Hologic's Panther Fusion® Bordetella Assay Now CE Marked in Europe

October 11, 2018

MARLBOROUGH, Mass. October 11, 2018 – Hologic, Inc. (Nasdaq: HOLX) announced today 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.[1] 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.

About Hologic, Inc.

Hologic, Inc. is an innovative medical technology company primarily focused on improving women’s health and well-being through early detection and treatment.  For more information on Hologic, visit www.hologic.com.

About Pertussis

An estimated 16 million cases and 195,000 deaths from pertussis occur globally each year.[2] In the EU, approximately 40,000 cases are reported each year.[3] Accurate detection of pertussis is important to guide antibiotic therapy for patients.[4]  Whooping cough is mostly associated with B. pertussis infection, but B. parapertussis is also responsible for a whooping cough-like disease. The latter generally has a milder clinical presentation, but is not easily distinguished from B. pertussis infection by symptoms.[5] Because B. parapertussis is often not confirmed with a laboratory diagnosis, the epidemiology of illness caused by B. parapertussis is poorly recognized.5

Forward-Looking Statements

This news release may contain forward-looking information that involves risks and uncertainties, including statements about the use of Hologic’s diagnostic products. There can be no assurance these products will achieve the benefits described herein or that such benefits will be replicated in any particular manner with respect to an individual patient, as the actual effect of the use of the products can only be determined on a case-by-case basis. In addition, there can be no assurance that these products will be commercially successful or achieve any expected level of sales. Hologic expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any such statements presented herein to reflect any change in expectations or any change in events, conditions or circumstances on which any such data or statements are based.

This information is not intended as a product solicitation or promotion where such activities are prohibited. For specific information on what products are available for sale in a particular country, please contact a local Hologic sales representative or write to womenshealth@hologic.com.

Hologic, Panther, Panther Fusion, Aptima and The Science of Sure are trademarks and/or registered trademarks of Hologic, Inc. in the United States and/or other countries.

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[1] Panther Fusion Bordetella assay [package insert]. AW-18637-001 Rev.001. San Diego, CA: Hologic, Inc.; 2018.

[2] Kilgore PE, et al. Pertussis: Microbiology, Disease, Treatment, and Prevention. Clin Microbiol Rev. 2016;29(3):449-486. doi:10.1128/CMR.00083-15.

[3] European Centre for Disease Prevention and Control. Disease Data from ECDC Surveillance Atlas for pertussis. https://ecdc.europa.eu/en/pertussis/surveillance-and-disease-data/atlas. Data released 2015. Accessed June 4, 2018.

[4] van der Zeer JFP, et al. Laboratory Diagnosis of Pertussis. Clin Microbiol Rev. 2015;28(4):1005-1026.

[5] Mastrantonio P, et al. Bordetella parapertussis Infection in Children: Epidemiology, Clinical Symptoms, and Molecular Characteristics of Isolates. J Clin Microbiol. 1998;36(4):999-1002.