FDA Grants Premarket Approval for HIV Monitoring Test

The Aptima HIV-1 Quant assay will significantly cut lab times.

The FDA granted premarket approval (PMA) to Hologic Inc’s Aptima HIV-1 Quant assay, which measures HIV viral loads.

The Aptima HIV-1 Quant assay is a nucleic acid amplification test for the quantitative detection of RNA from HIV in plasma specimens, according to NASDAQ.

The test runs on the company’s integrated platform, called the Panther system, which fully automates all aspects of testing from sample to result. This system provides random and continuous access with a quick turnaround time, significantly reducing the amount of time spent in laboratories.

A dual target approach against highly-conserved regions in the HIV genome allows Aptima HIV-1 Quant assay to deliver consistent and accurate quantitation across HIV-1 groups and subtypes, NASDAQ reported.

The instrument will allow labs to improve efficacy and help in the treatment of HIV.