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Systaaq HBV Assay Receives CE Mark

NEW YORK (GenomeWeb) — Systaaq Diagnostic Products announced on Monday that it has received CE marking for its real-time PCR-based hepatitis B diagnostic.

The assay is designed to quantitate HBV DNA in serum or plasma to assist in the treatment of chronic HBV-infected patients receiving antiviral therapy, the Manassas, Virginia-based company said. Systaaq received CE marking for its RT-PCR-based hepatitis C quantitative assay in August.

"With [their] high sensitivity and specificity … these tests can play a transformative role in the way healthcare providers [diagnose] the infections at a very early stage," Danial Richardson, chairman of Systaaq's scientific advisory board, said in a statement.

Systaaq also offers qualitative PCR-based assays for HIV-1 and dengue, according to the company’s website.