Miraculins set to market non-invasive cholesterol test

By: Martin Cash

Posted: 03/7/2012 1:00 AM | 

After more than 18 months of development, Winnipeg medical diagnostic company Miraculins Inc. is about to take delivery of its first shipment of skin cholesterol test kits.
This year it will begin marketing the first non-invasive cholesterol test on the world market.
Company CEO Chris Moreau said the next round of announcements about the PreVu non-invasive skin cholesterol point-of-care test will be about distribution agreements and pilot projects with pharmacies.
Moreau would not quantify or predict the kind of market uptake there will be, other than to say there are 540 million blood cholesterol tests performed annually worldwide.
"There is going to be a tremendous level of interest and demand for this test," Moreau said. "It is a new marker for heart disease, something that is very difficult to screen for."
Skin contains 11 per cent of the body's cholesterol deposits. As blood vessel walls accumulate cholesterol, so do skin tissues. A high skin cholesterol level is believed to be a trusted predictor of higher cholesterol accumulation in the arteries and, accordingly, the risk of heart disease.
Miraculins worked 14 months to achieve ISO certification to satisfy Canadian and European regulators. That was achieved earlier this year.
Moreau said Miraculins is expecting the first batch of test kits in the next three weeks.
As for U.S. regulatory approval, that has been in place since Miraculins acquired the technology in September 2010. Even though its U.S. regulatory clearance is restricted to patients considered at risk, Moreau said there will still be a strong opportunity in the U.S. market.
"We are still quite excited about that U.S. regulatory clearance," he said. "We think that market is still significant, even if we have to work a little extra hard to find out if a person is considered to be at risk instead of just anybody who shows up to take the test."
There are two versions of the non-invasive test kit that do not require a blood test or fasting.
One is a point-of-care kit done on the palm of a hand that provides results in five minutes. That is expected to retail for $35 to $50.
Marketing efforts have already begun to make the kits available in pharmacies, general practitioners' offices, alternative medicine practitioners and the insurance industry.
Another format -- where cells from the palm are collected with a sterile collection device -- requires the user to send samples to a lab, with results emailed in two days.
martin.cash@freepress.mb.ca