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FDA approves congenital CMV diagnostic test


 

The Food and Drug Administration has permitted marketing of the Alethia CMV Assay Test System, a new test to be used as an aid in the diagnosis of congenital cytomegalovirus (CMV) in newborns less than 21 days of age.

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The Alethia CMV Assay Test System detects CMV DNA from a saliva swab. Results from the test should be used only in conjunction with the results of other diagnostic tests and clinical information, according to an FDA statement.

“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,” said Timothy Stenzel, PhD, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health.

In a prospective clinical study, 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.

In a testing of 34 samples of archived specimens from babies known to be infected with CMV, all of the archived specimens were correctly identified by the device as positive for the presence of CMV DNA.

The FDA reviewed the Alethia CMV Assay Test System through a regulatory pathway established for novel, low- to moderate-risk devices. Along with this authorization, the FDA is establishing criteria, called special controls, which determine the requirements for demonstrating accuracy, reliability, and effectiveness of tests intended to be used as an aid in the diagnosis of congenital CMV infection.

With this new regulatory classification, 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 previously approved device.

The FDA granted marketing authorization of the Alethia CMV Assay Test System to Meridian Bioscience.

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