WILLOW GROVE, Pa.--(BUSINESS WIRE)--NMS Labs announces its launch of chromium and cobalt testing in blood, serum/plasma, and urine to help determine metal exposure in patients who have been implanted with recalled metal hips. Patients are at risk to exposure to chromium and cobalt components of the implants due to the rubbing together of metal-on-metal components. Such exposure can increase the body burden of these metals. Bio-monitoring of these metals may assist in the prevention of potential toxicities.
NMS Labs chromium and cobalt test is being offered at a crucial time. The United States Food & Drug Administration (FDA) recently ordered manufacturers and Contract Research Organizations (CROs) to conduct post-market surveillance studies on metal-on-metal hip system exposure cases. The agency is requiring manufacturers to submit research protocols that address specific safety issues related to metal devices. Data from the studies will enable the FDA to better understand these devices and their safety profiles.
NMS Labs developed its test in response to the recall of hip-replacement products that have been found to elevate the body's levels of chromium and cobalt. The test was designed following the specifications required in the recall testing. These specifications include ICP-MS methodology and a lower limit of detection.
Regarding the innovative and timely test, NMS Labs' Medical Director, G. John DiGregorio, M.D., Ph.D., commented, “In the clinical arena, the ability to detect chromium and cobalt in multiple sample types is a major advancement in the science of assessing heavy metal exposure. For patients with metallic implants, the availability of testing in urine specifically provides a simple means of tracing chromium and cobalt without going through an invasive blood analysis.”
About NMS Labs:
NMS Labs is a national reference laboratory that is unsurpassed in its scope of toxicology tests, accuracy of results, scientific expertise, and innovation. NMS Labs is passionate about promoting public health and safety. For more information on NMS Labs, please visit www.nmslabs.com.