Therapy Areas: Devices
US FDA clears the first Alethia CMV Assay Test System in detecting cytomegalovirus herpes virus in newborns
3 December 2018 -

Public health agency The US Food and Drug Administration announced on Friday that it has approved the marketing of a new diagnostic test, the Alethia CMV Assay Test System, to aid in detecting the cytomegalovirus (CMV) herpes virus in newborns less than 21 days of age through the de novo premarket review pathway.

The US FDA has granted marketing authorisation of the Alethia CMV Assay Test System to Meridian Bioscience Inc.

According to the company, the Alethia CMV Assay Test System is used as an aid in the diagnosis of congenital CMV infection by detecting CMV deoxyribonucleic acid (DNA) from a saliva swab. The test results should be used only in conjunction with the results of other diagnostic tests and clinical information.

In conjunction, the US FDA evaluated the analytical and clinical performance of the device based on the data from a prospective clinical study,which showed that 1,472 saliva samples out of 1,475 samples collected from newborns were correctly identified by the device as negative for the presence of CMV DNA. Three samples were incorrectly identified as positive when they were negative. Five collected saliva specimens were correctly identified as positive for the presence of CMV DNA.

Congenital CMV occurs when a baby is infected with CMV during pregnancy. Although most babies with CMV will not have any signs or symptoms of infection, some babies can develop hearing problems or other long-term health problems.

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