Nano CAST™ 암 솔루션

• Background Problem: Tissue biopsies are invasive and difficult to monitor repeatedly. Liquid biopsies are an alternative, but CTCs are rare, making capture and analysis difficult. Standardization, speed, and cost are important in clinical settings.

• Limitations of Existing Methods: (1) Manual preprocessing, staining, and reading lead to variability and high labor costs. (2) Some tests (mainly cfDNA) have limited "cell-level information." (3) Long TAT (turnaround time) delays decision-making.

• Combines a semiconductor-based biochip (nano structure/surface chemistry) + automated immunofluorescence staining + AI image reading into an "end-to-end automated workflow" for consistency and scalability. • CES introduction criteria: 16mL blood, 90%+ capture efficiency/sensitivity, 60% reduction in labor costs, aiming for results within hours.

• Adopters: Cancer centers/tertiary hospitals, clinical laboratories, diagnostic service labs, clinical trial institutions/research institutions. • B2C/B2B/B2G: Primarily B2B (medical) + some public research (B2G).

• Environmental/Regulatory Constraints: National IVD approvals, accumulation of clinical evidence, insurance reimbursement, and data governance will determine the speed of expansion. • Industrial/Market Scalability: Potential for expansion into rare cell/single-cell analysis research beyond cancer, but "reproducibility and clinical validity" are prerequisites for the clinical market.

• CES Award Context: Strong message of medical workflow automation + semiconductor/AI convergence. • Technical Completeness: Automation is attractive, but clinical performance, quality management (QMS), and multi-center validation are key. • Market Expectations: High demand, but adoption will take time due to regulations/operations/reimbursement. • Overestimation/Underestimation Factors: Winning a CES award does not prove clinical value; subsequent clinical data release is critical.