NEW YORK (GenomeWeb) – The US Food and Drug Administration announced on Friday it has completed the de novo premarket review and cleared for marketing Meridian Bioscience's cytomegalovirus assay for newborns called the Alethia CMV Assay Test System.
The Alethia brand is the new name for Meridian's molecular test line, which was previously marketed under the Illumigene and Illumipro names.
According to a statement issued today by the FDA, the Alethia CMV test system enables detection of CMV DNA from saliva swabs of newborn babies who are less than 21 days old. The FDA specified that test results must be used in conjunction with the results of other diagnostic tests and clinical information.
"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, the director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health.
Specifically, more than half of all adults have been infected with CMV by age 40, according to the US Centers for Disease Control and Prevention, but most show no signs or symptoms. However, babies infected with CMV in utero can develop hearing problems or other long-term health problems.
A prospective clinical study showed the Alethia test correctly identified 1,472 out of 1,475 CMV negative samples, the FDA said. There were three false positive tests, and five saliva specimens correctly identified as positive. Meanwhile 34 archived positive specimens were also correctly identified.
The FDA further noted that the de novo authorization creates a new regulatory classification, "[w]hich 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."