Meridian Bioscience has secured authorisation from the US Food and Drug Administration (FDA) to market a new test for the detection of cytomegalovirus (CMV) in newborns.
The new Alethia CMV Assay Test System is designed to identify CMV deoxyribonucleic acid (DNA) from saliva swabs to diagnose congenital CMV infection.
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A report by the US’ Centre for Disease Control and Prevention (CDC) showed that more than 50% of adults have had a CMV infection by age 40. While the majority of infected people do not display signs or symptoms, those with weakened immune systems and newborns may experience serious health issues.
The FDA’s office of in-vitro diagnostics (IVD) and radiological health director Tim Stenzel said: “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.
“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.”
The FDA reviewed Alethia CMV Assay Test System’s analytical and clinical data, including findings from a prospective clinical study.
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By GlobalDataDuring the study, the device was able to correctly detect 1,472 out of the total 1,475 saliva samples from newborns as negative for CMV DNA. Three specimens were incorrectly identified and five were correctly detected as positive for the presence of the DNA.
The regulatory agency also evaluated results from 34 samples of archived specimens from babies with known CMV infection. The device was able to correctly identify all the specimens as positive.
