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GeneFirst Gets CE Mark for HPV Genotyping Assay

NEW YORK (GenomeWeb) – GeneFirst has announced that its test for high-risk human papillomavirus has received CE-IVD marking.

The Papilloplex HR-HPV Genotyping Kit detects and differentiates all 14 high-risk HPV genotypes implicated in cervical cancer. In an evaluation performed by the Oxford, England-based firm earlier this year, the single-tube multiplex test had a high level of agreement with four other HPV assays. The test uses GeneFirst's Multiplex Probe Amplification (MPA) technology, which allows for differentiation of up to six targets per fluorescence channel using target-specific PCR primers and probes.

"Launching the first product based on our patented MPA technology is a significant milestone for GeneFirst, and aligns with the company's strategic focus to drive forward new product development in the areas of oncology and infectious diseases," GeneFirst CEO Guoliang Fu said in a statement.

The kit is permitted for use with cervical swabs as well as the first portion of a urine sample, or first-void urine. For these samples, the test uses a collection device developed by Belgian firm Novosanis called Colli-Pee.

"Papilloplex will be the first CE-marked kit for HR-HPV that includes first-void urine as a sample type [and] Colli-Pee's ease of use fits perfectly in the overall strategy of Papilloplex HR-HPV," Novosanis CEO Vanessa Vankerckhoven added.