The FDA granted marketing authorization to Meridian Bioscience Inc. for the Alethia CMV Assay Test System to aid in detecting cytomegalovirus in newborns less than 21 days of age.
Used as an aid in the diagnosis of congenital cytomegalovirus (CMV) infection by detecting CMV DNA from a saliva swab, test results from the Alethia CMV Assay Test System should be used only in conjunction with results of other diagnostic tests and clinical information, according to a press release from the FDA. In an evaluation of the device’s analytical and clinical performance, FDA found the Alethia CMV Assay Test System correctly identified 1,472 saliva samples of 1,475 samples collected from newborns as negative for the presence of CMV DNA. The release noted the test incorrectly identified three samples as positive when they were negative and correctly identified five collected saliva specimens as positive for the presence of CMV DNA. In addition, the test correctly identified 34 samples of archived specimens from babies known to have CMV as positive for presence of CMV DNA, according to the release.
“Although most people who become infected with cytomegalovirus face little to no risk of serious illness, the virus has the potential to cause serious illness for people with weak immune systems and in newborn babies,” Tim Stenzel, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health, said in the release. “This test for detecting the virus, when used in conjunction with the results of other diagnostic tests, may help health care providers more quickly identify the virus in newborns and determine the best approach for the child.”