Hangzhou-based Oriomics, a cancer screening specialist backed by Hotgen Biotech Co., Ltd (SHA: 688068), has obtained Breakthrough Device Designation (BDD) from the US Food and Drug Administration (FDA) for its liver cancer multi-gene methylation + protein multi-omics screening reagent and supporting analysis software. This recognition highlights the innovative nature of Oriomics’ technology in early cancer detection.
Product Innovation
Developed using artificial intelligence, the product enables an innovative combination of multi-target biomarkers, multi-omics joint detection methods, and multi-biomarker collaborative evaluation. It includes automated interpretation of results based on machine learning algorithm software with accompanying reagent kits. This comprehensive approach allows for more accurate and efficient liver cancer screening compared to conventional methods.
Performance Advantages
The product demonstrates superior sensitivity and specificity compared to routine liver cancer screening methods, such as ultrasound examination combined with alpha-fetoprotein testing. It shows particularly excellent and stable performance in high-risk populations, including those with early liver cancer, small liver cancer, viral liver cancer, AFP-negative liver cancer, obesity, and non-alcoholic fatty liver disease.-Fineline Info & Tech
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