MARLBOROUGH, Mass.,
Jan. 3, 2017 /PRNewswire/ -- Hologic,
Inc. (Nasdaq: HOLX) announced today that the U.S. Food and Drug
Administration (FDA) has granted PMA approval for the Company's
HIV-1 viral load monitoring assay. The Aptima® HIV-1
Quant assay is a nucleic acid amplification test for the
quantitative detection of RNA from HIV in plasma specimens.
The Aptima HIV-1 Quant assay runs on Hologic's
Panther® system, a market-leading, integrated platform
that fully automates all aspects of testing, from sample to result.
The system substantially reduces hands-on time for laboratories by
providing random and continuous access with rapid turnaround
time.
"Clinical laboratories have an increasing need to consolidate
testing onto automated instruments," said Tom West, president, Diagnostic Solutions
Division at Hologic. "Adding HIV viral load monitoring to our
existing women's health menu allows customers to maximize use of
the widely adopted, reliable and user-friendly Panther
system."
A number of published studies have compared the performance of
the Aptima HIV-1 Quant assay with other HIV viral load monitoring
assays currently on the market. The results of these studies
demonstrate that the Aptima HIV-1 Quant assay provides repeatable,
reliable results for consistent quantitation.1-4 This
consistency is critical for patient management, as it ensures that
detected changes in viral load are due to potential clinical
changes rather than assay variation.
The Hologic Aptima HIV-1 Quant assay
uses a dual target approach against highly conserved regions in the
HIV genome and is designed to deliver reliable, consistent
quantitation across HIV-1 groups and subtypes. Availability of the
assay on the Panther system enables every step, from sample to
result, to be completed within a single integrated instrument.
This combination of performance and automation will provide
labs the ability to become even more efficient while meeting
today's demands for HIV treatment
monitoring.
"Hologic has an impressive legacy in the virology space, which
started two decades ago and spans the development of nucleic acid
tests to screen the blood supply for HIV and HCV, to the launch of
qualitative assays for HIV and HCV in the early 2000's," said West.
"We leveraged this expertise and applied it to the development of
the viral load portfolio on the Panther system."
The Aptima HIV-1 Quant assay is not approved for HIV-1 diagnosis
in the United States. Outside the
U.S., the Aptima HIV-1 Quant Dx assay is CE-IVD marked for both
diagnostic and monitoring claims, as is the Aptima HCV (hepatitis
C) Quant Dx assay; the Aptima HBV Quant assay is CE-marked for
hepatitis B monitoring. The Aptima hepatitis C and B assays are not
currently approved for sale in the United
States. To learn more about the U.S. Aptima HIV-1 Quant
assay, please visit http://usaptimavirology.com.
The Aptima Quant viral load assays are not part of the recently
announced pending sale of Hologic's blood donor screening business
to Grifols, and the Aptima Quant viral load assays will continue to
be owned by Hologic upon closing of the transaction with
Grifols.
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 Forward-Looking Statements
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 registered
trademarks of Hologic, Inc. in the United
States and/or other countries.
1Hopkins, et.al. Comparative performance of the new
Aptima HIV-1 Quant Dx assay with three commercial PCR-based HIV-1
RNA quantification assays. Journal of Clinical Virology, 69 (2015)
56-62.
2Nair, SV, et al. Aptima HIV-1 Quant Dx – A fully
automated assay for both diagnosis and quantification of HIV-1.
Journal of Clinical Virology, 77 (2016) 46-54.
3Sahoo, et.al. Evaluation of the Aptima HIV-1 Quant Dx
assay using plasma and dried blood spots. Journal of Clinical
Microbiology, 54 (2016) 2597-2601.
4Sam, et.al. Evaluation of performance characteristics
of the Aptima HIV-1 Quant Dx assay for detection and quantitation
of Human Immunodeficiency Virus Type 1 in plasma and cervicovaginal
lavage samples. Journal of Clinical Microbiology, 54 (2016)
1036-1041.
Hologic Investor Contact
Michael Watts
Vice President, Investor Relations and Corporate Communications
+1 (858) 410-8588
michael.watts@hologic.com
Hologic Media Contact
Jane
Mazur
Senior Director, Divisional Communications
+1 (585) 355-5978
jane.mazur@hologic.com
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SOURCE Hologic, Inc.