*ST東洋(002086.SZ):HIV檢測試劑獲得美國FDA批准
格隆匯 10 月 22日丨*ST東洋(002086.SZ)公佈,公司於近日收到美國食品藥品監督管理局(“美國FDA”)的通知,公司全資子公司美國Avioq,Inc.向美國FDA申報的新一代VioOne™ HIV檢測試劑(艾滋病檢測試劑)申請已獲得批准。此前,美國Avioq,Inc.已經取得上述HIV檢測試劑的歐盟CE認證。
新一代VioOne™ HIV檢測試劑(艾滋病檢測試劑)可以對人類血清或血漿中HIV-1(M組和O組)及HIV-2不同基因產物的抗體進行確認和區分,其作為更特異的補充檢測,用於確認診斷程序中重複反應性樣本中抗體的存在。獲得歐盟認證的新一代VioOne™ HIV檢測試劑可在單一檢測中同時實現補充檢測確認HIV抗體、區分HIV-1和HIV-2不同基因產物抗體、區分新發和長期存在的HIV-1感染並用於流行病學研究。
根據美國疾病控制與預防中心(“美國CDC”)2014年發佈的新版HIV檢測指南,檢測策略中第二步包含補充檢測,即通過檢測和區分HIV-1和HIV-2來確認重復有反應性的HIV-1/HIV-2樣本的篩查結果。美國CDC以往採用蛋白印跡法進行檢測,近年來藉助HIV-1/2免疫層析試驗進行。本公司獲得FDA批准的新一代VioOne™ HIV檢測試劑(VioOne™ HIV Profile™ Supplemental Assay)作為一種改良的檢測試劑,具備符合美國CDC檢測指南策略的優異性能。
此次新一代VioOne™ HIV檢測試劑獲得美國FDA批准,標誌着美國Avioq公司具備了在美國市場銷售上述產品的資格,上述產品上市銷售後將進一步增強公司的核心競爭力,並對公司未來的經營業績帶來積極影響,公司將積極推動上述產品在美國市場的上市銷售工作。
Follow us
Find us on
Facebook,
Twitter ,
Instagram, and
YouTube or frequent updates on all things investing.Have a financial topic you would like to discuss? Head over to the
uSMART Community to share your thoughts and insights about the market! Click the picture below to download and explore uSMART app!

Disclaimers
uSmart Securities Limited (“uSmart”) is based on its internal research and public third party information in preparation of this article. Although uSmart uses its best endeavours to ensure the content of this article is accurate, uSmart does not guarantee the accuracy, timeliness or completeness of the information of this article and is not responsible for any views/opinions/comments in this article. Opinions, forecasts and estimations reflect uSmart’s assessment as of the date of this article and are subject to change. uSmart has no obligation to notify you or anyone of any such changes. You must make independent analysis and judgment on any matters involved in this article. uSmart and any directors, officers, employees or agents of uSmart will not be liable for any loss or damage suffered by any person in reliance on any representation or omission in the content of this article. The content of the article is for reference only and does not constitute any offer, solicitation, recommendation, opinion or guarantee of any securities, virtual assets, financial products or instruments. Regulatory authorities may restrict the trading of virtual asset-related ETFs to only investors who meet specified requirements. Any calculations or images in the article are for illustrative purposes only.
Investment involves risks and the value and income from securities may rise or fall. Past performance is not indicative of future performance. Please carefully consider your personal risk tolerance, and consult independent professional advice if necessary.