Hologic Obtains European CE Mark for Use of Saliva Samples with COVID-19 Test
Hologic, Inc. (Nasdaq: HOLX) has obtained a CE Mark for the use
of saliva samples with the Aptima® SARS-CoV-2 assay in Europe. The
Aptima SARS-CoV-2 test is a molecular diagnostic assay that detects
the genetic material of the pathogen causing COVID-19. The test
runs on the fully automated Panther® system.
“This new CE Mark demonstrates our commitment to providing
European consumers and healthcare providers as many options as
possible to manage the ongoing pandemic,” said Jan Verstreken,
Hologic’s group president, International. “While vaccination is
helping stem the tide of COVID-19, we envision that testing will
continue to play an important role, particularly in screening
programs needed to reopen society.”
Collection of saliva is easy, noninvasive and painless. The
availability of this alternative specimen type should help
facilitate screening in schools, workplaces and other settings.
Certain European health authorities have determined that the
established assay performance with saliva and the ease of obtaining
the sample make saliva suitable for programs that use repeated
screenings. The Aptima SARS-CoV-2 assay is also CE-marked for use
with nasopharyngeal and nasal swabs as well as additional specimen
Hologic has expanded manufacturing capability to produce Aptima
tests in large quantities and has shipped more than 100 million
Aptima COVID-19 tests globally since the spring of 2020.
Approximately 2,600 Panther systems have been installed in clinical
diagnostic laboratories around the world.
For more information on the Aptima assays, visit
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, and Panther are registered
trademarks of Hologic, Inc. in the United States and/or other
SOURCE: Hologic, Inc.
version on businesswire.com: https://www.businesswire.com/news/home/20210713006093/en/
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