Hologic's Global Access Initiative Increases Availability of Diagnostic Testing in Resource-Limited Countries

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• USA - English

Unveiled at the 2018 International AIDS Conference in Amsterdam, the Hologic Global Access Initiative will offer a single, all-inclusive pricing structure with no upfront cost or capital expenditure, providing access to four crucial molecular diagnostic tests across all eligible countries. This offers resource-limited countries a new, cost-effective way to mitigate the burden of infectious diseases with increased testing supply and superior technology.

"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," said Tom West, president, 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, which states that by 2020, 90 percent of people living with HIV will know their status, 90 percent of people with diagnosed HIV infection will receive sustained antiretroviral therapy, and 90 percent of people receiving antiretroviral therapy will have viral suppression. It also supports the objectives of the Unitaid-chaired Integrated Diagnostics Consortium by optimizing the efficiency of overall lab systems, reducing instrument downtime, and minimizing stockouts and waste.

"This initiative will provide significant savings to our partners that are scaling up HIV viral load testing. It will also enable countries to increase routine screening for hepatitis C and HPV. Since effective treatments are available for these diseases, early detection will save lives," said CHAI Vice President of Global Markets, Alan Staple.

The Value of the Aptima® Assays on the Panther® System
Expected to launch in August 2018, the program will expand access to Hologic's Panther system, a market-leading, integrated platform that fully automates molecular testing with true sample-to-result automation, adaptable workflow options, and a consolidated testing menu. Designed to be modular and scalable, the Panther system can accommodate the needs of large, centralized labs and smaller, decentralized labs alike. The Panther system 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.^2,3

Qualified assays available on the Panther system include:

• 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 diagnosis, confirmation and clinical management of HCV infection.
• The Aptima® HBV Quant assay to aid in the clinical management of HBV infection.
• The Aptima® HPV assay 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 offers the opportunity to simultaneously run multiple assays from one patient's blood sample, which improves productivity and accelerates results, 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 HIV and HCV. In the early 2000s, Hologic's portfolio evolved to include qualitative assays for HIV and HCV, and now also includes quantitative assays for HIV, HBV and HCV. Hologic also has a long-standing market leadership position in cervical cancer screening, including the Aptima HPV assay, which identifies high-risk HPV mRNA that is indicative of the HPV infections most likely to lead to cervical disease.⁴

About Hologic
Hologic, Inc. is an innovative medical technology company primarily focused on improving women's health and well-being through early detection and treatment. For more information on Hologic, visit www.hologic.com.

Forward-Looking Statements
This press release may contain forward-looking information that involves risks and uncertainties, including statements about the Hologic Global Access Initiative and use of the included diagnostic products. There can be no assurance that this initiative or the use of the included diagnostic products will achieve the benefits described herein or that such benefits will be replicated in any particular manner with respect to an individual patient. The actual effect of the initiative and/or the use of the products can only be determined on a case-by-case basis depending on the particular circumstances and patient in question. In addition, there can be no assurance that the initiative and/or the included diagnostic products will be commercially successful or achieve any expected level of sales. Hologic expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any such statements presented herein to reflect any change in expectations or any change in events, conditions or circumstances on which any such statements are based.

Hologic, Aptima, Panther and The Science of Sure are trademarks and/or registered trademarks of Hologic, Inc. in the United States and/or other countries.

*Currently not available for diagnostic use in the United States.

Investor Contact:
Michael Watts
+1 858.410.8588
[email protected]

Media Contact:
Jane Mazur
+1 508.263.8764 (direct)
+1 585.355.5978 (mobile)
[email protected]

References

1. WHO. Immunizations, vaccines and biologicals: HIV/AIDS. Accessed June 27, 2018. http://www.who.int/immunization/topics/hiv/en/index1.html.
2. Hologic, Inc. Data on File.
3. Ratnam S, et al. Workflow and maintenance characteristics of five automated laboratory instruments for the diagnosis of sexually transmitted infections. J Clin Microbiol. 2014;52(7); 2299-2304.
4. Aptima HPV assay [package insert]. AW-12820-001, Rev. 001. San Diego, CA: Hologic, Inc.; 2015. 

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