FDA has expanded the emergency use authorization (EUA) of the Aptima Zika virus diagnostic assay from Hologic Inc, Marlborough, Mass. The assay is now authorized to be used with urine samples collected alongside patient-matched serum or plasma specimens.
Hologic’s Zika virus assay was authorized for emergency use with serum and plasma samples in June 2016. Its new use with urine samples lengthens the period during which patients can be tested for Zika from 7 days to 14 days following the onset of symptoms, as recommended by the US Centers for Disease Control and Prevention.
“This action by FDA is significant because it gives many more people the opportunity to be tested with our highly sensitive assay,” says Tom West, division president of diagnostic solutions at Hologic. “In particular, this expanded indication allows us to better serve public health labs, increasing access to more people to detect and diagnose more disease.”
The Aptima Zika virus assay runs on Hologic’s Panther system, an integrated system that fully automates all aspects of nucleic acid amplification testing. By reducing hands-on time, the Panther system helps to minimize labor needs and the potential for manual errors. The Aptima Zika virus assay is available for use in all 50 states, Puerto Rico, and US territories.
“We are driven to provide solutions to some of society’s most urgent unmet health needs,” says Steve MacMillan, chairman, president, and CEO of Hologic. “The suspension of the medical device excise tax enabled us to make additional investments in research and development and accelerate availability of this critically important test.”
The Aptima Zika virus assay is a molecular diagnostic intended for the qualitative detection of RNA from Zika virus in human specimens. The assay has not been FDA cleared or approved, and is authorized for use only for the duration of the agency’s EUA for in vitro diagnostic tests for the detection or diagnosis of Zika virus infection.
For more information, visit Hologic.