Skip to main content
Premium Trial:

Request an Annual Quote

ViroSeq Gets FDA Clearance for use on ABI s 3700 DNA Analyzer

NEW YORK, June 25 - Celera Diagnostics today said that the US Food and Drug Administration has granted an additional marketing clearance for the company's ViroSeq HIV-1 genotyping system, a molecular diagnostic.

 

The 510(k) clearance covers the use of the ViroSeq system with the ABI Prism 3700 DNA analyzer, a product sold by Celera of Alameda, Calif., a joint venture between Applied Biosystems Group, Celera Genomics of Applera, and Abbott Laboratories. Abbott distributes the test, which is used to monitor and treat HIV infection.

 

The FDA cleared the ViroSeq system for marketing in December as an in vitro  diagnostic. ViroSeq uses DNA sequencing technology to identify strains of the HIV-1 virus, targeting regions of the viral genome associated with drug-resistant mutations. Some 150,000 HIV genotyping tests are conducted each year, according to Celera.
The Scan

Push Toward Approval

The Wall Street Journal reports the US Food and Drug Administration is under pressure to grant full approval to SARS-CoV-2 vaccines.

Deer Exposure

About 40 percent of deer in a handful of US states carry antibodies to SARS-CoV-2, according to Nature News.

Millions But Not Enough

NPR reports the US is set to send 110 million SARS-CoV-2 vaccine doses abroad, but that billions are needed.

PNAS Papers on CRISPR-Edited Cancer Models, Multiple Sclerosis Neuroinflammation, Parasitic Wasps

In PNAS this week: gene-editing approach for developing cancer models, role of extracellular proteins in multiple sclerosis, and more.