ALBUQUERQUE, N.M., Oct. 3 /PRNewswire/ -- VeraLight, Inc., a privately held medical device company, today announced that it has received a Notice of Allowance from the U.S. Patent and Trademark Office for the company’s patent application (No. 10/972,173), covering proprietary dermal fluorescence technology for its non-invasive screening system to detect diabetes and pre- diabetes. Slated for market introduction in early 2008, the desktop instrument will be able to detect abnormal concentrations of diabetes-related biological markers found in skin in less than one minute using fluorescent light from an individual’s forearm -- regardless of skin color. Unlike the fasting plasma glucose (FPG) test, the device does not require a blood draw or an overnight fast prior to testing.
“VeraLight’s mission is to become the leading provider of non-invasive screening, monitoring and diagnostic products that enable the earliest detection of diabetes so therapies can be initiated to treat the disease and its complications,” said David Van Avermaete, VeraLight’s chief executive officer. “The allowance of our claims enables VeraLight to secure its proprietary position and further enhance our corporate value toward realizing this vision.”
Addressing the Problem of FPG False Negatives
Numerous studies have shown the FPG test fails to identify diabetes in approximately 50% of subjects, and its ability to detect pre-diabetes is significantly worse. Because of FPG’s false negatives, it’s not obvious that one can miss detection unless a more sensitive test is performed concurrently. Thus many individuals are not identified and treated until diabetes is well developed -- often until they present with frank symptoms 5-to-9 years into the disease with one or more, often irreversible, complications.
Results from recently announced scientific studies have shown VeraLight’s diabetes screening system -- code-named “Scout” -- was able to significantly outperform the FPG test and the A1C test for identifying diabetes and pre- diabetes in individuals with one or more known risk factors for the disease. Against the results of a two-hour oral glucose tolerance test used for validation, a prototype of the device was able to identify 29% more patients than the FPG test and 17% more patients than the A1C test. Both the FPG and A1C are blood tests used to screen patients at risk for diabetes.
Skin Biomarkers Predict Diabetes and Its Complications
VeraLight’s diabetes screening system is based on the presence of advanced glycation endproducts (AGE) in skin, and promises a more accurate and convenient method for detecting type 2 diabetes and pre-diabetes. Previous studies have shown AGE are biological markers that correlate well with diabetes and are a predictor of the disease’s serious complications. Analogous to a “diabetes odometer,” AGE are a sensitive metric for the cumulative damage the body has endured due to the effects of abnormally high blood sugar and oxidative stress. They affect the proteins that make up blood vessels, connective tissue and skin, and are thought to be major factors in aging and age-related chronic diseases.
VeraLight’s Diabetes Screening System
The product of VeraLight’s proprietary SAGE(TM) (Spectroscopic Advanced Glycation Endproducts) detection technology, Scout is a portable, desktop system weighing about 10 pounds. After the subject places the palm side of their forearm onto the system, the device shines various wavelengths of light onto the skin that causes the AGE to emit a fluorescent light signature that indicates diabetes risk. The instrument optically calibrates for skin pigmentation so that performance is not diminished by skin coloration. A specially designed fiber-optic probe couples the excitation light to the subject and relays resulting skin fluorescence to a detection module. The system’s software utilizes multivariate statistical techniques that are applied to the emitted light spectra to obtain a diabetes risk score. Total measurement time is about a minute.
About VeraLight
VeraLight, based in Albuquerque, is a privately held medical instrumentation company applying its proprietary SAGE technology to develop the first non-invasive diabetes screening system that provides healthcare professionals with a more accurate and convenient method for detecting type 2 diabetes and pre-diabetes based on the presence of biomarkers found in skin. See http://www.veralight.com for more information.
VeraLight, Inc.
CONTACT: David Van Avermaete, CEO of VeraLight, +1-925-895-5308 ordavid.vanavermaete@veralight.com; or Charles Versaggi, Ph.D., of VersaggiBiocommunications(R), +1-415-806-6039 or cv@versaggibio.com, for VeraLight
Web site: http://www.veralight.com/
