Aptima HIV-1 Quant Dx Assay Receives Additional FDA Approval for Use as an Aid in the Diagnosis of HIV Infection
-- First FDA-Approved Assay for Both Qualitative Diagnosis and
Quantitative Viral Load Monitoring --
Hologic, Inc. (Nasdaq: HOLX) announced today that the U.S. Food
and Drug Administration (FDA) has approved a diagnostic claim for
its HIV-1 (human immunodeficiency virus type 1) viral load
monitoring assay. The Aptima® HIV-1 Quant Dx assay is now the first
dual-claim assay for both diagnosis and viral load monitoring in
the United States.
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Aptima® HIV-1 Quant Dx assay (Photo:
The Aptima HIV-1 Quant Dx assay, which was approved in late 2016
for viral load monitoring, is a molecular diagnostic test that runs
on the fully automated, sample-to-result Panther® system.
The assay utilizes a dual target approach against highly conserved
regions in the HIV genome that is designed to deliver reliable,
consistent qualitative and quantitative results across HIV-1 groups
and subtypes. The Aptima HIV-1 Quant Dx assay is also CE IVD-marked
for both diagnostic and viral load monitoring claims.
“This is an exciting new claim for our highly sensitive and
reliable HIV test because it has the potential to improve patient
care,” said Kevin Thornal, president of Diagnostic Solutions at
Hologic. “A simultaneous viral load measurement with diagnosis will
allow healthcare providers to guide treatment choices for patients
to begin therapy immediately. The dual claim will also benefit our
clinical laboratory customers, who continuously seek to consolidate
their testing as much as possible onto one automated platform.”
Starting treatment at the time of diagnosis is expected to
reduce the risk of HIV transmission to others and to maximize
prospects for long-term good health.
There are approximately 1.2 million people living in the US with
HIV, with 38,000 new infections in 2018.1
For more information about Hologic’s U.S. virology portfolio,
please visit: http://usaptimavirology.com.
About the Panther and Panther Fusion
The Panther molecular diagnostics system is a best-in-class,
fully automated, sample-to-result platform that can be used in
low-, medium- or high-throughput laboratories. With a small
footprint, adaptable workflow options and consolidated testing
menu, it combines women’s health, sexually transmitted infection
and viral load testing, which can all be done simultaneously. The
Panther Fusion system provides an expanded in vitro diagnostics
menu, as well as Open AccessTM functionality to run laboratory
developed tests. Hologic’s Panther and Panther Fusion systems now
offer 18 FDA-cleared assays and 20 CE-marked assays that detect
more than 20 pathogens. More than 2,250 Panther systems have been
installed in clinical diagnostic laboratories around the world.
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.
This press 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. 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 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
statements are based.
Hologic, The Science of Sure, Aptima and Panther are trademarks
and/or registered trademarks of Hologic, Inc. in the United States
and/or other countries.
- HIV.gov: U.S. Statistics.
Accessed on 11/12/2020.
SOURCE: Hologic, Inc.
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