Hologic Inc, Marlborough, Mass, has launched the Hologic Global Access Initiative, in partnership with the Clinton Health Access Initiative (CHAI) and the UK government-backed MedAccess, to increase affordable access to molecular testing for HIV, hepatitis B and C (HBV and HCV), and human papilloma virus (HPV) in nearly 50 nations around the world. Located primarily across Africa and Southeast Asia, the countries make up 90% of the global HIV disease burden.

Unveiled at the 2018 International AIDS Conference, the initiative will offer a single, all-inclusive pricing structure with no upfront costs or capital expenditure, facilitating access to four crucial molecular diagnostic tests across all eligible countries. The program will offer countries with limited resources a novel, cost-effective way to mitigate the burden of infectious diseases with an increased testing supply and superior technology.

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Tom West, Hologic.

“As a global leader in diagnostics, Hologic has the responsibility and privilege to serve people in need by providing accessible testing, which is crucial for managing care and reducing the spread of infectious diseases,” says Tom West, president of the diagnostic solutions division at Hologic. “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.”

The Hologic Global Access Initiative supports UNAIDS’ 90-90-90 goal: by 2020, 90% of people with HIV will know their status; 90% of people with HIV will receive sustained antiretroviral therapy; and 90% of people receiving antiretroviral therapy will have viral suppression. The initiative also supports the objectives of the Unitaid-chaired Integrated Diagnostics Consortium by optimizing the overall efficiency of lab systems, reducing instrument downtime, and minimizing stockouts and waste.

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Alan Staple, Clinton Health Access Initiative.

“This initiative will provide significant savings to partners who are scaling-up HIV viral load testing,” says Alan Staple, vice president for global markets at CHAI. “It will also enable countries to increase routine screening for HCV and HPV. Since effective treatments are available for these diseases, early detection will save lives.”

The collaboration highlights the value of the Aptima assays launched in August for the Hologic Panther system, including assays for HBV, HCV, HIV, and HPV. The Panther system is an integrated platform that brings to molecular testing true sample-to-result automation, adaptable workflow options, and a consolidated testing menu. Designed to be modular and scalable, Panther can accommodate the needs of large, centralized labs as well as smaller, decentralized labs. It also offers the highest output per square meter of any comparable molecular diagnostic instrument: up to 320 results in 8 hours in less than one square meter of space. Qualified assays available on the Panther instrument include:

  • Aptima HBV Quant to aid in the clinical management of HBV infection.
  • Aptima HCV Quant Dx to aid in the diagnosis, confirmation, and clinical management of HCV infection.
  • Aptima HIV-1 Quant Dx to aid in the diagnosis, confirmation, and clinical management of HIV-1 infection; currently unavailable for diagnostic use in the United States.
  • Aptima HPV to detect 14 high-risk HPV types that are associated with the development of cervical cancer.

Where coinfection is prevalent, Hologic’s suite of Aptima virology assays enables providers to simultaneously run multiple assays from a single patient blood sample, thereby improving productivity and accelerating results—and ultimately enhancing patient care.

Hologic has a long-term legacy in the virology space, beginning two decades ago and spanning development of the first nucleic acid tests to screen the blood supply for HCV and HIV. In the early 2000s, Hologic’s portfolio evolved to include qualitative assays for HCV and HIV, and it now also includes quantitative assays for HBV, HCV, and HIV. Hologic also has a long-standing market leadership position in cervical cancer screening, including the Aptima HPV assay, which identifies the high-risk HPV mRNA indicative of HPV infections most likely to lead to cervical disease.

To learn more, visit Hologic.