NEW YORK (GenomeWeb News) – Hologic said after the close of the market on Tuesday that the US Food and Drug Administration has approved its Aptima HPV assay for use on the fully automated Panther system.
The Aptima HPV test is performed with Hologic's ThinPrep liquid cytology specimen and can be tested before and after processing for cytology testing on the ThinPrep 2000 system, the Bedford, Mass.-based company said.
The messenger RNA-based assay is a nucleic acid amplification test. It detects 14 high risk strains of human papillomavirus that are associated with cervical cancer and precancerous lesions. It detects mRNA overexpressed from the E6 and E7 viral oncogenes.
Hologic said the test has demonstrated "significantly improved" specificity without compromised sensitivity," and added that it "extends the capability of low- to high-volume laboratories to run multiple tests from a single specimen, on a cost effective, highly flexible, and fully automated molecular testing platform."
In a statement, Rohan Hastie, SVP and GM of Diagnostics for Hologic, said "Our Panther system is a world-class automation solution for a broad range of molecular diagnostic laboratories. Expanding the menu of available assays on Panther builds on our platform-centric strategy of delivering workflow efficiencies and revenue generating opportunities to our laboratory partners."