FDA批准Hologic乙型肝炎病毒载量测定

StephenW

FDA Grants Approval for Hologic Hepatitis B Viral Load Assay              Jan 25, 2018
      

|               staff reporter
      


                                                                      NEW YORK (GenomeWeb) – Hologic said today that the US Food and Drug Administration has granted premarket approval for its Aptima HBV Quant Assay for quantitation of hepatitis B viral load on its fully automated Panther system.
The assay reliably quantitates HBV DNA across genotypes A-H, provides a dual-target approach that delivers accurate quantitation over a broad linear range, and tolerates potential mutations in the HBV genome, Hologic said.
The firm noted that the assay's linear range, from 10 IU/mL to 1 billion IU/mL, helps ensure precise quantitation even for samples with the high viremia often associated with chronic HBV infection.
Tom West, president of the diagnostic solutions division at Hologic, said in a statement that the approval means that the three major viral load assays that most laboratories run for patients are now available on a single system.
With the Panther system, labs can run viral load assays for HIV-1, HCV, and HBV in parallel or from a single patient sample.
"We hear repeatedly from clinical laboratory customers that menu consolidation is a top priority," West said. "Offering a robust virology and women's health menu on a single automated platform will enable them to reach their efficiency goals."
The assay joins a previously approved Aptima HIV-1 Quant Assay for human immunodeficiency virus and Aptima HCV Quant Dx Assay for hepatitis C virus on the Panther system's viral load menu. All three assays use real-time transcription-mediated amplification, which the firm said provides highly sensitive and specific performance.
Piper Jaffray analyst William Quirk wrote in a research note today that HBV is the lowest volume of the three Hologic viral load assays but critical to the firm gaining share of the approximately $500 million US market. He noted that labs historically are resistant to change vendors without all three approvals. The investment bank believes Hologic "could transform this market much like it has in the domestic HPV and CT/NG markets," he said.
In Europe, the Aptima HBV Quant assay is CE-IVD marked for viral-load monitoring.

      

StephenW

FDA批准Hologic乙型肝炎病毒载量测定
2018年1月25日
记者

（纽约）（GenomeWeb） - Hologic今天说，美国食品和药物管理局已经批准其Aptima HBV Quant Assay在其全自动Panther系统上定量检测乙肝病毒载量。

该检测方法能够可靠地定量跨越基因型A-H的HBV DNA，提供双靶方法，能够在广泛的线性范围内提供准确的定量，并且耐受HBV基因组中的潜在突变。

该公司指出，该检测线性范围从10 IU / mL到10亿IU / mL，有助于确保精确的定量，即使对于高病毒血症的样本通常与慢性HBV感染相关。

Hologic诊断解决方案部门总裁汤姆·韦斯特（Tom West）在一份声明中表示，该批准意味着大多数实验室针对患者运行的三种主要病毒载量检测方法现在可以在单一系统上使用。

借助Panther系统，实验室可以同时或从单个患者样本中运行HIV-1，HCV和HBV的病毒载量检测。

West说：“我们多次从临床实验室客户那里听到菜单整合是重中之重。 “在单一的自动化平台上提供强大的病毒学和女性健康菜单将使他们达到他们的效率目标。”

该试剂加入先前批准的用于人类免疫缺陷病毒的Aptima HIV-1定量测定和在Panther系统的病毒载量菜单上用于丙型肝炎病毒的Aptima HCV定量Dx测定。所有三种测定使用实时转录介导的扩增，该公司表示提供高度敏感和特定的性能。

Piper Jaffray分析师William Quirk今天在一份研究报告中写道，三种Hologic病毒载量检测方法的检测量最低，但对于该公司获得大约5亿美元市场份额至关重要。他指出，如果没有三个审批，实验室历来都不愿意改变供应商。他说，投资银行认为Hologic“可以像在国内的HPV和CT / NG市场一样改变这个市场。”

在欧洲，Aptima HBV Quant检测是CE-IVD标记用于病毒载量监测。

MP4

豪洛捷Gen-Probe（HOLOGIC Gen-Probe）前身为Gen-Probe公司，总部设在美国圣地亚哥市，创立于1983年，其秉承在专注的领域尽量做到第一的专业精神，自创立之初即保持全球分子诊断行业的领导地位至今，并曾荣获美国布什总统授予“2004年美国国家技术奖“。

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