Miraculins Inc., a medical diagnostic company focused on
developing and commercializing diagnostic tests and risk assessment technologies
for unmet clinical needs, announces today that it has filed a class II medical device
license application with Health Canada for the PreVu Non-Invasive Skin
Cholesterol Point of Care (POC) Test. The application, in significant part,
required that Miraculins develop an ISO 13485 certified Quality Management
System. Miraculins was issued its formal ISO Certificate of Registration by The
BSI Group Inc. on January 13, 2012.
“Receiving Health Canada
clearance for the PreVu Non-Invasive Skin Cholesterol POC test will allow us to
begin selling this important new screening tool in Canada to more effectively help
detect the hidden risk of coronary artery disease”, said Christopher J.
Moreau, President & CEO of Miraculins. “We have significantly advanced
discussions with distribution partners in a number of market segments and I
look forward to updating the market on PreVu launch plans in the near
About the PreVu Non-Invasive Skin Cholesterol Test
PreVu is a non-invasive risk assessment technology that evaluates the additional
risk a person may have for coronary artery disease (CAD) by conveniently and painlessly
testing their skin cholesterol level. High levels of skin cholesterol have been
shown to be correlated to CAD as measured by stress test, angiography, coronary
calcium, and carotid intima-media thickness, inflammatory markers of vascular disease,
previous heart attack incidents and Framingham
About Miraculins Inc.
Miraculins is a medical diagnostic development company focused on acquiring and
advancing non-invasive tests for unmet clinical needs. The Company’s PreVu test
is a revolutionary new coronary artery disease (CAD) risk assessment technology
that measures cholesterol levels in a patient’s skin non-invasively, painlessly
and without the need for fasting. PreVu has previously been successfully test
marketed in North America on a limited basis.
Miraculins additional programs include a research use only ELISA kit for the
detection of PSP94; and a suite of biomarkers to aid in the early detection of
the devastating disease of pregnancy known as preeclampsia. The Company’s
preeclampsia program is being advanced in partnership with Alere, Inc. (formerly
known as Inverness Medical Innovations), one of the world’s largest diagnostic
companies. For more information on Miraculins please visit www.miraculins.com.
PreVu Non-Invasive Cholesterol Test technology is not
currently licensed for sale in Canada.
Posted by Sean Fenske, Editor-in-Chief, MDT