This non-invasive test measures cholesterol in the
skin tissues to assess risk of coronary artery disease (CAD) or heart disease.
The PREVU* Skin Cholesterol Test non-invasively, painlessly and rapidly measures skin cholesterol. As a new risk factor
for heart disease, skin cholesterol provides valuable additional information to traditional CAD risk assessment. Skin contains
over 11% of the bodyï¿½s cholesterol and ages in parallel with vascular connective tissue. As arterial walls accumulate cholesterol,
so do the skin tissues. A high skin cholesterol level is a reliable predictor of higher cholesterol accumulation in the arteries and,
accordingly, can be used in combination with other risk factors to assess risk of coronary artery disease.The product has
previously received FDA clearance for sale in the United States and additional regulatory approvals in Canada and Europe.
PREVU* has been successfully test marketed on a limited basis in North America.
PREVU* Point of Care (POC) Skin Cholesterol Test is a non-invasive, painless and cost-effective tool to measure skin cholesterol that does not require any patient preparation or interruption to diet (i.e. fasting).
This simple test is conducted by placing a drop of digitonin, which binds selectively to the cholesterol in the skin, on the palm of the hand. This liquid also contains an enzyme (horseradish peroxidase) linked to the digitonin by a copolymer. After a one-minute incubation period, the area is blotted dry to remove any unbound digitonin solution. A second drop of liquid is then added, containing a substrate for the horseradish peroxidase enzyme. When combined, a blue color change occurs in direct proportion to the amount of digitonin that is bound to skin cholesterol. After two minutes, a hand-held spectrophotometer (color reader) is placed over the drop to measure the precise blue color, which indicates the skin cholesterol value.
In addition to the POC format of the test, the PREVU* technology is also being developed by Miraculins as the PREVU* LP Skin Cholesterol Test, a lab-processed format featuring a proprietary collection device. The LP format has previously been cleared for sale in Canada and Europe.
In Canada and Europe, PREVU* POC and PREVU* LP have previously been cleared for use as part of risk assessment for CAD.
In the U.S., PREVU* POC has been previously cleared for use as part of risk assessment for CAD in persons with a history of heart attack and/or in persons suspected of having clinically significant coronary artery disease (>50% stenosis, or blockage, in more than one vessel, as diagnosed by angiography). Skin cholesterol test results, when considered in conjunction with clinical evaluation, blood cholesterol and other risk factors identified for coronary artery disease, will aid the physician in focusing diagnostic and patient management options.
PREVU* POC is CLIA-exempt.
PREVU* has been successfully test marketed on a limited basis in North America prior to Miraculins acquisition of the technology.
As Miraculins works toward product re-launch, the Company is actively seeking marketing and distribution partners to make the PREVU* products available to patients and health care professionals worldwide. Opportunities include marketing and distributing the skin test into the healthcare community, including physician offices, hospitals, retail chains, corporate risk assessment services and other institutions and promoting PREVU* products to the life-insurance industry and other future applications of the technology under the PREVU* brand including direct to the consumer marketing.
For information about Marketing and Distribution, please contact Miraculins business development team. Contact information here.
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