CE-IVD Certification of Aptima® HCV Quant Dx Assay on Panther®
System Continues Company's Expansion into Virology Testing
Market
MARLBOROUGH, Massachusetts,
Oct. 20, 2015 /PRNewswire/ -- Hologic
(NASDAQ: HOLX) has earned CE-IVD certification for its Aptima® HCV
(hepatitis C virus) Quant Dx assay on the fully automated Panther®
system, the Company announced today.
The Aptima HCV Quant Dx assay is CE-IVD certified for both
confirmation of active infection in patients with a positive HCV
antibody result, and for viral load monitoring. The assay
complements the previously certified Aptima HIV-1 Quant Dx assay,
as well as an expansive menu of women's health assays that run on
the Panther system in Europe.
"The Aptima HCV Quant Dx Assay on the Panther system brings
unprecedented agility and automation to HCV nucleic acid
amplification testing (NAAT)," said Claus Egstrand, Hologic's Group
President, International. "Laboratories that use the assay on
the Panther system can customize their workflow with random access
and more walkaway freedom compared to other viral load
platforms."
The Aptima HCV Quant Dx assay uses real-time
transcription-mediated amplification (TMA) to test plasma or serum
samples. The assay's robust design provides three levels of
protection against mutations, and offers excellent performance
across all major genotypes, with high sensitivity and precision
across a wide linear range. The assay's limit of detection
(LoD) is 4.3 IU/mL in plasma and 3.9 IU/mL in serum, and its lower
limit of quantitation (LLoQ) is 10 IU/mL.
Other assays that can be run on the Panther system in
Europe include the Aptima HIV-1
Quant Dx assay, as well as tests for chlamydia, gonorrhea,
trichomoniasis and human papillomavirus (HPV).
The Aptima HCV Quant Dx assay and the 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, Aptima, Panther, Science of Sure and associated logos
are trademarks and/or registered trademarks of Hologic, Inc. and/or
its subsidiaries in the United
States and/or other countries.
About 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 HCV Quant Dx assay, Aptima HIV-1 Quant Dx
assay, and the Panther system. 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 guarantee that these products will be
adopted by customers or achieve any expected level of sales.
Hologic expressly disclaims any obligation to release publicly any
updates or revisions to any such forward-looking statements to
reflect changes in expectations or in events, conditions or
circumstances on which any such statements are based.
Contact:
Michael Watts
VP, Investor Relations and Corporate Communications
(858) 410-8588