Roche announced on Wednesday that they have received clearance from the U.S. Food and Drug Administration to go ahead with a fully automated vitamin D test for use on their cobas modular platforms.
Market Watch reports that the test will help to expand Roche’s bone metabolism test menu. Vitamin D is an incredibly important building block for humans, and is mainly produced by exposure to sunlight. Bone metabolic disorders have been linked to vitamin D deficiency, as well as other diseases, such as cancer, cardiovascular disease, and diabetes.
Daniel O’ Day, chief operating officer of Roche Diagnostics, stated:
“The demand for vitamin D testing in the U.S. is increasing rapidly, and having a large installed base of cobas analyzers will allow labs to easily respond to that demand and integrate the Roche test into their existing workflow. Adding this test enables them to offer precise and accurate results to help clinicians assess vitamin D sufficiency in adult patients so they can provide optimal care.”
According to iStock Analyst, the Elecsys vitamin D assay will measure both vitamin D2 and D3, which is important for doctors to measure on people who are taking different forms of vitamin D supplements. The test results will be obtained while using Roche’s patented ECL (electrochemiluminescence) detection technology. The ECL is good, because it provides a broad measuring range, and also has high precision at the low end of detection, which will help when assessing severely deficient patients.
There are currently more than one billion people who suffer from vitamin D deficiency.