Polymer Technology Systems, Inc. Announces Over-The-Counter Clearance for Blood Ketone Test
INDIANAPOLIS, Jan. 3 /PRNewswire/ -- Polymer Technology Systems, Inc., a privately held medical diagnostics manufacturer, announced they have received clearance from the Food and Drug Administration to market their blood ketone test to the consumer market. The test runs on the company's BioScanner 2000(TM) analyzer and is designed for both home and physician office use. This brings the number of tests available for the BioScanner 2000(TM) in the over-the-counter market to three including glucose and total cholesterol. "Clearance of our blood ketone test is a significant step forward for PTS and the development of the BioScanner 2000," said Tracy Thompson, vice- president, business development. "Clearance of this tests means the BioScanner is the only system available to consumers and physicians capable of running glucose, cholesterol and ketones on the same instrument and takes advantage of the advanced optical properties of the system. This provides diabetics and heart patients the opportunity to utilize the same technology as their physicians in managing their disease." Ketones are produced in the body when insufficient insulin is available to metabolize glucose. As a result the body metabolizes fats and creates a state known as diabetic ketoacidosis (DKA), a condition that can be fatal. Previously ketones were measured in the urine using simple dipsticks, but this is a non-specific test and can lead to false negatives. The BioScanner test measures beta-hydroxybutyrate (BHBA) which is the predominant ketone type found in blood. The American Diabetes Association has published a position paper on ketones and recommends the testing of blood ketones over urine ketones. Polymer Technology Systems, Inc. develops and manufacturers products for the management of diabetes and its complications. Typical complications from diabetes include heart disease, peripheral vascular disease, blindness and kidney damage. Diabetes affects 16 million Americans and is managed through diet, medication and monitoring of blood parameters such as glucose, microalbumin, etc. In addition to the current portfolio of tests Polymer Technology Systems have direct LDL, microalbumin and hemoglobin A1c in development. Direct HDL-cholesterol and triglyceride tests are currently with the FDA awaiting consumer clearance.
SOURCE Polymer Technology Systems, Inc.
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