Hologic’s Aptima HIV-1 Quant Dx Assay Receives Two CE Marks, Making It the First and Only Dual-Claim Assay for Both Viral Load and Early Infant Diagnosis

MARLBOROUGH, Mass.–(BUSINESS WIRE)–lt;a href=”https://twitter.com/hashtag/Aptima?src=hash” target=”_blank”gt;#Aptimalt;/agt;–Hologic, Inc. (Nasdaq: HOLX) announced today that its Aptima®
HIV-1 Quant Dx Assay has received two new CE marks in Europe – for early
infant diagnosis (EID) and for testing dried blood spots (DBS). This
means the assay can be used to qualitatively detect HIV-1 RNA as an aid
in the diagnosis of HIV-1 infected infants under 18 months old, and to
test an additional sample type (DBS) to monitor viral load and disease
progression in HIV-1 infected individuals in European and African
countries. It is the first and only dual-claim assay for both viral load
and early infant diagnosis. The dried blood spot claim is particularly
important in the African market as it is a much more stable and easily
transportable sample type than liquid blood.

The Aptima HIV-1 Quant Dx assay is an in vitro nucleic acid
amplification test (NAAT) for the detection and quantitation of HIV type
1 (HIV-1) on the fully automated Panther™ system. It is intended as an
aid in the diagnosis of HIV-1 infection, as a confirmation of HIV-1
infection, and as an aid in the clinical management of patients infected
with HIV-1. The Aptima HIV-1 Quant Dx assay may also be used in
conjunction with clinical presentation and other laboratory markers for
disease prognosis in HIV-1 infected individuals.

“With 25 million people infected with HIV in sub-Saharan Africa alone,
there continues to be an urgent need for accessible testing, which is
crucial for managing care and reducing the spread of this
life-threatening infection,” said João Malagueira, vice president,
Europe South and Indirect Markets. “These new product extensions, along
with the recent announcement of our Hologic Global Access Initiative,
underline Hologic’s commitment to providing accessible testing. They
will enable healthcare providers in resource-limited settings to scale
up their HIV testing programmes to meet the 95-95-95 goals set out by
the World Health Organization (WHO).”

The Aptima HIV-1 Quant Dx assay was awarded World Health Organization
prequalification for in vitro diagnostics using plasma samples on
December 21, 2017. This means that the assay meets WHO standards of
quality, safety, performance and reliability, and allows global health
organizations to consider the Aptima HIV-1 Quant Dx assay for public
sector procurement in resource-limited settings.

The Aptima HIV-1 Quant Dx assay is processed on Hologic’s Panther
system, a market-leading, integrated platform that fully automates
molecular testing with true sample-to-result automation, adaptable
workflow options, and a broad testing menu. The Panther system is
designed to be modular and scalable, accommodating the needs of large,
centralized labs as well as smaller, decentralized labs. The Panther
system offers the highest throughput per square meter of any comparable
molecular diagnostic instrument – up to 320 results in 8 hours in less
than one square meter of space.1,2

Hologic has a long-term legacy in the virology space that began two
decades ago and spans development of the first NAATs to screen the blood
supply for HIV and HCV (hepatitis C virus). In the early 2000s,
Hologic’s diagnostic portfolio evolved to include qualitative assays for
HIV and HCV, and now also includes quantitative assays for HIV, HBV
(hepatitis B virus) and HCV.

About Hologic

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.

Hologic Global Access Initiative

The Hologic Global Access Initiative will offer a single, all-inclusive
pricing structure with no upfront cost or capital expenditure, providing
access to four crucial molecular diagnostic tests across all eligible
countries. This offers resource-limited countries a new, less costly way
to mitigate the burden of infectious diseases with increased testing
supply and superior technology. For more information, see www.hologic.com/globalaccessinitiative.

UNAIDS’ 95-95-95 goal

UNAIDS’ 95-95-95 goal states that by 2030, 95 per cent of people living
with HIV will know their status, 95 per cent of people with diagnosed
HIV infection will receive sustained antiretroviral therapy, and 95 per
cent of people receiving antiretroviral therapy will have viral

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 [email protected].

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.

SOURCE: Hologic, Inc.


1 Hologic, Inc. Data on File.
2 Ratnam S, et
al. Workflow and maintenance characteristics of five automated
laboratory instruments for the diagnosis of sexually transmitted
infections. J Clin Microbiol. 2014;52(7); 2299-2304.
UNAIDS. Fast-Track – Ending the AIDS epidemic by 2030. 2014 http://www.unaids.org/en/resources/documents/2014/JC2686_WAD2014report


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[email protected]

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[email protected]


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