Hologic has received two new CE-Marks for its Aptima HIV-1 Quant Dx Assay in early infant diagnosis (EID) and to test dried blood spots (DBS) in Europe.
The assay is an in-vitro nucleic acid amplification test (NAAT) designed to detect and quantitate HIV type 1 (HIV-1) on the company’s Panther system.
The Aptima HIV-1 Quant Dx Assay has been designed to aid in HIV-1 diagnosis, as a confirmation of the infection, and as an aid in the clinical management of infected patients.
Furthermore, the test can be used along with clinical presentation and other laboratory markers for disease prognosis.
It is said to be the first dual-claim assay for early infant diagnosis as well as viral load.
The clearance allows the use of the assay for qualitative identification of HIV-1 RNA as an aid to diagnose HIV-1 infected infants aged less than 18 months.
In addition, the assay can be used to analyse an additional sample type (DBS) for monitoring viral load and disease progression in European and African patients infected with HIV-1.
The DBS claim is critical in the African market because it is a more stable and easily transportable, compared to liquid blood, Hologic noted.
Hologic Europe South and Indirect Markets vice-president João Malagueira said: “With 25 million people infected with HIV in sub-Saharan Africa alone, there continues to be an urgent need for accessible testing, which is crucial for managing care and reducing the spread of this life-threatening infection.
“These new product extensions, along with the recent announcement of our Hologic Global Access Initiative, underline Hologic’s commitment to providing accessible testing.”
The Hologic Panther system is a fully automated molecular testing device. It is said to feature high throughput, delivering up to 320 results in eight hours.