Quotient Diagnostics receives SFDA approval

 27th Jan 2011

EKF Diagnostics Holdings plc (AIM: EKF) , the AIM listed point-of-care diagnostics business, announces that its wholly owned subsidiary, Quotient Diagnostics Limited (“Quotient”), has received approval from China’s Safety for Food and Drugs Administration (“SFDA”) for its Quo-Test A1C test. With this approval, Quotient will be able to start the promotion, distribution and sale of the Quo-Test A1c Reagent kit on its proprietary Quo-Test platform in China.

It is expected that Quotient, through its agreement with Shanghai Upper Biotech (“SUB”), will receive the license within the next 2 weeks allowing the distribution of Quotient’s products in China. 

Diabetes patients need to regularly test for their level of A1c, also known as glycated haemoglobin, as it provides health professionals with an indication of the effectiveness of the treatment provided. 

According to a recent epidemiologic study by the International Diabetes Federation, China has become the centre of the diabetes epidemic, which at 92.4 million makes it the country with the largest diabetic population in the world; this figure is expected to reach half a billion by 2030. It is thought that 60 per cent of diabetics remain undiagnosed due to poor public awareness. China’s health authorities are committed to health reforms in order to increase the offer of primary care.

Julian Baines, CEO of EKF Diagnostics Holdings plc, said:

“Regular HbA1c monitoring can help to minimise the long term complications of diabetes and Quotient is committed to making testing more widely available and more affordable. It has been shown that immediate feedback of A1c results significantly improves patients’ glycaemic control at 6 and 12 months. We are pleased the SFDA has approved the Quo-Test so that we will now be able to offer our A1c product to one of the largest diabetic populations in the world. Our collaboration with Shanghai Upper Biotech will ensure a complete and comprehensive coverage of the territory. SUB has an excellent track record of providing top level service and customer support.”