New Fully Automated Vitamin D Assay Submitted for FDA Clearance

Abbott files for 510(k) clearance for the ARCHITECT 25-OH Vitamin D assay

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Apr 15, 2011, 09:00 ET

ABBOTT PARK, Ill., April 15, 2011 /PRNewswire/ -- According to a recent report from the U.S. Centers for Disease Control and Prevention, a third of Americans have vitamin D levels that are either inadequate or deficient. While many people know that vitamin D is necessary to help the body absorb calcium, which helps create strong bones and muscles, many don't know that insufficient levels of this important vitamin may lead to other health problems.

"Increasing interest in vitamin D is fueling a surge in orders for tests as more health care professionals and consumers become aware of the rising prevalence of vitamin D deficiencies in otherwise healthy people and the potential health risks," said Sudarshan Hebbar, M.D., senior medical director, Diagnostics, Abbott.

To help physicians manage growing demand for vitamin D testing, Abbott announced today it filed a submission for clearance by the U.S. Food and Drug Administration for a fully automated vitamin D assay performed on its widely used ARCHITECT testing system.

The ARCHITECT 25-OH Vitamin D assay is a fully automated immunoassay. It is intended to help laboratories manage their increasing vitamin D testing volumes through the quantitative determination of 25-hydroxy vitamin D in human serum and plasma to aid in the assessment of vitamin D sufficiency. 25-hydroxy vitamin D is the body's repository of vitamin D and is established as the appropriate measurable indicator of vitamin D status.

Low vitamin D also can cause skeletal disorders, such as rickets in children and osteopenia 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 vitamin D deficiency may increase the risk for cardiovascular problems, autoimmune disorders and some infectious diseases.

According to the Institute of Medicine of the National Academy of Science, most adults should get 600 international units (IUs) of vitamin D daily instead of the previously recommended 400 IUs. In addition, higher doses of 800 IUs are better for anyone age 70 and older. While healthcare practitioners agree that vitamin D is essential for bone health, they also believe patients should be tested regularly.

"Research shows that vitamin D levels are a concern for patients with osteoporosis, chronic kidney disease, malabsorption, and anyone with a condition or taking a medication that may impair bone health," said Brian Blaser, senior vice president, Diagnostics, Abbott. "This new fully automated vitamin D assay may help physicians better diagnose and counsel patients with suspected vitamin D deficiency."

About Abbott Diagnostics

Abbott is a global leader in in vitro diagnostics and offers a broad range of innovative instrument systems and tests for hospitals, reference labs, molecular labs, blood banks, physician offices and clinics. With more than 69,000 customers in more than 100 countries, Abbott's diagnostic products offer customers automation, convenience, bedside testing, cost effectiveness and flexibility. Abbott has helped transform the practice of medical diagnosis from an art to a science through the company's commitment to improving patient care and lowering costs.

About Abbott

Abbott (NYSE: ABT) is a global, broad-based health care company devoted to the discovery, development, manufacturing and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs nearly 90,000 people and markets its products in more than 130 countries.

Abbott's news releases and other information are available on the company's website at www.abbott.com.

SOURCE Abbott