FDA OK's new claim for Hologic's HIV assay

By LabPulse.com staff writers

November 20, 2020 -- The U.S. Food and Drug Administration (FDA) has approved Hologic's diagnostic claim for its HIV-1 viral load monitoring assay, the Aptima HIV-1 Quant Dx assay.

The Aptima HIV-1 Quant Dx is now the first dual-claim assay for both diagnosis and viral load monitoring in the U.S., Hologic said. First approved in late 2016 for viral load monitoring, the assay is a molecular diagnostic test that runs on the automated, sample-to-result Panther system. It uses a dual target approach against highly conserved regions in the HIV genome designed to deliver results across HIV-1 groups and subtypes, Hologic said.

Hologic wins CE Mark for cervical cancer screening system
Hologic has secured the CE Mark for its Genius Digital Diagnostics digital cytology platform for cervical cancer screening. The system combines a new...
Hologic gets CE Mark for breast specimen x-ray system
Hologic has received the CE Mark for its Faxitron Path+ specimen radiography system, which can be used for breast tissue imaging. The system consists...
Hologic Q4 sales boom on diagnostics revenues
Booming revenues in its Molecular Diagnostics segment due to the COVID-19 pandemic helped Hologic post a 55.6% increase in sales for its fourth quarter....
Hologic scores $119M COVID-19 testing contract
The U.S. government has awarded a $119 million contract to Hologic to expand its production capacity for COVID-19 molecular tests.
Hologic debuts pooling protocol for COVID-19 tests
Hologic has validated the use of its Aptima and Panther Fusion molecular diagnostic COVID-19 assays with pooled patient samples and has also applied for...

Copyright © 2020 LabPulse.com

Last Updated ls 11/20/2020 4:32:56 PM

Register below for our weekly Letter from the Editor to receive the latest Clinical Lab news and insights.