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
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