Mylan and Atomo Diagnostics Announce WHO Prequalification Approval for Mylan HIV Self Test
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.
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
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
For more information, visit https://www.who.int/topics/prequalification/en/.
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
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/
View original content to download multimedia:http://www.prnewswire.com/news-releases/mylan-and-atomo-diagnostics-announce-who-prequalification-approval-for-mylan-hiv-self-test-300880908.html
Mylan: Christine Waller (Media), 724.514.1968, Email: firstname.lastname@example.org, Melissa Trombetta (Investors), 724.514.1813, Email: InvestorRelations@mylan.com; Atomo Diagnostics, John Kelly, +61 (0)2 9099 4750, Email: email@example.com