- FDA Friday authorized a new diagnostic test to detect a type of herpes virus called cytomegalovirus (CMV) in newborns under 21 days of age who became infected during the mother's pregnancy.
- The Meridian Bioscience test uses a saliva swab to detect CMV DNA. FDA reviewed the Alethia CMV Assay Test System through the De Novo premarket pathway for new low- to moderate-risk devices.
- The test may help identify the virus in newborns more quickly so that the best treatment approach can be determined, the agency said.
Over half of adults have been infected with CMV by age 40, according to the Centers for Disease Control and Prevention. Once in the body, the virus remains for life and can reactivate, though most people show no symptoms of infection. However, CMV can cause serious health problems in some newborns and people with weakened immune systems.
About one in every 200 babies is born with congenital CMV infection, the CDC said. About one in five babies with congenital CMV infection become sick from the virus or have long-term health issues. Those problems may include hearing or vision loss, developmental and motor delay, microcephaly and seizures.
In approving the Meridian Bioscience test, FDA said it evaluated data from a clinical study that showed 1,472 out of 1,475 saliva samples collected from newborns were correctly identified as negative for the presence of CMV DNA. Five collected saliva specimens were correctly identified as positive for the presence of CMV DNA. Three negative samples were incorrectly identified as positive.
FDA also reviewed data from testing of 34 archived specimens from babies known to be infected with CMV in which all of the samples were correctly identified as positive for presence of CMV DNA.
FDA said it is establishing criteria for demonstrating accuracy, reliability and effectiveness of tests to be used in the diagnosis of congenital CMV infection. The special controls, when met along with other general controls, will assist in providing a reasonable assurance of safety and effectiveness for tests of this type, the agency said.
Results of the Alethia CMV Assay test are intended for use only in conjunction with the results of other diagnostic tests and clinical information.