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 term."
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 risk score.
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