FDA clearance of automated Direct Renin assay on the IDS-iSYS system
Immunodiagnostic Systems Holdings plc ("IDS" or '"the Company") announces that it has received USA FDA (Food and Drug Administration) clearance for its Direct Renin assay for use on its IDS-iSYS system, enabling IDS to enter the US market with this product.
The IDS-iSYS Direct Renin immunoassay is used to determine the amount of active renin present in the blood. Results of the test are used in conjunction with other clinical and laboratory data to assist clinicians in the investigation of hypertension related disorders such as primary aldosteronism and renovascular hypertension. The test enables the quantitative determination of renin in less than an hour, providing laboratories with a fast and reliable alternative to existing laborious manual methods, a necessity when screening in extended hypertensive populations.
According to the WHO, hypertension affects 20% of the population. Worldwide, hypertension is the third leading cause of death after malnutrition and diseases related to smoking. According to the Centers for Disease Control and Prevention 67 million American adults (31%) have high blood pressure, one in every three American adults.
IDS launched the automated Direct Renin immunoassay in Europe in June 2012 and the FDA clearance now allows the Company to market the assay in the United States.
Patrik Dahlen CEO of IDS plc, commented, "We are delighted to receive the clearance of our automated Direct Renin immunoassay allowing us to enter the US market with this important diagnostic test. We remain focused on increasing the assay menu available to customers on the IDS-iSYS automated system."