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Hologic's Aptima HIV-1 Quant Dx Assay Receives Two CE Marks, Making It the First and Only Dual-Claim Assay for Both Viral Load and Early Infant Diagnosis.

M2 PHARMA-February 19, 2019-Hologic's Aptima HIV-1 Quant Dx Assay Receives Two CE Marks, Making It the First and Only Dual-Claim Assay for Both Viral Load and Early Infant Diagnosis

(C)2019 M2 COMMUNICATIONS

- US-based medical technology company Hologic, Inc.'s (NASDAQ: HOLX) Aptima HIV-1 Quant Dx Assay has received two new CE marks in Europe for early infant diagnosis and for testing dried blood spots.

This means the assay can be used to qualitatively detect HIV-1 RNA as an aid in the diagnosis of HIV-1 infected infants under 18 months old, and to test an additional sample type to monitor viral load and disease progression in HIV-1 infected individuals in European and African countries.

It is the first and only dual-claim assay for both viral load and early infant diagnosis.

The dried blood spot claim is particularly important in the African market as it is a much more stable and easily transportable sample type than liquid blood.

The Aptima HIV-1 Quant Dx assay is an in vitro nucleic acid amplification test for the detection and quantitation of HIV type 1 (HIV-1) on the fully automated Panther system.

It is intended as an aid in the diagnosis of HIV-1 infection, as a confirmation of HIV-1 infection, and as an aid in the clinical management of patients infected with HIV-1.

The Aptima HIV-1 Quant Dx assay may also be used in conjunction with clinical presentation and other laboratory markers for disease prognosis in HIV-1 infected individuals.

The Aptima HIV-1 Quant Dx assay was awarded World Health Organization prequalification for in vitro diagnostics using plasma samples on December 21, 2017.

This means that the assay meets WHO standards of quality, safety, performance and reliability, and allows global health organizations to consider the Aptima HIV-1 Quant Dx assay for public sector procurement in resource-limited settings.

The Aptima HIV-1 Quant Dx assay is processed on 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 broad testing menu. The Panther system is designed to be modular and scalable, accommodating the needs of large, centralised labs as well as smaller, decentralized labs.

The Panther system offers the highest throughput per square meter of any comparable molecular diagnostic instrument up to 320 results in 8 hours in less than one square meter of space.

Hologic has a long-term legacy in the virology space that began two decades ago and spans development of the first NAATs to screen the blood supply for HIV and HCV (hepatitis C virus).

In the early 2000s, Hologic's diagnostic portfolio evolved to include qualitative assays for HIV and HCV, and now also includes quantitative assays for HIV, HBV (hepatitis B virus) and HCV.

Hologic, Inc. is a medical technology company primarily focused on improving women's health and well-being through early detection and treatment.

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, less costly way to mitigate the burden of infectious diseases with increased testing supply and superior technology.

UNAIDS' 95-95-95 goal states that by 2030, 95 per cent of people living with HIV will know their status, 95 per cent of people with diagnosed HIV infection will receive sustained antiretroviral therapy, and 95 per cent of people receiving antiretroviral therapy will have viral suppression.

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Publication:M2 Pharma
Date:Feb 19, 2019
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