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 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.

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

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 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.