Diagnostics & Imaging Week

After receiving a non-substantially equivalent letter from the FDA last month for its skin cholesterol test, Prevu, PreMD (Toronto) has now filed a request for a second level review of the 510(k) submission.

“It’s been devastating in terms of impact on company,” Brent Norton, president/CEO told Diagnostics & Imaging Week, later acknowledging that the decision puts the company in “a tough spot.”

“The market value of the company has fallen through the floor. We’ve taken all the action we can to reduce costs, including laying off one-third of the workforce. We’re a small company, so that’s just six people.”

PreMD was seeking an expanded regulatory claim on its point-of-care skin cholesterol test, suggesting that it 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.

Norton said the FDA’s primary reason for rejecting the claim relates to the clinical utility of evaluating skin cholesterol, with carotid wall intima thickness as the clinical endpoint.

PreMD submitted the 510(k) application to the FDA in June 2007, based on a study design previously accepted as appropriate by the FDA. Later, the FDA requested additional information regarding statistical clarification on the data submitted. PreMD provided the information requested and, Norton said he believes that the company adequately addressed those concerns.

Approval of the broader claim would have made Prevu the first “cost-effective” (in the $10 to $20 range), non-invasive test on the market, according to the company.

In light of the non-equivalent ruling by the agency, PreMD implemented the workforce reduction and other decreases in general and administrative expenses. The remaining key members of PreMD are concentrating their efforts on the FDA review and assessing alternatives.

“We have enough cash to meet short-term goals for the next few months,” Norton said, adding that the company is considering all options to stay afloat — from fund-raising to a possible merger. “There still is significant value to what we have going here, but we’re in a tough spot.”

PreMD says it is continuing to advance development programs for other product candidates in its oncology pipeline.

The company’s other skin cholesterol products include Prevu(x) LT, a test designed for use in the life insurance industry. The company’s cancer tests include ColorectAlert, LungAlert and a breast cancer test.

The company says it is working with AstraZeneca Pharmaceuticals (Phoenix), which licensed the Prevu test for marketing and distribution in the U.S., to fully explore the issues raised by the FDA and address the appropriate steps going forward.

Prevu is already cleared in the U.S., Canada and Europe for those considered at risk for heart disease, including people with symptoms such as high blood pressure, high cholesterol, diabetes or smoking.