Chinese FDA clearance for the IDS-iSYS instrument

21 August 2014

Immunodiagnostic Systems Holdings PLC

Chinese FDA clearance for the IDS-iSYS instrument

Immunodiagnostic Systems Holdings PLC ("IDS" or "the Company"), announces that it has received notice that the China Food and Drug Administration ("CFDA") has approved the Company's IDS-iSYS automated immunoassay instrument for sale in the Chinese market.

In May 2013 IDS appointed Beijing Leadman Biochemistry Technology Co, Ltd ("Leadman") as its exclusive distributor for the IDS-iSYS instrument and assays in the People's Republic of China. Since May 2013 IDS have been working closely with Leadman on CFDA clearance for the IDS-iSYS instrument as well as a number of Leadman and IDS automated immunoassays for use on the IDS-iSYS.

We anticipate CFDA approval of the first 30 Leadman assays for use on the IDS-iSYS instrument by the final quarter of this calendar year.

Patrik Dahlen CEO of IDS plc, commented, "We are delighted to receive the CFDA clearance of the IDS-iSYS instrument within our projected timeframe. This approval is a key milestone in allowing us to access the large and fast growing Chinese diagnostic market. The next step is to gain CFDA approval for the automated assays for use on the IDS-iSYS and we continue to work closely with our Chinese partner, Leadman, in order to achieve this".

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About Immunodiagnostic Systems Holdings PLC

The Group's vision is to be a leading solution provider to the clinical laboratory diagnostic market. IDS's strategy is focused on developing, internally and through partnership, its automated assay menu for its proprietary automated immunoassay analyser, the IDS-iSYS system. Internally the Group is focused on developing an endocrinology excellence menu and externally IDS works with partners to develop assay panels in complementary indication fields. The Group sells its products primarily in the clinical laboratory market across a range of customers from reference laboratories to physician office laboratories. IDS has field sales forces in certain European countries, including France and Germany, the United States and Brazil and works with distributors in other markets including China, Italy and Spain.