Roche获得FDA批准的Cobas MPX测试

StephenW

Roche Receives FDA Approval for Cobas MPX Test
Oct 21, 2016
| a GenomeWeb staff reporter

NEW YORK (GenomeWeb) – Roche announced today that it has received approval from the US Food and Drug Administration for its Cobas MPX test, a nucleic acid test for the detection of HIV, hepatitis B, and hepatitis C in human blood plasma and serum.

The assay, which is approved for use on the company's Cobas 6800 and 8800 systems, allows screening labs in the US to use advanced PCR-based diagnostic technology to screen donated blood and plasma, to prevent the spread of HIV-1 and HIV-2, HBV, and HCV through transfused blood products.

"This approval reinforces our strong presence in donor screening, and underscores our ability to provide proven, robust technology for the testing of donated blood and blood products," Uwe Oberlaender, head of Roche Molecular Diagnostics, said in a statement. "We will continue to partner with donor screening laboratories worldwide demonstrating our joint commitment to patient safety."

The Cobas 6800 and 8800 molecular diagnostic platforms and associated hepatitis B and hepatitis C viral load assays received FDA approval in October 2015.

StephenW

Roche获得FDA批准的Cobas MPX测试
2016年10月21日
|一个GenomeWeb的工作人员记者

纽约（GenomeWeb） - 罗氏今天宣布，已经获得美国食品和药物管理局批准的Cobas MPX试验，该试验是在人血浆和血清中检测HIV，乙型肝炎和丙型肝炎的核酸试验。

该测定被批准用于公司的Cobas 6800和8800系统，允许在美国的筛查实验室使用先进的基于PCR的诊断技术筛选捐赠的血液和血浆，以防止HIV-1和HIV-2的扩散，HBV和HCV通过输血的血液制品。

罗氏分子诊断公司负责人Uwe Oberlaender在一份声明中说：“这一批准增强了我们在捐赠者筛查方面的强大实力，并强调了我们为捐献的血液和血液制品提供成熟可靠的技术的能力。 “我们将继续与世界各地的捐赠者筛选实验室合作，展示我们对患者安全的共同承诺。

Cobas 6800和8800分子诊断平台和相关的乙型肝炎和丙型肝炎病毒载量测定在2015年10月获得FDA批准。

四十己过

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