China-based Jiangsu Cowin Biotech Co., Ltd. (SHA: 688426) announced receiving a Category III medical device license from the National Medical Products Administration (NMPA) for its human Septin9, SDC2, and NDRG4 gene methylation detection kit (fluorescence PCR method). This approval marks a significant step forward in the company’s efforts to provide innovative diagnostic solutions for colorectal cancer (CRC) risk assessment.
Product Details and Application
The detection kit qualitatively assesses the methylation status of three genes—Septin9, SDC2, and NDRG4—in human fecal samples. By analyzing these biomarkers, the kit aids in the diagnosis of colorectal cancer risk in patients. This non-invasive approach offers a convenient alternative to traditional screening methods, potentially improving patient compliance and early detection rates.
Market and Clinical Implications
The introduction of this gene methylation detection kit aligns with global trends toward personalized and precision medicine. By identifying individuals at higher risk of colorectal cancer, the kit enables timely intervention and management, which can significantly improve patient outcomes. The NMPA’s approval underscores the product’s potential to make a meaningful impact in clinical practice and public health initiatives.-Fineline Info & Tech
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