Compelo Medical Devices - Latest industry news and analysis is using cookies

We use them to give you the best experience. If you continue using our website, we'll assume that you are happy to receive all cookies on this website.

ContinueLearn More

FDA clears Roche automated Elecsys Vitamin D assay

The US Food and Drug Administration (FDA) has approved Roche's automated Elecsys Vitamin D assay for use on cobas modular analyzer platforms.

The Elecsys Vitamin D assay, which measures both vitamin D2 and D3 levels, provides results using the company’s patented electrochemiluminescence detection technology.

Roche said vitamin D is a building block for human health and is mainly produced in the skin by exposure to sunlight.

In addition to bone metabolism disorders, Vitamin D deficiency can also cause cancer, cardiovascular and diabetes diseases.

Roche Diagnostics chief operating officer Daniel O’ Day said the demand for vitamin D testing in the US is increasing, 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," Day added.