Abnova’s Personal A1c Diabetes Rapid Test Completed Clinical Trial and TFDA Submission
Neihu, Taiwan (March 9, 2015)
Abnova announced today that its Personal A1c diabetes rapid test has completed clinical trial at Chung Shan Hospital, Taichung, Taiwan. The 220 patients clinical trial analyzed the reproducibility and accuracy of the Personal A1c lateral flow immunoassay for rapid, semi-quantitative analysis of HbA1c at several cutoff levels. The intended use of Personal A1c test is screening and monitoring of diabetes in high risk and general populations. According to the WHO criteria, a HbA1c level of 6.5% or more is a definitive diagnosis of diabetes. Personal A1c is the only rapid, semi-quantitative lateral flow immunoassay test being developed for the Point-of-Care (POC) and Over-the Counter (OTC) diabetic market.
Personal A1c rapid test has a simple and convenient design which mirrors the pregnancy test. The Personal A1c test does not need an instrument and can be administered by the clinical personnel in the POC market or by the patient in the OTC market. One of the underpinning studies in the clinical trial is to assess the ease of use and accuracy of the test administered by the patient alone. The concept of inexpensive HbA1c rapid test is not new, but its development has been hampered by technical hurdles in HbA1c monoclonal antibody, gold nanoparticle, and their effective integration to achieve a clinically significant HbA1c cutoff level in the lateral flow environment for diabetic screening and monitoring.
Total number of people with diabetes worldwide is projected to rise from 382 million in 2013 to 592 million in 2035*. China, India, and Bangladesh have the highest number of diabetic patients. In China, there are about 113 million adults with diabetes and 493 million adults with prediabetes**. The prevalence of diabetes and prediabetes is reaching epidemic proportions in China. Personal A1c is positioned to target this fast growing market in China. Abnova’s Personal A1c test aims to complete China clinical trial by first quarter 2015.
*International Diabetes Federation. IDF Diabetes Atlas, 6th edn. Brussels, Belgium: International Diabetes Federation, 2013.
**Prevalence and Control of Diabetes in Chinese Adults. Xu, et al. JAMA 2013 Sep 4;310(9):948-59.
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About Abnova
Abnova has established a comprehensive portfolio of fully integrated solutions and services to address the needs of the clinical research and in vitro diagnostic industry. Abnova’s ISO13485 and GMP certified facility provide its customers and ISO15189 medical service laboratory partner access to monoclonal antibody, ELISA kit, FISH probe, and circulating cell isolation and retrieval system. ( www.abnova.com)
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