Abnova Personal A1c Diabetes HbA1c Rapid Test Gains CFDA In Vitro Diagnostics Approval and Marketing in China

 Abnova Personal A1c Diabetes HbA1c Rapid Test Gains CFDA In Vitro Diagnostics Approval and Marketing in China

 

Abnova Corporation announced the launch of world’s first Personal A1c Diabetes HbA1c Rapid Test Kit. After three years of research and development, the Diabetes HbA1c Rapid Test Kit gains market approval for in vitro diagnostics (IVD), class II medical device, from Chinese food and drug administration (CFDA) in May 2016. As an entrance into the IVD market in China, Abnova is expecting to put this unique product into the Chinese market at the second half of 2016. As of now, Abnova has been in contact with several main pharmaceutical retailers and e-commerce platforms locating at Guangdong, Sichuan and other major provinces to deliberate sales and business cooperation.

 

Having the world’s largest diabetes epidemic, China has surpassed USA in terms of diabetes prevalence. By the year of 2015, Chinese diabetes population has reached to 110 million, which is accounted for approximately one-third of patients worldwide. For every 100 adults in China, 11.6 individuals have diabetes; however, over half of patients remain unaware or undiagnosed until complications are developed. Early diagnosis of diabetes is typically accomplished through the fasting glucose test (FGT). The glucose level measured by FGT method is often fluctuated and affected by short-term lifestyle changes, stress, or illness. The sensitivity and specificity of FGT is unable to reflect the long-term glycemic control in patients whereas the level of glycosylated hemoglobin (HbA1c) shows otherwise; therefore, HbA1c has been widely accepted as suitable index for monitoring diabetes in a long run. Abnova has transformed large professional instruments into portable HbA1c rapid detection kits. At the convenience of those who might be at high risk of diabetes, in the future, self-screening and preliminary testing of the disease can be performed at home before implementing detailed diagnosis at hospitals. Also, targeting areas with inadequate resources for health care, Abnova Personal A1c Diabetes HbA1c Rapid Test Kit can be easily accessible and effectively reduces healthcare costs.

 

In addition to the debut of Diabetes HbA1c Rapid Test, Abnova has made an enormous progress aiming for the precision medicine market in China. Abnova leverages the development of vertically integrated CytoQuest™ CR and CytoBot™ circulating rare cell enrichment and retrieval automations and its exclusive access to proprietary bioreagents and patented CytoChipNano technology to form alliances with various biotech companies and cancer specialized hospitals in major cities of mainland China, including Guangzhou, Hangzhou, Nanjing and etc. In collaboration to develop circulating tumor cells (CTCs) enrichment and isolation as a precision medicine platform for IVD, the detection of CTCs allows accurate diagnosis, treatment prognosis, metastasis predicament, and recurrence risk assessment; moreover, the non-invasive liquid biopsy overcomes the limitations caused by traditional imaging and tissue biopsies. While Chinese government continues to support and invest in precision medicine, with Abnova’s pioneer technology and expertise in CTC enrichment and isolation, it will continue to thrive and make breakthroughs in clinical applications.

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