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Pricing Agreement Expected to Broaden Access to Hologic Infectious Disease Tests

NEW YORK (GenomeWeb) – A pricing agreement announced today at the 2018 International AIDS Conference is expected to significantly reduce the cost of diagnostic testing for HIV/AIDS, hepatitis, and cervical cancer for millions of people.

Under the agreement, public sector programs in Zambia, Malawi, Tanzania, Uganda, and Zimbabwe will obtain access to Hologic's integrated molecular Panther system at $12 per patient sample and without paying upfront costs or investing in capital equipment.

The pricing agreement is part of a larger Hologic Global Access Initiative that also launched today with a goal of eventually extending agreements to the 50 low- and middle-income countries that make up 90 percent of the HIV disease burden, Hologic said in a statement.

The pricing agreement was announced by the United Kingdom's Department for International Development, Unitaid, UK government-backed social finance company MedAccess, the Clinton Health Access Initiative (CHAI), the US President’s Emergency Plan for AIDS Relief, the African Society for Laboratory Medicine, and the government of Zambia.

The agreement is expected to provide affordable access to molecular testing for HIV, hepatitis B and C, and human papillomavirus, the leading cause of cervical cancer, and the overall approach could generate faster results, strengthen health systems, and lower costs to  help scale up viral load testing and improve treatment monitoring for hundreds of thousands of patients in the next three years, according to the participating organizations.

Hologic said that its Global Access Initiative offers resource-limited countries a new, cost-effective way to mitigate the burden of infectious diseases with increased testing supply. It noted that the program will expand access to its Panther integrated platform, a fully automated nucleic acid testing with adaptable workflows and a consolidated testing menu. The Panther system accommodates large, centralized labs and smaller, decentralized labs because it is designed to be modular and scalable, the firm said.

As part of the new agreement, Hologic's Global Access Initiative will provide access within eligible countries to four Aptima molecular diagnostic tests running on the Panther system. They are the Aptima HIV-1 Quant Dx assay to aid in the diagnosis, confirmation, and clinical management of HIV-1 infection; the Aptima HCV Quant Dx assay to aid in the confirmation and clinical management of HCV infection; the Aptima HBV Quant assay to aid in the clinical management of HBV infection; and the Aptima HPV assay to detect 14 high-risk HPV types that are associated with the development of cervical cancer.

Where coinfection is prevalent, clinicians can simultaneously run multiple tests from one patient’s blood sample using Aptima virology assays, which improves productivity, accelerates results, and ultimately enhances patient care, Hologic said.

"Through this initiative in partnership with the global public health community, we're determined to make an even greater impact in countries with limited resources and help reduce the burden of global infectious diseases, especially HIV," Tom West, president of the diagnostic solutions division at Hologic, said in a statement.

The WHO has recommended molecular diagnostic viral load testing as the gold standard for monitoring the effectiveness of treatment for HIV. Today only 56 percent of people living with HIV have routine access to viral load testing.

The new initiative is expected to launch next month. At least five countries in sub-Saharan Africa are expected to introduce Hologic testing this year as part of their viral load scale-up programs in 2018. With funding and support from the President’s Emergency Plan for AIDS Relief, Zambia will be the first country to implement the Panther platform for routine viral load testing under an all-inclusive pricing contract. Unitaid, through a competitive process conducted by UNICEF, selected Hologic to pilot the all-inclusive pricing approach for different tests in Malawi, Tanzania, Uganda, and Zimbabwe.

The initiative will also enable countries to increase routine screening for hepatitis C and HPV, Alan Staple, vice president of global markets with the Clinton Health Access Initiative, said in a statement. "Since effective treatments are available for these diseases, early detection will save lives," he said.

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