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
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.