Roche said today it has received the FDA’s Emergency Use Authorization (EUA) for its LightMix® Zika rRT-PCR Test, enabling the company to bypass the agency’s regular approval process.
LightMix is an assay for the qualitative detection of Zika viral RNA in combination with a full-process RNA control that monitors steps from extraction to PCR result. The test is designed to detect the virus in EDTA plasma or serum samples using the company’s LightCycler® 480 Instrument II or cobas z 480 Analyzer.
According to Roche, nucleic acid extraction is authorized to be performed with the company’s MagNA Pure Compact Instrument (and Isolation Kit I–Large Volume)—or the MagNA Pure 96 Instrument (and DNA and Viral NA Large Volume Kit) for high-throughput automated extraction, for laboratories wanting to process a higher number of samples.
The end-to-end automated process—from sample preparation to results for up to 96 samples—can be performed in 2.5 hours, Roche said.
“As a leader in diagnostics, Roche is committed to providing testing solutions for the world's most challenging healthcare emergencies. The FDA's granting of this EUA supports our commitment to help healthcare professionals who are working to combat this serious disease,” Uwe Oberlaender, head of Roche Molecular Diagnostics, said in a statement.
In addition to the LightMix® Zika rRT-PCR Test, Roche has also developed the cobas® Zika Test for use with the cobas® 6800/8800 Systems. That test is currently being used in blood centers in the U.S., under an IND protocol to initiate collection and testing of blood samples for screening.
LightMix has not technically been cleared or approved by the FDA—which is allowed through EUA to facilitate the availability and use of medical countermeasures during public health emergencies.
According to the FDA’s website, LightMix is the 10th in vitro diagnostic test for Zika approved by the agency since its parent agency, the U.S. Department of Health and Human Services, on February 26 declared Zika to pose “a significant potential for a public health emergency that has a significant potential to affect national security or the health and security of United States citizens living abroad.”