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Zeesan HPV Genotyping Assay Gets CE-IVD Mark

NEW YORK (GenomeWeb) – Zeesan Biotech has released a high-risk human papillomavirus genotyping test as a CE-IVD product, the company announced today.

The Xiamen, China-based firm's MeltPro High Risk HPV Genotyping Assay tests for 14 types of HPV, with a cellular gene used as an internal positive control. It runs on the firm's MeltPro System, and processes cervical cell specimens collected in Becton Dickinson's SurePath preservative or derived from the Hologic Thinprep Pap test.  

The assay is a single-tube, multiplex qPCR followed by multicolor melt curve analysis, and is provided in a dry reagent format that can be stored at room temperature.

This is the second CE-marked product from Zeesan, the firm noted in a statement. The first is a multiplex qPCR test kit to identify 30 leukemic fusion genes, called Q-fusion, which was co-developed and marketed with California-based QuanDx.

The firm also makes a tuberculosis assay that was recently clinically validated, as well as multiplex tests for alpha- and beta-thalassemia.

The benefits of routine HPV genotyping, particularly for genotypes besides the HPV 16 and HPV 18 associated with the highest cervical cancer risk, are still debated, as reported by GenomeWeb.

The US Food and Drug Administration approval of the Roche Cobas HPV test for primary cervical cancer screening without requirement a parallel Pap test in women over 25 years in April prompted an airing of these issues in the Journal of Clinical Microbiology, for example.