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Hologic’s Aptima HPV Assay to be EBM-Reimbursed for Cervical Screening in Germany

The Aptima HPV assay accurately detects the types of human papillomavirus most likely to cause cervical cancer

Manchester, England, 1 April 2015 -- Hologic, Inc. today announced that its Aptima HPV assay will be reimbursable in Germany effective April 1, 2015 per EBM (Uniform Value Scale) code 30820. The assay is a nucleic acid amplification test that detects 14 high-risk strains of human papillomavirus (HPV) mRNA associated with cervical cancer and precancerous lesions from the E6/E7 oncogenes. HPV is one of the most common sexually transmitted infections and is recognized as the leading cause of most cervical cancers worldwide.

“Hologic’s Aptima HPV assay is a clinically proven diagnostic tool that helps healthcare providers more accurately assess a patient’s risk of developing cervical cancer while minimizing the risk of false-positive results that can cause unnecessary clinical management and create patient anxiety,” said Hilja Ibert, Hologic’s Vice President and General Manager, International Diagnostic Solutions.“The availability of reimbursement for our mRNA-based HPV assay should positively impact patient access to this advanced cervical cancer screening test. Our innovative assays and advanced automation platforms, like Panther, are designed to work together to help laboratories and clinicians quickly and accurately screen specimens with a goal of earlier detection and better patient outcomes.”

Professor Thomas Iftner, Head of the Section of Experimental Virology, University Hospital Tübingen, and Principal Investigator of the German Aptima Screening Trial (GAST), said, “In the GAST study, the Aptima HPV assay showed equivalent sensitivity and improved clinical specificity compared to a validated DNA test. The Aptima assay reduced the number of referrals to colposcopy more than 20%.” The GAST trial included 10,000 women aged 30 and older who visited their private OB/GYN for routine cervical cancer screening.

The Aptima HPV assay can be used with Hologic’s ThinPrep liquid cytology specimens, either before or after the sample has been processed for cytology testing on a ThinPrep slide processor. With this solution, Hologic enables co-testing and triage testing with cytology and HPV from one sample to be executed efficiently and in a high quality. Hologic’s ThinPrep Pap test is one of the most widely used methods for cervical screening.

Hologic’s automation platforms are designed to improve productivity, enhance chain-of-custody procedures and deliver reliable, reproducible results. The Company’s latest advance, the Panther system, is a scalable testing platform for virtually any size lab environment. A fully automated, sample-to-answer instrument, the Panther system eliminates the need for batch processing and automates all aspects of nucleic acid amplification testing on a single, integrated platform.

 

About Hologic

Hologic, Inc. is a leading developer, manufacturer and supplier of premium diagnostic products, medical imaging systems and surgical products. The Company’s core business units focus on diagnostics, breast health, GYN surgical, and skeletal health. With a unified suite of technologies and a robust research and development program, Hologic is dedicated to The Science of Sure. For more information on Hologic, visit www.hologic.com.

Hologic, Aptima, Panther, ThinPrep, The Science of Sure, and associated logos are trademarks and/or registered trademarks of Hologic, Inc. and/or its subsidiaries in the United States and/or other countries.

Forward-Looking Statement Disclaimer

This press release may contain forward-looking information that involves risks and uncertainties, including statements about the use of Hologic’s Aptima HPV assay, ThinPrep products and Panther system. There can be no assurance the assays, products and systems will achieve the benefits described herein and 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 assays, products and systems can only be determined on a case-by-case basis depending on the particular circumstances and patient in question. Hologic expressly disclaims any obligation or undertaking to release publicly any updates or revisions to the statements presented herein to reflect any change in the Company's expectations or any change in events, conditions or circumstances on which any such statements are based.

Contacts

Marianne McMorrow

Carol Smith

Manager, Corporate Communications

Marketing Communications Manager

marianne.mcmorrow@hologic.com

carol.smith@hologic.com

Tel: +1 781 781 999 7723

Tel:  +44 (0) 161 946 2220