Hologic’s Global Access Initiative increases Availability of Diagnostic Testing in Resource-Limited Countries

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Program focuses on infectious disease assays – including HIV – for countries where critical testing is needed most

Hologic, Inc. has announced today the launch of the new Hologic Global Access Initiative, in partnership with the Clinton Health Access Initiative (CHAI) and MedAccess (backed by the U.K. government), to increase affordable access to molecular testing for HIV, hepatitis B and C (HBV and HCV) and human papillomavirus (HPV) in nearly 50 nations around the world. These countries, primarily across Africa and Southeast Asia, make up 90 percent of the HIV disease burden globally.

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.

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 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

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