bioMONTR Labs宣布了针对乙型肝炎前基因组RNA定量的新分析

StephenW

bioMONTR Labs Announces New Assay for Hepatitis B Pregenomic RNA Quantitation

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Apr 08, 2019, 08:00 ET

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RESEARCH TRIANGLE PARK, N.C., April 8, 2019 /PRNewswire/ -- bioMONTR Labs is pleased to announce that we have completed the analytical validation of our new assay for the detection and quantitation of Hepatitis B pregenomic RNA in chronic HBV (CHB) patients. This first-of-its-kind HBV pgRNA Research Use Only (RUO) assay utilizes automated extraction, and proprietary, specially designed oligos, and real-time PCR for HBV pgRNA quantitation. The results of our analytical validation study will be presented at the ASM sponsored 2019 Clinical Virology Symposium in Savannah, Georgia.  

Recent studies indicate HBV pgRNA may be a useful clinical biomarker in evaluating CHB patient response to treatment with nucleos(t)ide analogues (NA). NA treatment suppresses viral replication by blocking HBV DNA synthesis but does not affect transcription of HBV pgRNA. Further, it has been proposed that pgRNA serves as a surrogate marker for cccDNA and provides a direct assessment of infection status during treatment of CHB without the need for liver biopsies. This automated method provides reproducible results from patient plasma or serum with high sensitivity and specificity. Results from testing CHB patient samples suggest that this high-throughput RUO method will allow the evaluation of HBV pgRNA in patients on NA treatment as a clinical biomarker in drug development studies.

"bioMONTR Labs is pleased to present the results of this validation study," said Daniel McClernon, President and CSO of bioMONTR Labs. "I am immensely proud of this milestone. We expect that the detection of pgRNA will be an important biomarker utilized in new drug development for chronic HBV patients."

About bioMONTR Labs

bioMONTR Labs is a privately owned, CLIA Certified lab located in Research Triangle Park, North Carolina. The company offers a comprehensive menu of high-complexity, molecular-based assays, as well as other proprietary and esoteric testing. For more information on the company, its management, test menu and capabilities, please visit www.biomontr.com.

StephenW

bioMONTR Labs宣布了针对乙型肝炎前基因组RNA定量的新分析

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bioMONTR实验室

2019年4月8日，东部时间08:00

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南卡罗来纳州研究三角公园，2019年4月8日/美通社/  -  bioMONTR Labs很高兴地宣布，我们已经完成了我们用于检测和定量慢性HBV（CHB）患者中乙型肝炎前基因组RNA的新检测方法的分析验证。这种首创的HBV pgRNA仅供研究使用（RUO）检测采用自动提取，专有的，专门设计的寡核苷酸，以及用于HBV pgRNA定量的实时PCR。我们的分析验证研究结果将在ASM赞助的佐治亚州萨凡纳举办的2019年临床病毒学研讨会上公布。

最近的研究表明，HBV pgRNA可能是评估CHB患者对核苷（酸）类似物（NA）治疗反应的有用临床生物标志物。 NA治疗通过阻断HBV DNA合成来抑制病毒复制，但不影响HBV pgRNA的转录。此外，已经提出pgRNA用作cccDNA的替代标记，并且在不需要肝脏活组织检查的情况下提供CHB治疗期间感染状态的直接评估。该自动化方法以高灵敏度和特异性提供来自患者血浆或血清的可重复结果。测试CHB患者样本的结果表明，这种高通量RUO方法将允许在NA治疗患者中评估HBV pgRNA作为药物开发研究中的临床生物标志物。

“bioMONTR Labs很高兴地介绍这项验证研究的结果，”bioMONTR实验室总裁兼CSO Daniel McClernon说。 “我对这一里程碑感到非常自豪。我们预计pgRNA的检测将成为慢性HBV患者新药开发中使用的重要生物标志物。”

关于bioMONTR实验室

bioMONTR Labs是一家私人拥有的CLIA认证实验室，位于北卡罗来纳州的Research Triangle Park。该公司提供全面的高复杂性，基于分子的分析，以及其他专有和深奥的测试。有关该公司，其管理，测试菜单和功能的更多信息，请访问www.biomontr.com。