FDA OKs First Diagnostic Aid for Congenital Cytomegalovirus

Megan Brooks

December 03, 2018

The US Food and Drug Administration (FDA) has approved a new diagnostic test to help detect cytomegalovirus (CMV) in newborns younger than 21 days old.

The Alethia CMV Assay Test System (Meridian Bioscience) detects CMV DNA from a saliva swab. It should only be used in conjunction with the results of other diagnostic tests and clinical information, the FDA stressed.

Data from a prospective clinical study showed that 1472 out of 1475 saliva samples collected from newborns were correctly identified by the test as negative for the presence of CMV DNA. 

Three samples were incorrectly identified as positive when they were negative, the FDA said.

In addition, the test correctly identified the presence of CMV DNA from 34 samples of archived salvia specimens from babies known to be infected with CMV.

CMV a Risk to Newborn Babies

"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, FDA Center for Devices and Radiological Health, said in a news release.

"This test for detecting the virus, when used in conjunction with the results of other diagnostic tests, may help healthcare providers more quickly identify the virus in newborns and determine the best approach for the child," added Stenzel.

Congenital CMV is well recognized as a common endemic congenital infection, infecting over 30,000 newborns each year in the United States.

Although many newborns congenitally infected with CMV may have no symptoms or sequelae, up to 8000 each year will have in utero growth restriction; petechiae; liver and spleen disease; thrombocytopenia; congenital and progressive hearing loss; vision loss; brain maldevelopment syndromes; microcephaly; and permanent neurodevelopmental and motor disabilities such as cerebral palsy.

In addition, fetal and neonatal death from in utero CMV occurs in approximately 400 babies each year.

The FDA reviewed the Alethia CMV Assay Test System through the de novo premarket review pathway, a regulatory pathway for some new types of low- to moderate-risk devices.

Along with this authorization, the FDA is establishing "special controls" that set forth the agency's expectations in assuring the accuracy, reliability, and effectiveness of tests intended to be used as an aid in the diagnosis of congenital CMV infection. 

"These special controls, when met along with general controls, provide a reasonable assurance of safety and effectiveness for tests of this type," said the agency.

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