Hologic, Inc. have announced that its Panther Fusion^® Bordetella assay has received CE mark in Europe. This assay, the latest in a growing menu of Panther Fusion® and Aptima® assays, brings full automation, efficiency and excellent assay performance to Bordetella detection. The Panther Fusion system retains all the key benefits of the Panther platform, including full sample-to-result automation, and is suitable for any size laboratory.

The Panther Fusion^® Bordetella assay is a real-time PCR assay for the detection and differentiation of Bordetella pertussis (B. pertussis) and Bordetella parapertussis (B. parapertussis) from nasopharyngeal swab specimens collected from symptomatic patients. Bordetella pertussis is the bacteria associated with “Whooping cough,” one of the 52 notifiable communicable diseases in the European Union.

The launch of the Panther Fusion^® Bordetella assay expands the portfolio of respiratory assays available for Panther Fusion, enabling our European customers to deliver a better service to their clients and ultimately to patients,” said João Malagueira, Hologic’s VP Diagnostics, EMEA.  “The assay accurately detects and differentiates Bordetella pertussis and parapertussis, ensuring the physician can select the appropriate antibiotic treatment for their patient.”

The Panther Fusion^® Bordetella assay enables laboratory customers to leverage the benefits of the fully automated Panther Fusion system, which provides random and continuous access to improve laboratory efficiency. Laboratories can combine cervical and sexual health, virology, respiratory, hospital-acquired infections, and Open Access® tests on the Panther Fusion system, running up to 32 different assays at the same time.  The system offers labs the potential to process up to 500 Panther Fusion and Aptima assays in an 8-hour period.

Panther Fusion is available as a full system, or the Panther Fusion module can be attached to existing Panther systems in the field to extend testing capabilities. The Panther Fusion module adds the capacity to run PCR (polymerase chain reaction) assays in addition to tests based on TMA (transcription-mediated amplification), the proprietary Hologic chemistry that powers the Company's Aptima® brand.  Key system benefits include the ability to run multiple tests from a single sample, random and continuous access, sample processing with rapid turnaround time, continuous loading, and STAT capabilities. The Panther Fusion assays utilize ready to use, unit-dose lyophilized reagents, which have 60-day on-board stability to help reduce waste and the need for manual reagent preparation.

Diagenode, a leading diagnostics assay provider based in Liege, Belgium and New Jersey, USA, was a principal partner in developing the Panther Fusion Bordetella assay in collaboration with Hologic, and is the manufacturer of the kit.