Log in or Register for enhanced features | Forgotten Password?
White Papers | Suppliers | Events | Report Store | Companies | Dining Club | Videos
Diagnostics
In Vitro Diagnostics
Return to: MDBR Home | Diagnostics | In Vitro Diagnostics

Hologic receives PMA approval from FDA for HIV-1 viral load monitoring assay

Published 04 January 2017

Hologic has received premarket approval (PMA) from the US Food and Drug Administration (FDA) for its HIV-1 viral load monitoring assay.

The Aptima HIV-1 Quant assay is a test which amplifies nucleic acid for quantitative identification of RNA from HIV in plasma specimens.

It runs on Hologic’s Panther system, an integrated platform which automates all aspects of testing from sample to result.

With this system, hands-on time for laboratories is claimed to be reduced significantly, through random and continuous access with rapid turnaround time.

The assay uses a dual target approach against highly conserved regions in the HIV genome. It will deliver reliable and consistent quantification across HIV-1 groups and subtypes.

With Aptima’s availability on Panther system, every step from sample to result, can be completed within a single integrated instrument. This level of automation and performance can help laboratories to become more efficient while meeting the demands of HIV treatment monitoring.

Hologic also claims that Aptima’s performance has been tested with other HIV viral load monitoring assays in the market. It has been found that Aptima provides reliable results for consistent quantitation.

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 maximize use of the widely adopted, reliable and user-friendly Panther system."

West said: "Hologic has an impressive legacy in the virology space, which started two decades ago and spans the development of nucleic acid tests to screen the blood supply for HIV and HCV, to the launch of qualitative assays for HIV and HCV in the early 2000's.

"We leveraged this expertise and applied it to the development of the viral load portfolio on the Panther system."

The Aptima HIV-1 Quant assay is not approved for HIV-1 diagnosis in the US. Outside the US, the assay is CE-IVD marked for both diagnostic and monitoring claims, as is the Aptima HCV (hepatitis C) Quant Dx assay; the Aptima HBV Quant assay is CE-marked for hepatitis B monitoring.

The Aptima hepatitis C and B assays are not currently approved for sale in the US.