Enzo Biochem公司丙肝定量检测新技术获批

  近日，Enzo Biochem公司宣布，他们进行丙肝病毒定量检测的AmpiProbe-HCV检测技术已经获得了纽约州卫生部门的批准；AmpiProbe是由科学家们开发的专门的核酸扩增和检测的平台，该技术得以批准意味着Enzo Biochem公司就可以将这项检测技术提供给纽约州的居民们。
  Enzo公司CEO Elazar Rabbani在一项声明中指出，AmpiProbe-HCV技术的批准是我们业务发展的一个重要的里程碑，由于当前国立的临床实验室的还款压力不断增大，我们希望这项技术可以会对市场带来一定影响，同时也帮助实验室寻求低价创新性的解决策略。
  这种新型技术检测HCV的标准已经可以低至每毫升血清中5.5个国际单位（IU），而且检出的阳性率大约95%，同时最低定量浓度也可以达到10IU/mL，这要比美国当前的商业实验更为敏感；此外该项技术所用的样本材料要比当前临床实验室中的要少，这就可以使得研究者们利用原样品来进行额外的测试。
  Enzo公司表示，验证实验可以通过标准的实验设备来完成，并不需要进行专门的培训，而且该技术可以覆盖所有相关基因型的病毒；据美国CDC数据显示，目前在美国有超过270万人感染了HCV，而治疗手段仅依赖于再发性地检测。（转化医学网360zhyx.com）
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Enzo Biochem Lands NY State Approval of HCV Quantitative Test

Enzo Biochem today announced that the New York State Department of Health has granted approval of its AmpiProbe-HCV assay for quantitative detection of Hepatitis C virus.

AmpiProbe is the firm's proprietary nucleic acid amplification and detection platform developed by scientists at the New York-based company. The approval means the firm can offer its test to residents of the state of New York.

"The approval of AmpiProbe-HCV is an important milestone for our business," Enzo CEO Elazar Rabbani said in a statement. "Given the ever increasing reimbursement pressures on the nation's clinical laboratories, we expect this product as well as other products emerging from Enzo's platforms, including AmpiProbe, to have a significant impact on the market as these labs seek low-cost, innovative solutions."

Enzo said in a statement that the assay was shown to detect HCV at a level as low as 5.5 International Units per ml of serum with a positive rate greater than 95 percent, while the limit of quantification was 10 IU/ml, which is more sensitive than leading commercially available assays in the US. Moreover, the assay uses less sample material than leading tests currently offered in clinical laboratories, allowing for additional testing from the original sample.

The validation was carried out on standard laboratory equipment, requiring no specialized training or adjustments, Enzo said, adding that the test covers all of the relevant genotypes of the virus, as well as the major subtypes seen globally.

According to the US Centers for Disease Control and Prevention, there are over 2.7 million people in the US chronically infected with HCV. Treatment for those infected relies on recurrent testing.

Enzo said it's looking to expand its AmpiProbe test menu, including assays to detect Hepatitis B and HIV viral loads and a women's health panel.