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FDA Approves First Combined Test for HIV Diagnosis and Viral Load Monitoring

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November 20, 2020

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Hologic has announced that it has received additional FDA approval for the HIV-1 viral load monitoring assay.

The· Aptima HIV-1 Quant Dx Assay Currently, the diagnosis of HIV is also approved. This is the first dual-claim assay in the United States for diagnostic and viral load monitoring.

Molecular diagnostic tests are performed in Panther from fully automated samples to results According to Hologic, we systematize and use a dual-targeted approach to the HIV genome, designed to provide reliable, consistent, qualitative and quantitative results across the HIV-1 group.

This test was approved for viral load monitoring in late 2016.

According to Hologic, the use of assays to facilitate treatment at diagnosis is expected to reduce the risk of HIV transmission to others and “maximize long-term health prospects.”

“This is an exciting new claim to a sensitive and reliable HIV test because it has the potential to improve patient care.” Kevin Sonal, The president of Hologic’s diagnostic solution said in the release. “By measuring viral load at the same time as diagnosis, healthcare providers can guide treatment choices so that patients can start treatment immediately.”

“It will also benefit clinical laboratory customers who are continually striving to integrate testing into one automated platform as much as possible,” he said.

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