致善HPV基因分型检测取得IVD-CE认证 - 致善生物 - 官网

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2015-10-12

致善HPV基因分型检测取得IVD-CE认证

纽约(GenomeWeb)-致善生物今日发表通告称,该公司的高危型人乳头瘤病毒基因分型试剂盒通过IVD-CE认证。

这家位于中国厦门的公司生产的MeltPro High Risk HPV Genotyping Assay检测14种HPV基因型,并采用人的细胞基因作为内部阳性质控。该试剂需在公司的MeltPro系统上运行,该系统可以处理SurePath保存液(Becton Dickinson)以及新柏氏保存液(Hologic)保存的获得的宫颈细胞样本。

该试剂为冻干粉试剂,可在室温下进行保存,其采用单管多重实时PCR后进行多色熔解曲线分析。

该公司的声明称,这是致善的第二个通过CE认证的产品,第一个为检测 30种白血病融合基因的多重实时PCR检测试剂Q-fusion,这是一个与美国加州的QuanDx联合研制上市的产品。

该公司同时也开发了一种结核检测试剂,目前已通过临床验证,同时,还有α-和β-地中海贫血症检测试剂。

正如GenomeWeb先前报道,常规的HPV基因分型的受益,特别是HPV16和HPV18以外的基因型与宫颈癌的风险仍然是有争议的。

例如,美国FDA四月份批准了罗氏的Cobas HPV test作为25岁以上的女性宫颈癌的初筛,而不要求平行进行子宫抹颈片检查,引起了《临床微生物学杂志》关于此类问题展开了讨论。


报道原文如下:


      Zeesan HPV Genotyping Assay Gets CE-IVD Mark

      Sep 24, 2015

      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, asreported 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.