Test for Newborn Cytomegalovirus Infection Approved by FDA

A new test to assist with detecting cytomegalovirus (CMV) in newborns less than 21 days of age just received US Food and Drug Administration (FDA) approval.

More than half of adults will have been infected with CMV by the time they reach age 40, according to the US Centers for Disease Control and Prevention (CDC). Most of those who are infected will not have any symptoms. Congenital cytomegalovirus, on the other hand, can cause hearing problems, vision loss, microcephaly, developmental and motor delay, and seizures.

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

“Although most people who become infected with CMV 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, MD, PhD, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health said 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 the 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.

Furthermore, a total of 34 samples of archived specimens from newborns known to be infected with CMV were correctly identified as positive for the virus through the Alethia CMV Assay Test System.

The FDA reviewed the CMV test through a de novo premarket review pathway, which is used for novel, low-to-moderate risk devices.

Although there is no approved vaccine to protect against CMV, earlier this fall, results from a first-in-humans dose-ranging, controlled, observer-blinded phase 1 trial for a new CMV vaccine (VBI-1501A, VBI Vaccine) revealed the vaccine was not found to be associated with any clinically significant adverse events and the vaccine is immunogenic. Next steps for the vaccine candidate are still in discussions.

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

An earlier version of this article, “FDA Approves Test for Newborn Cytomegalovirus Infection,” originally appeared on MD Magazine.com.