to actionable clinical insights, reducing technical variability and accelerating time-to-result.

Advancing Precision Medicine

The approval reinforces Singleron's commitment to advancing precision medicine. The company supports global initiatives, including CERTAINTY, B2B-RARE, and AD-Omics. Singleron anticipates that Matrix NEO's regulatory clearance will accelerate the adoption of single-cell diagnostics in oncology, immunology, and beyond.