ALBUQUERQUE, N.M., July 28, 2011 /PRNewswire/ -- VeraLight Inc., a privately held medical device company, today announced its SCOUT DS® Device was granted CE Mark approval for noninvasive diabetes screening. The easy to operate device needs no blood, does not require fasting, and yields an immediate result. The patient simply places their forearm onto the portable table-top unit and a quantitative result is reported in about three minutes.
Data from 421 study subjects in the CE filing shows SCOUT DS identified over 60% more people with abnormal glucose tolerance than either the fasting plasma glucose or hemoglobin A1c tests at thresholds established by The World Health Organization. The CE Mark filing was supported by safety and effectiveness studies on a cohort of 738 study subjects. SCOUT DS is Indicated for Use for the noninvasive screening of individuals 18 years or older who are at risk for prediabetes and/or type 2 diabetes to determine whether diagnostic testing is necessary. Prediabetes is defined as impaired glucose tolerance.
"SCOUT DS is an efficient, cost-effective alternative to established blood-based screening methods and we are excited to begin sales in key markets where the need for clinic-based and mass population screenings have been well-recognized by the national health systems and healthcare economists," says VeraLight CEO David Van Avermaete.
SCOUT DS measures skin fluorescence using proprietary technology to detect biological markers found in skin related to cumulative glycemic exposure, oxidative stress and microvascular changes. A proprietary algorithm adjusts for variations in skin tone and transforms the measured skin fluorescence and reflectance into a SCOUT Diabetes Score. Over 10,000 patients have been measured on the SCOUT DS during its technology development.
The CE Mark approval is proof of conformity that certifies the product meets European safety, effectiveness, and quality requi