HERTFORDSHIRE, England
and PITTSBURGH and SYDNEY,
July 8, 2019 /PRNewswire/
-- Global pharmaceutical company Mylan N.V. (NASDAQ:
MYL) and medical device manufacturer Atomo Diagnostics today
announced that the Mylan HIV Self Test, a handheld in
vitro HIV rapid diagnostic test for self-testing,
has received Prequalification approval by the World Health
Organization (WHO PQ).
The WHO PQ process includes a rigorous evaluation of the test's
technical performance and manufacturing sites. Prequalification
signifies that the product meets global standards of quality,
safety and performance and is a signal to global funders and
Ministries of Health that the product can be procured. The Mylan
HIV Self Test detects the presence or absence of HIV antibodies
through a fingerstick. It uses one-fifth the volume of blood
necessary for other tests and provides a result in just 15
minutes.
Linda-Gail Bekker, Executive
Director of the Desmond Tutu HIV Foundation and a former president
of the International AIDS Society, stated, "HIV self-testing can be
a game-changer in helping us meet the ambitious UNAIDS 90-90-90
targets, which require that 90% of all HIV positive people know
their status by 2020. Having more high-quality and user-friendly
HIV self-tests on the market, like the Mylan HIV Self Test
that has been Prequalified by the World Health Organization, will
give us a powerful tool in expanding diagnosis and treatment of
vulnerable and previously untested populations."
The convenience and discretion afforded by self-testing enables
individuals to test in the comfort and privacy of their own home,
making the test an effective way of reaching hard-to-reach
populations. In September 2018, Mylan
announced a partnership with Atomo Diagnostics, the manufacturer of
the test, covering more than 100 countries across Africa, Asia,
the Middle East, the Commonwealth
of Independent States (CIS), and Latin
America.
About WHO Prequalification (PQ)
WHO Prequalification
(PQ) aims to ensure that diagnostics, medicines, vaccines, and
immunization-related equipment and devices for high burden diseases
meet global standards of quality, safety and efficacy, to optimize
use of health resources and improve health outcomes.
The prequalification process consists of a transparent,
scientifically sound assessment, which includes dossier review,
consistency testing or performance evaluation, and site visits to
manufacturers. This information, in conjunction with other
procurement criteria, is used by UN and other procurement agencies,
including PEPFAR and Global Fund, to make purchasing decisions
regarding diagnostics, medicines and/or vaccines.
For more information,
visit https://www.who.int/topics/prequalification/en/.
About Mylan
Mylan is a global pharmaceutical company committed to setting
new standards in healthcare. Working together around the world to
provide 7 billion people access to high quality medicine, we
innovate to satisfy unmet needs; make reliability and service
excellence a habit; do what's right, not what's easy; and impact
the future through passionate global leadership. We offer a growing
portfolio of more than 7,500 marketed products around the world,
including antiretroviral therapies on which more than 40% of people
being treated for HIV/AIDS globally depend. We market our products
in more than 165 countries and territories. We are one of the
world's largest producers of active pharmaceutical ingredients.
Every member of our approximately 35,000-strong workforce is
dedicated to creating better health for a better world, one person
at a time. Learn more at Mylan.com. We routinely post
information that may be important to investors on our website
at investor.mylan.com.
About Atomo Diagnostics
Atomo Diagnostics is a
world leader in medical device design and development, based in
Sydney, Australia. The
company specialises in creating integrated rapid diagnostic test
(RDT) platforms for blood-based testing. The recipient of
multiple international awards for innovation, Atomo's
all-in-one AtomoRapid™ handheld devices make it
easy to test and screen for a range of infectious diseases and
chronic conditions. Unlike standard, multi-component rapid
test kits, AtomoRapid™ platforms integrate features and
functionality, including built-in sterile safety lancets,
calibrated blood collection systems, and unique buffer delivery
mechanisms.
As well as commercialising products in its own brand, Atomo
provides OEM product development services to specialist diagnostic
companies worldwide.
To find out more, visit: http://atomodiagnostics.com/
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SOURCE Mylan N.V.