Launch of IDS-iSYS InaKtif MGP assay

Immunodiagnostic Systems Holdings plc.

1 March 2017

Launch of IDS-iSYS InaKtif MGP assay - new assay in the IDS CKD-MDB portfolio

Immunodiagnostic Systems Holdings plc (IDS), a specialist producer of manual and automated diagnostic testing kits and instruments for the clinical market, has launched the IDS-iSYS InaKtif MGP assay in the European market. This is a fully automated CLIA assay for use with plasma samples on the IDS-iSYS Automated System.

The launch of the IDS-iSYS InaKtif MGP assay is the first vascular calcification addition to the IDS Chronic Kidney Disease-Mineral Bone Disorder (CKD-MBD) portfolio. IDS believes this assay is the first fully automated solution for the measurement of InaKtif MGP.

The IDS-iSYS InaKtif MGP assay measures a patient's inactive dephosphorylated-uncarboxylated (dp-uc) isoform of Matrix Gla-Protein (MGP) and offers clinicians an easy way to assess the vitamin K status in the arterial vessel wall. A rise of the inactive form of MGP (dp-ucMGP) reflects a vitamin K deficiency in the vasculature. Insufficient vitamin K status may result in an increased risk of vascular calcification, which is the leading cause of death in patients with CKD-MBD.

Chronic kidney disease (CKD) is an increasing public health issue, with it estimated to be prevalent in 8 to 16% of the global population.

The global market size for MGP testing is estimated to be approximately US$10 million.

For further information:

Immunodiagnostic Systems Holdings plc Tel: +44 (0) 191 519 0660

Patricio Lacalle, Chief Executive Officer

Paul Martin, Group Finance Director

Peel Hunt LLP Tel: +44 (0) 20 7418 8900

James Steel

Oliver Jackson