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Zeesan Biotech Wins China FDA Approval for HPV Genotyping Assay

NEW YORK (GenomeWeb) – A clinical assay from Zeesan Biotech to detect and identify 14 high-risk genotypes of human papillomavirus has been approved by the China State Food and Drug Administration, company announced recently.

The MeltPro High Risk HPV test, which was CE marked in 2015, is a single-tube, multiplex real-time PCR-based test that uses multicolor melt curve detection. It employs dry reagents, enabling PCR setup to be performed with a single DNA addition step, the Fujian, China-based firm said in a statement. As previously described, the test can be run on any thermal cycler, and it processes as many as 96 cervical swab samples in around 2.5 hours.

Persistent infection of high-risk HPV can cause cervical cancer, and screening is recommended for prevention and early intervention. Many existing assays call out a few common high-risk genotypes, such as HPV 16/18, and typically do not provide information on the identity of other strains present, Zeesan said.