Marlborough, Mass., December 10, 2015 – Hologic, Inc. (Nasdaq: HOLX) has earned CE-IVD certification for its Aptima HBV Quant assay on the fully automated Panther® instrument, the Company announced today.
This assay expands the European virology menu available on the Panther system, which previously included the Aptima HIV-1 Quant Dx and Aptima HCV (hepatitis C virus) Quant Dx viral load assays.
“We are excited to now offer European customers three important viral load assays on our Panther system,” said Claus Egstrand, Hologic’s Group President, International. “Laboratories can now quantify HIV-1, HCV and HBV accurately while benefiting from random access and more walkaway freedom.”
The newest addition to the Panther system’s viral load menu quantitates HBV DNA across all major genotypes A-H. The assay offers the only dual-target approach that delivers accurate quantitation over a broad linear range and tolerates potential mutations in the HBV genome. The Aptima HBV Quant assay’s linear range is one of the broadest on the market (from 10 IU/mL to 1 billion IU/mL). This helps ensure precise quantitation even for samples with the high viremia often associated with chronic HBV infection.
With the Panther system, laboratorians can now run viral load assays for HIV-1, HCV and HBV in parallel, or even from a single patient sample. This combination provides not only sensitive and precise amplification, but also sample-to-result automation. The Panther system’s growing assay menu also includes tests for chlamydia, gonorrhea, trichomoniasis, HPV and HPV genotyping.
The Aptima HBV Quant assay, Aptima HCV Quant Dx assay, and Aptima HIV-1 Quant Dx assay are not approved for use in the United States.
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, Science of Sure, Aptima, Panther, and associated logos are trademarks and/or registered trademarks of Hologic, Inc. and/or its subsidiaries in the United States and/or other countries.
This news release may contain forward-looking information that involves risks and uncertainties, including statements about the use of Hologic’s Aptima HBV Quant assay and the Panther system. There can be no assurance that 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. The actual effect of the use of the products can only be determined on a case-by-case basis depending on the particular circumstances and patient in question. In addition, there can be no guarantee that these products will be adopted by customers 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 statements are based.
VP, Investor Relations and Corporate Communications