Aptima® HIV-1 Quant Dx Assay Awarded WHO Prequalification for Dried Blood Spot Samples

MARLBOROUGH, Mass.–(BUSINESS WIRE/AETOSWire)– Hologic, Inc. (Nasdaq: HOLX) announced today that its CE-marked Aptima® HIV-1 Quant Dx assay has been awarded World Health Organization (WHO) prequalification for testing of dried blood spot (DBS) samples.

The Aptima® HIV-1 Quant Dx assay can be used with DBS samples to monitor viral load and disease progression among HIV-1 infected individuals, and to aid in the diagnosis of HIV-1 infected infants under 18 months. It is the first and only dual-claim assay for both viral load and early infant diagnosis (EID).

DBS sampling improves access to HIV diagnostic testing and care, particularly among HIV-infected populations living in remote areas. DBS samples are more stable and easily transportable compared to liquid whole blood or plasma samples. A finger stick or heel prick produces an adequate sample that is dried on a specially designed card. The DBS samples do not require refrigeration and when stored properly can withstand extreme conditions, including excess heat and humidity.

This additional approval is notable for the African market, where DBS is the primary sample type in several countries, and is expected to enable countries to expand their use of the Aptima® HIV-1 Quant Dx assay, the leading assay under Hologic’s Global Access Initiative (GAI). The GAI launched in 2018 and offers customers a single, all-inclusive pricing structure with no upfront cost or capital expenditure. Qualified products include molecular assays for HIV, Hepatitis B and C, and human papillomavirus (HPV), as well as the ThinPrep® Pap test for cervical cancer screening.

“With 25 million people infected with HIV in sub-Saharan Africa, there continues to be an urgent need for access to cost-effective and quality diagnostic testing,” said Joao Malagueira, vice president, Europe South, Middle East and Africa. “The ability to test DBS samples underlines Hologic’s commitment to promote simple, scalable and sustainable solutions for countries that need it most. The new product extension will ultimately enhance patient care and allow for partner governments to mitigate the burden of disease and respond to broader health needs.”

Despite substantial progress toward the UNAIDS 95-95-95 targets, there continue to be gaps across the HIV testing and treatment cascade, with 15.7 million people living with HIV who have an unsuppressed viral load globally1. In addition, children and infants continue to be affected by the epidemic. In 2019, only 60% of infants born to pregnant women living with HIV received the recommended HIV test within two months of birth2. About 86% of the estimated 160,000 children newly infected with HIV in 2018 were in sub-Saharan Africa.3

The DBS sample type is the second approval Hologic has received from the WHO, following prequalification of the Aptima® HIV-1 Quant Dx assay for in vitro diagnostic use with plasma samples in December 2017.