NEW YORK (360Dx) – Sciex said today that it has received de novo US Food and Drug Administration clearance for its mass spec-based Vitamin D assay kit.
The test, which will be offered through the company's Sciex Diagnostics division, is the only FDA-cleared LC-MS-based Vitamin D assay kit currently on the market, Sciex said.
Called the Vitamin D 200M Assay, the kit is meant to be run exclusively on the Sciex Topaz System, an integrated LC-MS platform running Sciex's ClearCore MD clinical software.
According to Sciex, the Office of Inspector General (OIG) "recently reported Vitamin D as one of the top five laboratory assays reimbursed by Medicare, accounting for 8.7 million laboratory tests and $337 million in reimbursement dollars."
Sciex added that the US Centers for Disease Control has determined that mass spec provides more accurate Vitamin D test results than immunoassays, offering greater specificity and less cross-reactivity. The Vitamin D 200M Assay meets the CDC's Vitamin D Standardization-Certification Program criteria, the company said.
The assay "will enable clinical labs to expand their in-house testing services… as well as add to their own laboratory developed tests, Aaron Hudson, senior director and general manager of Sciex Diagnostics said in a statement.