Hologic Announces FDA Approval of Aptima® CMV Quant Assay for Human Cytomegalovirus
May 10 2022 - 4:02PM
Business Wire
-- Hologic’s first quantitative test for
transplant pathogen monitoring standardizes clinical information to
help enhance patient outcomes --
Hologic, Inc. (Nasdaq: HOLX) announced today that the U.S. Food
and Drug Administration (FDA) approved its Aptima CMV Quant assay
to quantify the viral load of cytomegalovirus (CMV) in patients who
have had solid organ or stem cell transplants. The test is the
first to be introduced in the U.S. by Hologic for post-transplant
pathogen detection and monitoring on Hologic’s fully automated
Panther® system, and joins the existing portfolio of diagnostic and
viral load testing for HIV-1, Hepatitis C and Hepatitis B.
“We have a legacy of innovation in viral load testing, and our
Aptima CMV Quant assay is the first in a series of planned
quantitative assays to support patient care following transplant
surgery,” said Michelle Garsha, President, Diagnostic Solutions at
Hologic. “We’re committed to providing our laboratory partners with
superior solutions that improve workflow efficiency, support
provider and patient needs and address the challenges faced by
today’s molecular lab.”
CMV is a common virus that typically causes mild or asymptomatic
infections in people with healthy immune systems. However,
transplant recipients typically are artificially immunosuppressed
to prevent transplant rejection, which makes them more vulnerable
to infections. If left untreated, CMV infection can lead to severe
disease, transplant rejection and even death. Guidelines from the
American Society of Transplantation and the World Health
Organization recommend CMV monitoring as standard of care to help
guide treatment decisions for transplant patients, depending on
their risk and transplant organ type.1-2
“It is imperative to have highly accurate, reproducible results
to monitor viral load trends of CMV infections over time in plasma
of transplant patients,” says Karen Harrington, PhD, Head of
Scientific Affairs for Diagnostic Solutions at Hologic. “Our assay
aligns with the international quantitative standards, offering
laboratories and healthcare providers confidence in the results
each and every time, ultimately helping to enhance patient
management and outcomes.”
The Aptima CMV Quant assay also is CE-marked for diagnostic and
viral load monitoring use in Europe. Hologic intends to pursue
regulatory approvals for other transplant assays that are currently
in development, including BK Virus and Epstein-Barr Virus. Learn
more about Aptima virology assays.
About the Panther System
The Panther system for molecular diagnostics is a best-in-class
fully automated, sample-to-result platform with adaptable workflow
options and consolidated testing menu. The Panther Fusion® system
provides an expanded in-vitro diagnostics (IVD) menu, as well as
Open Access™ functionality to run laboratory-developed tests
(LDTs). Hologic’s Panther and Panther Fusion systems now offer 19
FDA-cleared, approved, and authorized assays and up to 21 assays
outside the U.S. depending on the region. This high-throughput
molecular diagnostic platform combines comprehensive sexual health,
cervical health, viral load, respiratory testing and open channel
functionality on a fully automated system.
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 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, Panther and Panther Fusion
are registered trademarks of Hologic, Inc. in the United States
and/or other countries.
SOURCE: Hologic, Inc.
_______________________________________
References:
1. Kotton, Camille N; Kumar, Deepali; Caliendo, Angela M;
Huprikar, Shirish; Chou, Sunwen; Danziger-Isakov, Lara; Humar, Atul
(2018). The Third International Consensus Guidelines on the
Management of Cytomegalovirus in Solid-organ Transplantation.
Transplantation, 102(6):900-931.
2. Razonable AA, Humar A. Cytomegalovirus in solid organ
transplant recipients-Guidelines of the American Society of
Transplantation Infectious Diseases Community of Practice. Clin
Transplant. (2019) 33(9)
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