Hologic’s Aptima HIV-1 Quant assay gets PMA approval from FDA


US-based medical device company Hologic has secured premarket approval (PMA) from the US Food and Drug Administration (FDA) for its HIV-1 viral load monitoring assay, Aptima HIV-1 Quant assay.

Based on Hologic’s Panther system, the HIV-1 Quant assay has been developed as a nucleic acid amplification test to quantitatively detect RNA from HIV in plasma specimens.

Panther system is an integrated platform which enables automatic running of all the aspects of testing which minimises hands-on time for laboratories with rapid turnaround time.

"Adding HIV viral load monitoring to our existing women's health menu allows customers to maximise use of the widely adopted, reliable and user-friendly Panther system."

Hologic diagnostic solutions division president Tom West said: "Clinical laboratories have an increasing need to consolidate testing onto automated instruments.

"Adding HIV viral load monitoring to our existing women's health menu allows customers to maximise use of the widely adopted, reliable and user-friendly Panther system."

The Hologic Aptima HIV-1 Quant assay uses a dual target approach to detect HIV-1 RNA in highly conserved regions in the HIV genome and delivers reliable, consistent quantitation across HIV-1 groups and subtypes.

It features a sophisticated primer design along with redundancy of oligonucleotides to protect against mutations.

The Aptima HIV-1 Quant assay takes lesser time than HIV p24 tests and Anti-HIV 1/2 immunoassays to detect HIV-1 RNA in plasma and serum.

It can also assist in monitoring the effect of antiretroviral treatment by analysing changes in the concentration of HIV-1 RNA in plasma.

The Aptima HIV-1 Quant assay is not suited to be used to screen blood or plasma donors.