Search:   About Hypoguard Locations Events Careers News Room Media Kits Publications Press Releases Press Archive   home : about us : news room : press releases : press release Hypoguard obtains CLIA waived status for the D50 Urine Analyzer Mon 12/09/2002 SOURCE: Medisys Group PLC Medisys announces that its Hypoguard USA subsidiary has been granted a waived regulatory categorisation for the Diascreen 50 by the US Food and Drug Administration under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations. Grant of waived status expands the potential market for the Diascreen 50 significantly. The Diascreen 50 is Hypoguard's high throughput automated urinalysis machine which uses Hypoguard's proprietary Diascreen urinalysis test strips. Diascreen diagnostic tests are primarily used by physicians and care home workers to screen for endocrine and metabolic abnormalities and diseases of the kidneys. The CLIA regulations classify diagnostic tests based upon the complexity of performance and thereby determine which laboratories can perform particular tests. At launch the Diascreen 50's default classification was moderate complexity, meaning that the system could only be used by laboratories that were licensed as either high or moderate in terms of the complexity of the diagnostic tests they are licensed to perform. Although a sizable proportion of physician offices and long term care facilities do hold a high or moderate CLIR licence, the majority are only licensed to perform waived diagnostic tests. It is therefore anticipated that the grant of the waived status for the Diascreen 50 Urinalyser will open up a significantly wider market for Hypoguard's distribution partners. Diascreen urinalysis test strips are manufactured at Hypoguard's Minneapolis facility. The increased sales volumes anticipated as a result of the Diascreen 50 obtaining CLIR waiver status will allow further manufacturing scale economies to be achieved. The product line offers an opportunity to leverage Hypoguard's dry reagent manufacturing core competency at attractive gross margins. Hypoguard is a leading provider of innovative products and services to the worldwide point-of-care diagnostic marketplace, focused on the blood glucose monitoring and urine chemistry segments.       ©2004 Hypoguard. Privacy Policy | Terms and Conditions