Ekf Diagnostics Regulatory News (EKF)

This announcement contains inside information for the purposes of Article 7 of Regulation (EU) No 596/2014 (MAR).

EKF Diagnostics Holdings plc

("EKF", the "Company")

EKF signs US distribution agreement for diabetes assay kit

EKF 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").

Glycated 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.

Glycated 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.

Developed 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 Administration (FDA) on October 12, 2017. Under the distribution agreement EKF will undertake marketing, promotion and distribution of the product which will be manufactured by Asahi Kasei. Lucica GA will be sold through EKF's established reagent sales network in the US and sold alongside EKF's clinical chemistry products such as Beta-Hydroxybutyrate (BhB) which is currently used in over 1,100 hospitals in the US.

The number of people with diabetes continues to increase, and diabetes is known to raise the risks of heart disease, cancer, and dementia. According to the US Centers for Disease Control and Prevention (CDC), there are 30.3 million people in the US (9% of the population) with diabetes and 84.1 million (34% of the adult population aged 18 years or older) who are considered to have prediabetes. There is wide recognition of the urgent necessity of effective preventive measures.

Commenting, Julian Baines, CEO of EKF, said:

"This US distribution deal is an exciting and original addition to our diabetes portfolio and will work really well alongside BhB. In addition the agreement will create an additional revenue line in our Clinical Chemistry portfolio and will utilise our already established US reagent sales channel. We look forward to working with Asahi Kasei to promote a new option of glycemic control to diabetes patients and to healthcare professionals."

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