AdvanDx
AdvanDx為危及生命的血流感染的診斷和治療提供先進的分子診斷產品
一種剛面市的分子診斷檢驗不到90分鐘就能在陽性血液培養物中鑒定出三種不同的革蘭氏陰性菌。
它與高靈敏度、高特異性的熒光原位雜交(FISH)結合,用肽核酸(PNA)探針靶向活細菌和活酵母中的菌種特異性核糖體核糖核酸(rRNA)。
這種GNR信號燈PNA FISH檢驗可直接在含革蘭氏陰性桿菌的陽性血液培養物中同時鑒定大腸桿菌、肺炎克氏桿菌和綠膿桿菌。PNA探針的肽骨架具有獨特性質,能在極其復雜的樣本基質(如血液和血液培養物)中使用FISH檢驗,這進而有利于開發極簡易但卻極準確的檢驗,避免像其它核酸技術那樣需要進行繁瑣的樣品制備。
該檢驗產品由AdvanDX公司(Woburn, MA, USA; www.advandx.com)出品,已獲得美國食品藥品管理局(FDA; Silver Spring, MD, USA; www.fda.gov)的510(k)認證。它的問世使AdvanDx公司的易用型PNA FISH分子診斷平臺如虎添翼,快速的檢驗結果可以引導治療,使臨床醫生能盡早向革蘭氏陰性血流感染(BSI)患者提供有效治療。
GNR信號燈PNA FISH檢驗將使微生物實驗室能比傳統方法提前24-48小時識別并報告陽性血液培養物中的大腸桿菌、肺炎克氏桿菌和綠膿桿菌。如此快的結果將使臨床醫生占有先機,為革蘭氏陰性血流感染患者選用恰當而有效的療法,研究顯示這樣也許能改善臨床預后,減少不良事件的發生率,縮短住院時間。
AdvanDx is a leading provider of rapid and accurate molecular diagnostic tests for identification of pathogens causing critical infections in hospitalized patients. Our mission is to help healthcare providers optimize antibiotic therapy earlier in order to improve patient outcomes while limiting unnecessary antibiotic use and reducing hospital costs.
AdvanDx employs a unique, Whole Cell Analysis (WCA) approach to pathogen identification using our proprietary Peptide Nucleic Acid Fluorescence In Situ Hybridization (PNA FISH) technology platform. This technology enables fast and highly accurate single cell analysis for species, resistance and virulence marker identification of bacterial cells found in samples from patients with critical infections.
AdvanDx is the market leader in molecular testing of positive blood cultures enabling clinical microbiology labs to report pathogen identification results 48 to 72 hours earlier than with conventional testing methods. When used by physicians and pharmacists to ensure early, appropriate antibiotic therapy for patients with bloodstream infections (a.k.a. septicemia), AdvanDx’s PNA FISH? tests have been shown in clinical studies to reduce patient mortality, shorten length of stay (LOS) and lower hospital costs.