8/27/2020 Unitaid and CHAI announce agreement with Omega Diagnostics to increase access to new, instrument-free CD4 test

D4 test for people living with HI…

2020
April 28

Unitaid and CHAI announce agreement with Omega Diagnostics to

increase access to new, instrument-free CD4 test for people living
with HIV in over 130 low- and middle-income countries

Agreement is part of Unitaid and CHAI’s Advanced HIV Disease Initiative

To further increase access, CHAI and Unitaid are requesting partner

participation in an Early Market Access Vehicle to generate evidence and
inform implementation in additional countries

Unitaid and the Clinton Health Access Initiative, Inc. (CHAI) today announced an innovative
agreement with medical device manufacturer Omega Diagnostics that will help deliver
groundbreaking same-day CD4 testing technology for people living with HIV in over 130 low-
and middle-income countries at just US$3.98 per test— a significant percent reduction from
current costs and the lowest price for such a test in the world.

Especially in light of COVID-19, it is critical to rapidly and efficiently identify, prevent, and
treat advanced HIV disease and protect this population that is predisposed to vulnerabilities
of opportunistic infections. Every year 800,000 people die of largely preventable deaths from
HIV. In sub-Saharan Africa, more than a third of all people with HIV that begin antiretroviral
therapy (ART), and all children under five, have Advanced HIV Disease. Approximately 10
percent of these patients die within the first three months of starting ART. Despite these vast
numbers, the diagnostic tools, treatment, and preventative services required to address
Advanced HIV Disease are virtually non-existent in most low- and middle-income countries.

CD4 cell count testing at baseline, after treatment interruption, and during poor ART
response for all people living with HIV remains an important tool for classifying and
managing people with Advanced HIV Disease, as it helps identify those most at risk of
opportunistic infections such as tuberculosis (TB) and cryptococcal meningitis—the two

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8/27/2020 Unitaid and CHAI announce agreement with Omega Diagnostics to increase access to new, instrument-free CD4 test for people living with HI…

largest killers for those living with Advanced HIV Disease. Receiving CD4 results quickly helps
ensure that providers are able to rapidly make the best treatment decisions for their patients
to prevent opportunistic infections before they occur.

The agreement, part of the Unitaid-CHAI Advanced HIV Disease Initiative*, will address this
gap by significantly expanding access to the new VISITECT® CD4 Advanced Disease rapid
test, a disposable, instrument-free CD4 testing technology that can deliver same-day results
to accelerate diagnosis and treatment of deadly opportunistic infections in patients living with
Advanced HIV Disease.

The new agreement will help catalyze the market for same-day CD4 testing to ensure that
more countries have access to affordable, effective, and usable diagnostic technology, moving
the world closer to the goal of universal access to same-day CD4 testing. The pricing
agreement will benefit the public sectors of over 130 countries, which collectively account for
most of the global need for products to test and treat Advanced HIV Disease. It will also be
available to United Nations-related organizations, non-governmental/non-profit
organizations, development and/or public health financing mechanisms, or a procurement
agent appointed by any of these entities.

Unitaid has invested US$20 million in the Advanced HIV Disease Initiative to avert hundreds
of thousands of preventable AIDS-related deaths. The grant, which is implemented by CHAI,
seeks to increase access and affordability of new medicines and testing tools in low- and
middle-income countries.

The Omega VISITECT® CD4 Advanced Disease rapid test is a disposable, instrument-free,
point-of-care test that identifies people with Advanced HIV Disease. Developed by the Burnet
Institute in Melbourne, Australia, this test provides an affordable, convenient solution for use
at all levels of healthcare facilities, enabling the potential for those with Advanced HIV
Disease to rapidly access appropriate treatment before becoming seriously ill or dying.

The new VISITECT® Advanced Disease test can deliver CD4 results on the same day of
testing, helping health care providers make prompt treatment decisions to help patients and
identify and treat deadly opportunistic infections. Since the test is instrument-free and
disposable, it can enable any health worker at all levels of the health system to use the test at
the point-of-care, including those in hard-to-reach or rural areas where testing is currently
unavailable, and eliminates the need for maintenance.

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8/27/2020 Unitaid and CHAI announce agreement with Omega Diagnostics to increase access to new, instrument-free CD4 test for people living with HI…

Building on this pricing agreement, Unitaid has established an Early Market Access Vehicle
(EMAV), to be led by CHAI, to accelerate access to this groundbreaking product in a wide set
of countries to facilitate market introduction and establish evidence for the product’s use.

Through this project, the first of a two-phase strategy, Unitaid and CHAI plan to expand
country experience and a body of evidence on the use of the VISITECT® CD4 Advanced
Disease test from participating countries, which will serve to inform national implementation
and scale-up planning.

Beginning on April 28, 2020, CHAI and Unitaid will begin accepting Expressions of Interest
(EOI) and admitting selected partners to the EMAV on a rolling basis through September 30,
2021 (or when maximum volume commitment is delivered). Selected implementing partners
can qualify for Unitaid-funded procurement of VISITECT® CD4 Advanced Disease tests to
facilitate evidence generation and user experience to inform future national implementation
and planning and support routine use of the test. Partners can review the EOI here or
reach out to emav@clintonhealthaccess.org for more information.

A full list of eligible countries can be found below:

Appendix A: List of eligible countries

Low-Income Countries
Afghanistan Guinea-Bissau Sierra Leone
Benin Haiti Somalia
Burkina Faso Korea, Dem. People’s Rep. South Sudan
Burundi Liberia Syrian Arab Republic
Central African Republic Madagascar Tajikistan
Chad Malawi Tanzania
Congo, Dem. Rep Mali Togo
Eritrea Mozambique Uganda
Ethiopia Nepal Yemen, Rep.
Gambia, The Niger
Guinea Rwanda

Lower-Middle Income Countries

Angola India Papua New Guinea
Bangladesh Indonesia Philippines
Bhutan Kenya Sao Tome and Principe
Bolivia Kiribati Senegal

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8/27/2020 Unitaid and CHAI announce agreement with Omega Diagnostics to increase access to new, instrument-free CD4 test for people living with HI…

Cabo Verde Kyrgyz Republic Solomon Islands

Cambodia Lao PDR Sudan
Cameroon Lesotho Timor-Leste
Comoros Mauritania Tunisia
Congo, Rep. Micronesia, Fed. Sts. Ukraine
Cote d’Ivoire Moldova Uzbekistan
Djibouti Mongolia Vanuatu
Egypt, Arab Rep. Morocco Vietnam
El Salvador Myanmar West Bank and Gaza
Eswatini Nicaragua Zambia
Ghana Nigeria Zimbabwe
Honduras Pakistan

Upper-Middle Income Countries

Albania Fiji Namibia
Algeria Gabon Nauru
American Samoa Georgia North Macedonia
Argentina Grenada Paraguay
Armenia Guatemala Peru
Azerbaijan Guyana Romania
Belarus Iran, Islamic Rep. Russian Federation
Belize Iraq Samoa
Bosnia and Herzegovina Jamaica Serbia
Botswana Jordan South Africa
Brazil Kazakhstan Sri Lanka
Bulgaria Kosovo St. Lucia
St. Vincent and the
China Lebanon
Grenadines
Colombia Libya Suriname
Costa Rica Malaysia Thailand
Cuba Maldives Tonga
Dominica Marshall Islands Turkey
Dominican Republic Mauritius Turkmenistan
Ecuador Mexico Tuvalu
Equatorial Guinea Montenegro Venezuela, RB

Note: Upper middle-income countries will be eligible to access the Ceiling Price for
procurements through United Nations-related organization, non-governmental organizations
and not-for-profit organizations, development and/or public health financing mechanisms, or a

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8/27/2020 Unitaid and CHAI announce agreement with Omega Diagnostics to increase access to new, instrument-free CD4 test for people living with HI…

procurement agent appointed by any of these entities. South Africa is the exception to this
stipulation and will be eligible to access the Ceiling Price through all Eligible Buyers defined
above.

*This initiative aims to catalyze access to an affordable advanced HIV disease package of care inclusive of

optimized screening tests for key opportunistic infections, with associated preventative and treatment

options. This is achieved through market shaping efforts on key diagnostic and treatment products and

country support to create an enabling environment for product demand and uptake.

This press release was updated at 3:00pm EST, on May 4, 2020.

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