FDA upholds decision not to approve PreMD’s skin cholesterol test

TORONTO A decision by the Food and Drug Administration to not approve an expanded use for a skin cholesterol test caused maker PreMD’s shares to fall by more than 50 percent Monday, according to Reuters.

The FDA’s decision affirmed a ruling it made in January, in which it cited defects in the design and data analysis of a study used to support the expansion.

The company had tried to overturn the FDA’s initial ruling, which concluded that its clinical trial data were not sufficient to show that the test was “substantially equivalent” to approved cardiovascular risk tests.

The company’s shares were worth 14 Canadian cents Monday. Earlier in the day, they had fallen below 10 Canadian cents.