FDA Approves Test for Newborn Cytomegalovirus Infection

The US Food and Drug Administration (FDA) has approved marketing of a new test to assist with detecting cytomegalovirus (CMV), a type of herpes virus, in newborns less than 21 days of age.

The Alethia CMV Assay Test System assists in the diagnosis of congenital cytomegalovirus by detecting CMV deoxyribonucleic acid (DNA) from a saliva swab. Results from the test are intended to be used in tandem with results from other tests as well as clinical information.

By age 40, over half of adults have been infected with cytomegalovirus, according to the US Centers for Disease Control and Prevention (CDC), and most people infected have no symptoms of infection. However, congenital cytomegalovirus, which occurs when a fetus is infected with the virus can cause hearing problems, vision loss, microcephaly, developmental and motor delay, and seizures.

“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,” said Tim Stenzel, MD, PhD, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health, in a statement. “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.”

The FDA’s decision to approve the Alethia CMV Assay Test System was supported by data from a prospective clinical study. In this study, 1472 of 1475 samples of newborns’ saliva were correctly identified as negative for the presence of CMV DNA. The other 3 samples were incorrectly identified as positive for CMV DNA. There were 5 saliva samples correctly identified as positive for CMV DNA.

The FDA also reviewed data from the testing of archived specimens from newborns known to be infected with CMV. The Alethia CMV Assay Test System correctly identified all 34 of these archived samples as positive for CMV DNA.

In utero HIV infection has been linked to an increased risk of congenital cytomegalovirus. These infants have a 23% chance of acquiring congenital cytomegalovirus and are more likely than infants not infected with HIV to have symptomatic CMV.

The FDA reviewed the CMV test through a de novo premarket review pathway, which is used for novel, low-to-moderate risk devices. This decision has also created a new regulatory classification, meaning that any similar devices of the same type with the same intended use may use the FDA’s 510(k) process to receive marketing authorization by demonstrating substantial equivalence to a previously approved device.

Meridian Bioscience, Inc. has received marketing authorization for the Alethia CMV Assay Test System.