FDA approves Alethia CMV Assay Test System for diagnosing cytomegalovirus.- Meridian Bioscience.

The FDA has permitted marketing of the Alethia CMV Assay Test System, from Meridian Bioscience, to aid in detecting a type of herpes virus called cytomegalovirus (CMV) in newborns less than 21 days of age. 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. Test results should be used only in conjunction with the results of other diagnostic tests and clinical information. The FDA reviewed the Alethia CMV Assay Test System through the de novo premarket review pathway, a regulatory pathway for novel, low-to-moderate-risk devices of a new type.

The FDA evaluated the analytical and clinical performance of the device. Data from a prospective clinical study 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. The FDA also reviewed data from a testing of 34 samples of archived specimens from babies known to be infected with CMV in which all the archived specimens were correctly identified by the device as positive for presence of CMV DNA.

Comment: Along with this authorization, the FDA is establishing criteria, called special controls, which determines the requirements for demonstrating 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. This action also creates a new regulatory classification, which means that subsequent devices of the same type with the same intended use may go through the FDA�s 510(k) process, whereby devices can obtain marketing authorization by demonstrating substantial equivalence to a predicate device.