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Medical Devices / Submissions and Approvals

Hologic’s HIV-1 Assay Receives Two CE Marks

Feb. 15, 2019

Hologic’s HIV-1 Quant Dx assay has been granted two new CE Marks — one for early infant diagnosis and another for testing dried blood spots (DBS).

The assay can now be used to qualitatively detect HIV-1 RNA in infants under 18 months old that have the disease and test an additional sample type, DBS, to monitor viral load and disease progression in infected individuals.

The company said the assay is the first and only diagnostic test with dual-claims for both viral load and early infant diagnosis.

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