Viatris Inc. and Atomo Diagnostics Announce Agreement with Unitaid to Expand Access to HIV Self-Test

Cost of the test will be reduced to improve access and stimulate demand in 135 low- and middle-income countries

PITTSBURGH and SYDNEY, April 29, 2021 /PRNewswire/ — Viatris Inc. and Atomo Diagnostics Limited (ASX:AT1) (Atomo) today announced a multi-year agreement with global health agency Unitaid to expand access to HIV self-testing in low- and middle-income countries (LMICs).

The agreement reached between Unitaid and Viatris (through its subsidiary Mylan), with support from Atomo, represents a significant market expansion of HIV self-testing, with commitments to make testing available in 135 eligible countries.

Designed and manufactured by Atomo, the Mylan HIV Self Test is distributed by Viatris in low- and middle-income countries. The test is prequalified by the World Health Organisation (WHO) and detects the presence or absence of HIV antibodies in a small blood sample obtained from a fingertip. Unlike standard, multi-component HIV test kits, the test developed by Atomo is an integrated, handheld device that reduces common sources of user error and offers unmatched usability.

Rakesh Bamzai, President – India, Emerging Asia & Access Markets and Commercial Expansion and Biosimilars -Emerging Markets, Viatris, commented, “We’re proud to partner with Unitaid and Atomo to reduce the cost of HIV self-testing, increase access to an important diagnostic tool for those living with HIV in low- and middle-income countries and contribute to the United Nations Sustainable Development Goal (SDG) to educate 90% of people of their HIV status. We have been on the frontlines of the global fight against HIV/AIDS for more than a decade and understand the importance of both prevention and treatment. This agreement highlights the impact of Viatris’ Global Healthcare Gateway, which opens up our global infrastructure to partners so that we can collectively make a difference by broadening healthcare access.”

Atomo’s co-founder and Managing Director, John Kelly, said, “This tremendously exciting announcement from Unitaid signifies a material step-up in demand for HIV self-tests globally.  This demand enables Atomo to achieve sustainable operational and supply chain efficiencies, allowing us to support Viatris in its discussions with Unitaid. We are delighted that the parties have now reached an agreement that will significantly expand the rollout of HIV self-testing in LMICs in the coming years.”

Unitaid’s announcement on the access expansion programme states that it will support the supply of up to one million HIV self-tests to LMICs to further stimulate in-country demand for self-testing, with Viatris/Atomo having been selected as one of the providers for this program.

The World Health Organisation (WHO) has estimated the global health HIV self-testing market to be 11 million tests in 2021, rising to 29 million tests by 20251.

In anticipation of sustained growth in the HIV self-testing global tender market, Atomo commissioned and qualified a new wholly owned HIV facility in South Africa that was certified in late 2020 by international regulators, including WHO. This facility is now fully operational and ready to support HIV production for tender contracts in LMICs, as well as Atomo’s existing HIV business in Australia and Europe.

Mr Kelly added, “This agreement is not just a significant and important moment in the growth of Atomo, it’s also further confirmation of the versatility and performance of our unique all-in-one diagnostic test platforms and drives lower costs across the business. Not only have they proven themselves to be ideal for novel test applications like COVID-19 and anti-microbial resistance, but they are also suitable for deployment as part of mass-screening programs in decentralised settings. We are proud to have a role in driving equitable access to testing for HIV.”

About Viatris

Viatris Inc. (NASDAQ: VTRS) is a new kind of healthcare company, empowering people worldwide to live healthier at every stage of life. We provide access to medicines, advance sustainable operations, develop innovative solutions and leverage our collective expertise to connect more people to more products and services through our one-of-a-kind Global Healthcare Gateway®. Formed in November 2020, Viatris brings together scientific, manufacturing and distribution expertise with proven regulatory, medical and commercial capabilities to deliver high-quality medicines to patients in more than 165 countries and territories. Viatris’ portfolio comprises more than 1,400 approved molecules across a wide range of therapeutic areas, spanning both non-communicable and infectious diseases, including globally recognized brands, complex generic and branded medicines, a growing portfolio of biosimilars and a variety of over-the-counter consumer products. With a global workforce of approximately 45,000, Viatris is headquartered in the U.S., with global centers in Pittsburgh, Shanghai and Hyderabad, India. Learn more at and, and connect with us on Twitter at @ViatrisIncLinkedIn and YouTube.

About Atomo Diagnostics

Atomo Diagnostics (ASX:AT1) is a world leader in the development of user friendly rapid diagnostic test products that simplify testing in decentralized settings. Headquartered in Sydney, Australia, the company specializes in creating integrated rapid diagnostic test (RDT) platforms and finished products for blood-based point-of-care testing (POCT). The recipient of multiple international awards for innovation, Atomo’s unique all-in-one AtomoRapid™ handheld devices make it easy to test and screen for a range of infectious diseases and chronic conditions. Its patented products simplify testing procedures, reduce errors and enhance usability for professional users and untrained self-testers.

As well as commercializing rapid test products in its own brand, Atomo provides OEM solutions to specialist diagnostic and pharmaceutical companies worldwide. The company manufactures the first and only HIV self-test to have been approved to be used in Australia.

See more at

1   Johnson C et al (2020). HIV self-testing market forecasting. World Health Organization – Diagnostic Manufacturer Meeting. Power Point presentation (virtual meeting). 20th October 2020.October 2020.

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