-- The new assay is certified for both diagnosis and viral
load monitoring on the Panther system
BEDFORD, Massachusetts,
Dec. 1, 2014 /PRNewswire/ -- Hologic,
Inc. (NASDAQ: HOLX), today announced CE mark certification for its
new Aptima HIV-1 Quant Dx assay for use on the Company's Panther
system. The Aptima HIV-1 Quant Dx assay, employing Hologic
proprietary real-time transcription-mediated amplification
(Real-time TMA) technology, is the first HIV viral load assay with
a dual claim for both diagnosis and treatment monitoring. This
milestone marks Hologic's entry into the viral load market.
"The Aptima HIV-1 Quant Dx assay combines exceptional
performance with the Panther system's full automation, and extends
our commitment to give customers more freedom and control over
workflow in viral load testing," said Tom
West, Division President, Diagnostic Solutions. "The
availability of this new assay on the Panther system eases the
burden of laborious manual sample preparation, frees laboratories
from batching restrictions required by older systems, and helps
low- to high-volume laboratories streamline workflow. The Aptima
HIV-1 Quant Dx assay sets a new benchmark for manufacturers of
viral load assays and is the first in a line of viral load
offerings that the Company expects to introduce including assays
for Hepatitis C and Hepatitis B."
The Hologic Aptima HIV-1 Quant Dx assay is designed to meet
today's demands for HIV diagnosis and treatment monitoring. The new
assay uses a dual target approach against highly conserved regions
in the HIV genome, a sophisticated primer design, and redundancy of
oligonucleotides for protection against mutations, thereby helping
to ensure accurate detection and quantitation of HIV-1. The assay
is designed to deliver both sensitivity and precision across a
broad set of HIV-1 groups and subtypes; laboratories can now have
confidence in assay performance, despite drug selection pressures
and growing genetic diversity.
The Aptima HIV-1 Quant Dx assay is not currently approved for
use in the U.S.
For more information about Hologic's molecular diagnostic
products, please visit www.hologic.com.
About Hologic, Inc.:
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, The Science of Sure, TMA 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 News Release may contain forward-looking information that
involves risks and uncertainties, including statements about the
use of the Hologic Aptima HIV-1 Quant Dx assay and Panther system.
There can be no assurance these products 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 products 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 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.
Contacts:
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Marianne
McMorrow
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Jim Culley
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Manager, Corporate
Communications
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Senior Director,
Corporate Communications
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+1-781-999-7723
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+1-302-528-1312
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marianne.mcmorrow@hologic.com
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jim.culley@hologic.com
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