FDA Clearance of Direct Renin Assay on IDS-ISYS
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.