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Hologic HIV-1 Quant Test Wins FDA Clearance

NEW YORK (GenomeWeb) – A quantitative nucleic acid amplification test for HIV-1 from Hologic has been granted pre-market approval from the US Food and Drug Administration, the company announced today.

The Aptima HIV-1 Quant test runs on Hologic's fully automated Panther system and amplifies RNA from patient plasma specimens for the purposes of HIV viral load monitoring in the US. Outside the US, it is CE-IVD marked for both diagnosis and monitoring.

The test has recently been the subject of published studies evaluating its use on clinical samples, comparing it to three other commercial assays, and determining its performance characteristics in plasma and cervicolavage samples as well as in dried blood spots.

Hologic also makes CE-marked viral load monitoring assays for hepatitis B and hepatitis C viruses for which it is seeking FDA approval. The company noted in a statement that its viral load assays are not part of the pending sale of the firm's blood screening business to Grifols.