FDA clears Abbott's new ARCHITECT 25-OH Vitamin D assay

Abbott (NYSE: ABT) announced today it has received clearance from the U.S. Food and Drug Administration for a fully-automated 25-OH Vitamin D assay performed on its widely used ARCHITECT^® laboratory testing platform.

Published data from the Third National Health and Nutrition Survey, reported in the Archives of Internal Medicine, show that less than a quarter of Americans have the minimal vitamin D levels necessary for general health benefits. There are a number of factors that may contribute to people having low vitamin D, including low dietary intake, sun avoidance, geographic location, age and ethnicity.

Low vitamin D can cause skeletal disorders, such as rickets in children and bone loss in adults, and has been linked to an increased risk of hip fractures. Although research is still being conducted in this area, some studies have shown that people with a low level of vitamin D may have elevated risk for cardiovascular problems, autoimmune disorders and some infectious diseases.

"As health care professionals and patients become aware of the potential health risks associated with low vitamin D, labs have seen a surge in test orders," said Brian Blaser, senior vice president, Diagnostics, Abbott. "The new ARCHITECT 25-OH Vitamin D assay has shown excellent precision and offers a fully-automated solution that may help laboratories cope with escalating demand for vitamin D testing and help get results to physicians and their patients much sooner."

With a simple blood test, the ARCHITECT 25-OH Vitamin D assay can measure the stable form of vitamin D, 25-hydroxyvitamin D (25-OH vitamin D), the body's repository of vitamin D. In the kidneys, 25-OH vitamin D converts into the active form of the vitamin that helps regulate calcium and phosphate levels. 25-OH vitamin D is established as the appropriate measurable indicator of vitamin D status because it is stable and easily measured.

"Regular vitamin D testing can be important for people who may have risk factors that could contribute to vitamin D deficiencies," said Beth Schodin, Ph.D, scientific affairs manager, Diagnostics, Abbott. "The availability of a highly accurate and reliable vitamin D assay can give physicians timely information about their patients and help them identify appropriate treatment options."

SOURCE Abbott