Diabetes Marker Cleared by FDA
Diazyme Laboratories received FDA clearance to market its Direct Enzymatic Hemoglobin A1C assay kit. The company also received National Glycohemoglobin Standardization Program certification for the product.
Advantages of the new testing method include the ability to test a sample in one channel and no requirement to additionally assess hemoglobin. Perhaps most appealing for laboratory staff is direct reporting of results, expressed as A1C percentage. The system does not require calculations to extrapolate these findings.
With the large population of diabetics and the increasing importance of A1C measurement as a tool to monitor disease control, simplified means to assess may minimize workflow in the laboratory.
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April 30, 2007 Related topics: Product Launches