PreMD (Toronto), a predictive medicine company, is seeking FDA 510(k) approval of an expanded claim for its skin cholesterol test, Prevu, thus offering the possibility of a test in the U.S. that would cost no more than a blood test for LDL levels. Such an assay also could be used as an indicator of coronary artery disease, cerebrovascular disease or peripheral artery disease in patients with no known symptoms.

Approval of the broader claim would make the Prevu point-of-care test the “first cost-effective, noninvasive test on the market,” PreMD says, to aid in the assessment of carotid wall thickness and the presence of carotid plaques, which are established markers foretelling increased risk of heart attack and stroke.

PreMD’s “objective is to aim broadly,” Dr. Brent Norton, president/CEO of PreMD, told Diagnostics & Imaging Week.

It would be a broad screening tool for one of the most lethal killer diseases and one of the biggest causes of disability and loss of quality of life in the U.S. — heart disease and stroke.

The Prevu skin cholesterol test is already cleared in the U.S., Canada and Europe for those considered to be at risk for heart disease, such as those with the telltale symptom/behaviors as high blood pressure, high cholesterol, diabetes or smoking.

According to the company, Prevu non-invasively measures the amount of cholesterol (sterol) that has accumulated in the skin tissues, as opposed to requiring a blood test — and the need for the invasion of skin to gather blood. No fasting or other patient preparation is needed for the test, as is required for a blood test for cholesterol levels.

The test is conducted by placing a drop of digitonin — which “binds selectively to the cholesterol in the skin,” the company says — on the palm of a person’s hand. A second color is added after one minute, containing a substrate for digitonin. When these are combined, a blue color results, which is read after two minutes with a spectrophotometer. The precise blue color correlates to the amount of digitonin that is bound to skin cholesterol and provides results.

PreMD said that clinical studies have shown that as cholesterol accumulates on artery walls, it also accumulates in other tissues, including the skin. High levels of skin sterol are correlated with higher incidence of coronary artery disease.

The company’s submission to the FDA included data from the Predictor of Advanced Subclinical Atherosclerosis (PASA) study, which examined the relationship between Prevu POC and carotid intima media thickness (CIMT), a relationship that has been established and is “unequivocal,” Norton told D&IW.

“An expanded health claim could dramatically increase the market potential of PreVu POC and provide the healthcare community with an inexpensive tool that could save lives,” Norton said in a statement. “Our discussions with potential marketing partners are advancing and the compelling PASA data used in the 510(k) helps to underpin the importance and value of the Prevu product line.”

While Norton said he is “not at liberty” to disclose market projections that may have been developed by potential partners, he cited published reports suggesting that 300 million tests are completed annually in the U.S. to determine the level of high cholesterol counts.

And while there are other markers and tests on the market that can indicate coronary artery disease and the likelihood of a cardiac event, Norton said healthcare providers “would never screen with a multi-hundred-dollar blood test.”

In contrast, the Prevu POC test would likely cost in the $10 to $20 range per test, he said.

Clearance of the additional claim “opens [the test] to a complete broad screening claim,” Norton said, and offers to the company a “significant expansion of the market.” That expanded claim, if granted, would “increase the value equation” for the test with marketing partners. PreMD said it is in “advanced discussions” with these potential partners.

In September, the company reported that the license, development and supply agreements with McNeil Consumer Healthcare (Guelph, Ontario) for the Prevu test would terminate in three months, or in December.

As a result, PreMD was to reacquire all worldwide rights for the Prevu family of skin sterol tests, saying it would pursue other opportunities to commercialize the products.

At the time, Norton said that PreMD had been advised of a “change in strategic focus,” but that McNeil would continue to support Prevu for a period of three months.

In May, PreMD received a Notice of Allowance from the U.S. Patent and Trademark Office for the patent titled “Direct Assay of Cholesterol in Skin Samples Removed by Tape Stripping.”

Also in May, PreMD reported that it had received a letter from the American Stock Exchange stating that the exchange had determined that the company was not in compliance with certain listing standards. PreMD was to have submitted a business plan to AMEX by May 24 advising as to what action it would take to achieve compliance within 18 months.

In March, the company reported an agreement with Midsummer Investment for a private placement of about 2.9 million units at C$1.33 per unit ($1.14) for proceeds of about C$3.8 million. The company concluded that transaction in March.

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