Skip to main content
Premium Trial:

Request an Annual Quote

FDA Approves Hologic's Aptima Assay for Panther System

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."

The assay was CE marked in 2008 and received FDA approval on the Tigris system in 2011. Canada approved the assay in April.

The Scan

Genetic Tests Lead to Potential Prognostic Variants in Dutch Children With Dilated Cardiomyopathy

Researchers in Circulation: Genomic and Precision Medicine found that the presence of pathogenic or likely pathogenic variants was linked to increased risk of death and poorer outcomes in children with pediatric dilated cardiomyopathy.

Fragile X Syndrome Mutations Found With Comprehensive Testing Method

Researchers in Clinical Chemistry found fragile X syndrome expansions and other FMR1 mutations with ties to the intellectual disability condition using a long-range PCR and long-read sequencing approach.

Team Presents Strategy for Speedy Species Detection in Metagenomic Sequence Data

A computational approach presented in PLOS Computational Biology produced fewer false-positive species identifications in simulated and authentic metagenomic sequences.

Genetic Risk Factors for Hypertension Can Help Identify Those at Risk for Cardiovascular Disease

Genetically predicted high blood pressure risk is also associated with increased cardiovascular disease risk, a new JAMA Cardiology study says.