SAN DIEGO, July 17 /PRNewswire/ -- VeraLight, Inc., today reported interim results of a large-scale pivotal clinical trial showing its Scout DS(TM) diabetes screening system outperformed both the fasting plasma glucose (FPG) test and the A1C test as a rapid, non-invasive screen for pre-diabetes and type 2 diabetes. The results are consistent with an earlier study and show that the desktop device outperformed FPG by 27% and A1C by 22%. Scout DS is a one-minute experimental diabetes screening system that uses light to detect diabetes-related biomarkers found in skin regardless of color. VeraLight is headquartered in Albuquerque, New Mexico.
The Scout DS is being previewed at the 2007 Clinical Lab Expo, co-sponsored by the American Association for Clinical Chemistry and the American Society for Clinical Laboratory Science, held at the San Diego Convention Center from July 17th to July 19th. The investigational device, not yet approved for marketing in the United States, is designed for use at physician-supervised point-of-care locations. The medical device is slated for U.S. market introduction in the second half of 2008.
Novel Device Shows Promise of Earlier Diabetes Detection
In 2005 the Federal government spent nearly $80 billion, or 12 percent of the total U.S. healthcare budget to treat diabetes. Of this, only $4 billion was spent on disease prevention, according to a recent federal briefing. "Our data continue to confirm that Scout DS can screen for diabetes and pre-diabetes earlier than conventional tests," said David Van Avermaete, CEO of VeraLight. "We believe this is a potentially new and important tool for diabetes prevention that can have a major impact on the economic as well as health outcome of this worldwide epidemic."
The Scout DS is currently undergoing a large-scale pivotal trial in the United States. A calibration trial of 1,850 subjects at risk for type 2 diabetes has completed data collection at eight U.S. sites. This phase of the trial is designed to assure its ability to predict abnormal glucose tolerance in a wide range of individuals. Interim results based on 853 subjects at four clinical trial sites (San Diego, Minneapolis, Chicago and Washington, D.C.), showed the diabetes screening system had a sensitivity of 71% for detecting abnormal glucose tolerance. In contrast, the FPG test had a sensitivity of 56% and the A1C test had a sensitivity of 58%. All measurements were made at a 20% false positive rate.
In August 2007, Scout DS will be undergoing further testing at 20 U.S. sites with 4,000 subjects at risk for type 2 diabetes. In all cases, the device is being compared to the gold standard Oral Glucose Tolerance Test (OGTT) as the reference method.
Bloodless Diabetes Screening
Weighing about 10 pounds, Scout DS is a simple-to-use device that does not require the patient to fast or provide a blood sample. Using light directed onto a small area of an individual's forearm the device is able to detect abnormal concentrations of advanced glycation endproducts (AGEs), which correlate well with diabetes and pre-diabetes and are associated with the disease's serious complications.
After the subject places the palm-side of the forearm onto the cradle of the Scout DS, the device shines multiple wavelengths of light into the skin causing AGEs to emit fluorescent light that is measured by the machine. The instrument compensates for skin pigmentation so that performance is not diminished by skin coloration. The system's software utilizes multivariate statistical techniques that are applied to the spectra to obtain a diabetes risk score. As with all diabetes screening methods, an additional test is required to confirm diagnosis. The recommended confirmation for Scout DS is an OGTT.
Analogous to a "diabetes odometer," AGEs are a sensitive metric for the cumulative damage the body endures due to the effects of abnormally high blood sugar and oxidative stress. AGEs harm the proteins that make up the blood vessels, connective tissue, and are thought to be major factors in aging and age-related chronic diseases. According to medical experts, non-invasive skin detection of AGEs could replace the FPG test as the medical workhorse for screening people suspected of having diabetes.
Poor Performance of Conventional Screening Tests
Conventional diabetes screening methods such as the FPG and the OGTT are inconvenient and often perform poorly. Diagnosis of diabetes typically doesn't occur until 7-9 years post onset when 50% of patients have one or more irreversible complications. The FPG requires a fasting blood sample; and the OGTT test requires fasting, ingestion of a glucose load, and multiple blood samples. Due to poor sensitivity, the FPG misses up to 60% of the people, and the OGTT suffers from poor reproducibility with a Coefficient of Variation of up to 18%. These deficiencies can lead to false-negative or inconsistent results and add to the undiagnosed problem.
Need for Early and More Accurate Diabetes Screening
The World Health Organization estimates there will be 221 million cases of diabetes by 2010. More than 73 million Americans -- one third of the adult population -- now have diabetes or may be on their way to getting it, according to a NIDDK study published in the June 2006 issue of Diabetes Care. The study showed 9.3 percent of adults age 20 and older (19.3 million people) had diabetes in 1999-2002.
VeraLight, Inc., based in Albuquerque, New Mexico, 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. For more information see http://www.veralight.com.