FDA clears first ever test that aids in the detection of cytomegalovirus in newborn

The US Food and Drug Administration announced Friday that it had completed the de novo premarket review and cleared Meridian Bioscience's cytomegalovirus assay for marketing for newborns less than 21 days of age.

The Alethia CMV Assay Test System detects CMV deoxyribonucleic acid (DNA) from a saliva swab from the newborn, but the diagnosis is confirmed after taking into consideration the results of other diagnostic tests and clinical presentation. 

The FDA clearance was based on results of a prospective clinical trial which showed that Alethia test correctly identified 1,472 out of 1,475 saliva samples collected as negative for CMV. Only three samples were incorrectly identified as positive when they were negative, the FDA said.

Further, the test correctly identified 34 archived samples from babies known to be infected with CMV as positive for the virus.

“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, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health in a news 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,” he further added.

 In the US, about 50% of adult get CMV infection by the time they reach the age of 40. Once a person is infected with the virus, the virus stays there for life and can be reactivated. Most people with CMV infection do not experience any symptoms, but the virus can cause serious illness in some newborn, adults, and immunocompromised population. 

CMV is the most common cause of congenital infection worldwide, and its prevalence varies between 0.2 % and 2.2 % of all infants born. In the US, about 30,000 babies are born each year with congenital CMV infection. Most babies with congenital infection do not show any signs of infection and do not have any sequelae of CMV infection in later life.

About 8000 babies are born with in utero growth restriction (IUGR), liver and spleen disease, petechiae, thrombocytopenia, congenital and progressive hearing loss, vision loss, brain maldevelopment syndromes, microcephaly, and permanent neurodevelopmental and motor disabilities such as cerebral palsy.

Severe in utero infection leads to the death of about 400 still-births every year.

FDA press release

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