Business
US distribution agreement for diabetes assay kit
US distribution agreement for diabetes assay kit.
About this update from Ekf Diagnostics Holdings Plc
[{"type":"text","content":"\n \nRNS Number : 5580V EKF Diagnostics Holdings PLC 24 July 2018 \n\n \nThis announcement contains inside information for the purposes of Article 7 of Regulation (EU) No 596/2014 (MAR).\n \nEKF Diagnostics Holdings plc\n(\"EKF\", the \"Company\")\n \nEKF signs US distribution agreement for diabetes assay kit\n \nEKF Diagnostics Holdings plc (AIM: EKF), the AIM listed point-of-care business, announces that it has entered into an exclusive distribution agreement with Japanese pharmaceutical and diagnostic reagents firm, Asahi Kasei Pharma Corp. (\"Asahi Kasei\"), to market in the US Asahi Kasei's 510(k) cleared liquid reagent kits for the measurement of glycated albumin, Lucica® Glycated Albumin-L (\"Lucica GA\").\n \nGlycated albumin is a marker used to determine blood glucose control for patients with diabetes. Its measurement gives an average level of glycemia over the previous three weeks and is used at the start or change of patient therapy to determine more accurate medication regimens and doses, as well as allowing clinicians to assess overall therapy efficacy, compared to the snap-shot reading provided by simple blood glucose testing. Glycated albumin provides a more rapid indication of treatment efficacy or disease state deterioration, than glycated haemoglobin (HbA1c), which indicates glycemic levels over the preceding two or three months. This enables better control of diabetes, which could ultimately reduce overall costs associated with treating the effects of diabetes for health insurers.\n \nGlycated albumin measurement is furthermore regarded as useful in the case of pregnant women, patients with dialysis, patients with diseases that reduce the lifespan of erythrocytes (such as hemolytic anemia and renal anemia) and hemoglobin variants, for whom HbA1c may provide insufficient indication of glycemic level. The clinical utility of Lucica GA has been corroborated by various research reports.\n \nDeveloped by Asahi Kasei Pharma, Lucica GA is an in vitro diagnostic assay kit for glycated albumin for use with biochemical auto-analyzers. Lucica GA has been approved and launched in Japan (2002), China (2005), Korea (2013), Indonesia (2013), Taiwan (2015) and Europe (2015), and Asahi Kasei Pharma has received 510(k) clearance for Lucica GA from the US Food and Drug Adm...