-- Aptima® HBV Quant Assay Joins Tests for HIV-1 and HCV on the
Fully Automated Panther Instrument --
MARLBOROUGH, Massachusetts,
Dec. 10, 2015 /PRNewswire/
-- 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.
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, 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.
Forward-Looking Statements
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.
Contact:
Michael Watts
VP, Investor Relations and Corporate Communications
(858) 410-8588