How “groundbreaking” are skin cholesterol tests?

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In a week in which we already wrote about US drug stores giving out free statin drugs, we thought readers might be interested in how a new (new-ish) skin cholesterol test is being marketed, and how some Canadian drug stores are getting in on the act.

Someone in Canada sent me the following news release:

Good morning ____________

This is happening on Monday March the 25th at London Drugs, South Edmonton Common store. We can arrange for the test to be done on a reporter in about 5 minutes. There will be pharmacists conducting tests on people throughout the day.

Alberta is about to see a game-changing innovation in cholesterol testing that may motivate considerably more people to seek a full evaluation of their risk for coronary artery disease (CAD)

Developed in Canada, the new test procedure has the potential to help identify people at an increased risk of CAD both at home and abroad. It measures cholesterol in the skin, elevated levels of which have been shown in clinical studies to be strongly associated with an increased risk of significant atherosclerotic disease.

The new test is being made available to the public through special heart health clinics at London Drugs and is being rolled out across Canada throughout the year.

There are over 70,000 heart attacks in Canada each year, resulting in over 19,000 deaths. Yet people often put off having their risk factors properly and globally assessed by a healthcare provider. Many people avoid getting blood-work done due to the inconvenience factor, accessibility issues with doctors, and because they don’t suspect they are even at risk of CAD in the first place. Additionally, we all know people who avoid blood work at all costs, either because of a strong fear of needles or a distaste for fasting (or both). The problem is that, for many people, the first sign of CAD is a heart attack, all too often resulting in debilitation or death.

That may be all set to change. A revolutionary new type of cholesterol test which measures cholesterol present in the skin without a needle prick, blood draw, or fasting will soon be available to Canadians in their neighborhood pharmacies. Called the PreVu® Point of Care (POC) Test, this non-invasive skin cholesterol test – the world’s first and only such test – has been developed to help identify individuals who may be at higher, hidden risk of coronary artery disease and who could consequently benefit from global screening and preventive measures to help guard against that critical first event.

The skin contains 11 per cent of the body’s cholesterol, by weight. The ability to now conveniently measure a person’s skin cholesterol level with the PreVu POC Test introduces a valuable new biomarker for risk of CAD.  When followed by the formal evaluation of traditional risk factors (for patients deemed to be at increased risk due to their skin cholesterol levels) such as a family history of cardiovascular disease or high blood cholesterol, or being overweight, having diabetes, being a smoker, living a sedentary lifestyle or having high blood pressure, this new biomarker improves overall risk assessment for heart disease. In one clinical study – conducted at six U.S. research institutions – patients who had elevated skin cholesterol, but were considered to only be at intermediate risk of CAD according to traditional biomarkers, were found to be three to four times more likely to have evidence of cardiovascular disease.

The PreVu POC Test is not a replacement or surrogate for blood cholesterol testing. Skin cholesterol is separate and distinct from blood cholesterol and the skin cholesterol test does not predict one’s blood cholesterol level.


The PreVu POC Test is being made available to the public on an expanded basis now through special heart health clinics at multiple London Drugs locations in Western Canada, where consumers can have their skin cholesterol tested by pharmacists throughout March and early April.  Miraculins, the Canadian medical device company that owns the PreVu technology, plans to make the test available through additional pharmacy chains across the country throughout the balance of 2013. The test is also cleared for sale in the European Union and in the U.S.

Please see the press release below and let me know if you’d like to speak with a doctor, pharmacist and/or a representative of Miraculins executive management, about this ground-breaking, Canadian medical advance.

We also have video B-roll footage of a patient being administered the test or can accommodate in-pharmacy photography or videography.

Back to the first line – how thoughtful of them to ensure that a reporter could be tested so promptly.  I wonder how many bit on that offer. And the last line’s offer of video b-roll footage should give readers an idea of how marketing/PR people make it easy for television news folks to all tell the same story in the same way, as Conan reminds us.

The CBC reported, “New cholesterol skin test raises expert concerns.” Excerpt:

“A new $20 test for cholesterol that some B.C. pharmacies are introducing is stirring up controversy in the medical community.

Winnipeg bio-tech company Miraculins says the desire for fast and convenient cholesterol test results prompted the creation of their device.

It allows pharmacists to scan the palm of someone’s hand and analyze how much cholesterol is in the skin.

UBC cardiologist Dr. John Mancini sees some benefit to the convenience of the tests.

“This is like a thermometer; it tells you if you are worried and you have got a bit of a fever. It heightens the chance of you having a chat with your doctor,” he said.

But Dr. Daniel Holmes, the head of clinical chemistry as St. Paul’s hospital has his reservations.

He notes each test administered by a pharmacist costs $19.99, but a traditional blood test is covered by the province.

“I wouldn’t spend $19.99 for the test. I wouldn’t spend $1.99 for it. There are lots of people who are willing to take your money for testing that is not well scientifically validated,” he said.

Holmes says the device should not replace blood testing. He recommends anyone concerned about their cholesterol should save their money and just take the time to consult a physician.”

In this country, the FDA approved the test under the special 510(K) provision almost 7 years ago – ruling that the approach is “substantially equivalent” to other approaches already marketed and approved. Consumers should be aware of that kind of back-door, half-hearted approval provision.  But the FDA included this limitation:

“The safety and effectiveness of this device for use in screening the general population for coronary artery disease or for use as a substitute for blood cholesterol tests or a substitute for other risk factors identified for coronary artery disease have not been established.”

But is this one time when Canadian marketing is outpacing US hype?


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