NEW YORK, Nov. 6 /PRNewswire/ -- Tomen America Inc. and Nippon Kayaku Co. Ltd. today announced that the U.S. Food and Drug Administration (FDA) has granted marketing clearance for the GlycoMark(TM) test. This blood test is cleared for the intermediate term monitoring of glycemic control (measurement of overall glucose control over time) in people with diabetes. Data from a prospective clinical study conducted at Washington University (St. Louis, Missouri) is being presented today at the Diabetes Technology Meeting in San Francisco, California.
The GlycoMark(TM) test measures the level of 1,5-anhydroglucitol (1,5-AG) in human blood. 1,5-AG responds rapidly to increasing glucose levels and reflects average glucose levels over a period of a few days to 2 weeks. This may allow patients to seek medical intervention in a timely manner such as when starting or changing therapy, empowering patients to achieve and maintain control of their disease.
According to the American Diabetes Association, monitoring of glycemic status is a cornerstone of diabetes care. Glycemic tests such as hemoglobin A1c, fructosamine, and now GlycoMark(TM), provide measures of overall glucose control and are important in maintaining near-normal glucose levels. As an intermediate-term monitoring test of glycemic control, GlycoMark(TM) is an additional tool for the physician to measure more recent glycemic status to monitor diabetes therapy timely and effectively.
"GlycoMark(TM) is an important new test which physicians may use to monitor glycemic control," said Dr. Steve Edelman, Professor of Medicine at the University of California, San Diego. "Fructosamine has been somewhat disappointing as a measure of short-term glycemic control due to its inherent variability, and the availability of GlycoMark(TM) would certainly be a welcome addition to the tools available to monitor glycemia."
"Receiving FDA marketing clearance for the GlycoMark(TM) test in the United States is an important milestone for Tomen America and Nippon Kayaku. There is significant market potential for an accurate, consistent test that monitors intermediate glycemic control in patients with diabetes," said Eric Button, president of BioEmerge Partners, a life science venture development firm based in Winston-Salem, NC.
Current research is focused on the ability of GlycoMark(TM) to measure postprandial hyperglycemia (after-meal glucose levels) in diabetic patients. Control of postprandial hyperglycemia is the subject of intensive pharmaceutical/academic research and development.
For more information on the GlycoMark(TM) test please visit http://www.glycomark.com/.
Close Monitoring is Key to Managing Diabetes:
Approximately 17 million people in the United States, or 6.2% of the population, have diabetes. While an estimated 11.1 million have been diagnosed, unfortunately, 5.9 million people (or one-third) are unaware that they have the disease. The Diabetes Control and Complications Trial (DCCT) and additional studies have clearly demonstrated that the key to reducing serious complications is to maintain near-normal blood glucose levels. Both glucose testing and average glucose measurements are key parameters that provide effective means to achieve effective control of diabetes.
About Nippon Kayaku and Tomen America Inc:
Nippon Kayaku is a Japanese pharmaceutical / specialty chemical manufacturer. Bleomycine was introduced as an anti-cancer drug in 1969 as an initial breakthrough. The company has since developed a powerful product line in the pharmaceutical arena and their products are being distributed to over 80 countries around the world including the U.S.
Tomen America Inc. is the principal U.S. subsidiary of Tomen Corporation, a major Japanese trading house, and has been actively seeking medical and biotech opportunities in the U.S.
Tomen America Inc.