Global Fund, USAID and Stop TB Partnership's new collaboration with Molbio Diagnostics will increase access to rapid molecular tests for TB

Although rapid molecular tuberculosis (TB) tests are endorsed by the World Health Organization (WHO) as the standard of care, less than 40% of people in need of TB testing in 2021 had access to a rapid molecular diagnostic test. Major barriers in expanding access to testing include high operating costs, infrastructure challenges and inefficient executions. This significant gap in access to rapid molecular testing for TB and drug resistance stands as one of the largest shortfalls in the global TB response today.

In 2020, WHO endorsed three of Molbio Diagnostics’ rapid molecular Truenat® assays (Truenat® MTB, MTB Plus and MTB-RIF Dx) for the initial diagnosis of TB and subsequent detection of rifampicin resistance in adults and children with signs and symptoms of pulmonary TB. With the WHO recommendation, Molbio Diagnostics is positioned as a welcomed new key player to fight TB worldwide.

As part of this collaboration, the Global Fund and the Stop TB Partnership will sign new deals with Molbio Diagnostics to:

• Provide Truenat® MTB, MTB Plus and MTB-RIF Dx tests at the reduced price in all countries supported by the Global Fund, Stop TB Partnership and USAID.
• Reinforce commitment to service and maintenance by providing a global standard service level agreement with defined key performance indicators.
• Extend similar pricing to public and private sector buyers, where terms are applicable.

USAID, in collaboration with ministries of health and partners, will continue to provide critical guidance and best practices on the introduction and scale-up of the Truenat® system in a range of high TB burden settings to increase access through network development, health care worker training, quality assurance monitoring and support.

Welcoming this news, Executive Director of the Global Fund Peter Sands said, “We are delighted to partner with Molbio Diagnostics. They play a crucial role in meeting the need for improved diagnostic solutions and technologies. We look forward to making these TB products more affordable and accessible in the countries where we invest.”

“USAID is committed to creating a TB-free world, and that starts with expanding access to critical diagnostic testing to reach every person with TB," said Dr. Atul Gawande, USAID's Assistant Administrator for Global Health. "This new technology will allow countries to expand rapid TB diagnostic testing to more rural, hard-to-reach populations at the primary care level –and at a significantly lower cost than current testing options.”

“This is a historical moment,” said Dr. Lucica Ditiu, Executive Director of the Stop TB Partnership. “For the first time ever, we have a rapid molecular test for TB and rifampicin resistance that is less than US$8 per test, more than 20% lower than what is currently available on the market for these types of tests. We also have an amazing ‘package of services’ offered by Molbio, and a commitment to offer low prices for private sector providers. We are thrilled by this collaboration with a company from the highest TB burden country that fully understands the need for securing access to a rapid molecular diagnosis for everyone in need. I hope we all feel now even more comfortable saying ‘Yes! We can end TB.’”

About USAID

As the largest bilateral funder of TB efforts, USAID leads the U.S. government’s global TB efforts by working with agencies and partners around the world on the shared goals of reaching every person with the disease, curing those in need of treatment, and preventing the spread of new infections and the progression to active TB disease. 

About the Stop TB Partnership 

The Stop TB Partnership brings together expertise from a broad spectrum of country, regional, and global partners in our shared mission to revolutionize the TB space and end TB by 2030. Founded in 2001, the Stop TB Partnership is a United Nations-hosted organization that takes bold and smart risks to serve the needs and amplify the voices of the people, communities, and countries affected by TB. We work to advocate, catalyze, and facilitate sustained coordination and collaboration among partners; to support the development, replication, and scale-up of innovative approaches and tools; and to facilitate equitable access to TB diagnostics, treatment, and care for all in need, including through our Global Drug Facility (GDF), the largest pooled procurement mechanism for TB medicines and diagnostics. The Stop TB Partnership Secretariat is hosted and administered by UNOPS. 

About Molbio Diagnostics

Molbio Diagnostics, based in India, brings to healthcare professionals worldwide the Truenat® technology that makes Real-Time PCR testing possible at the point-of-care - in all laboratories, in the field and in near-patient settings. With a large and growing menu of Truenat® assays for TB and 30+ infectious diseases, including COVID-19, HIV, HCV, HBV, HPV, Influenza, etc., this rapid, portable technology enables early and accurate diagnosis and initiation of correct treatment right at the first point of contact.

Truenat® is infrastructure independent and provides a complete end-to-end solution for disease diagnosis. The battery operated and intelligent design of the hardware and the room-temperature stable reagent microchip makes the assay robust and affordable. With the proven ability to work even at Primary Health Centers and with wireless data transfer capability, this game-changing technology brings a paradigm shift to the global fight to control and manage devastating infectious diseases.

Source: Global Fund