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美國Rules-Based Medicine (RBM)
“在98年，所有人都處于基因分型的歇斯底里中。我們曾經(jīng)以為世界上所有的問題都將通過Craig Venter的DNA測序來解決，結(jié)果那也只是過客，并沒有解決重要的問題。” Rules Based Medicine （RBM）的策略研發(fā)執(zhí)行官Ralph McDade博士說道，該公司是位于美國奧斯丁市的一家生物標(biāo)志物檢測實驗室。McDade補充道：“現(xiàn)在，人們突然認(rèn)識到，血液中的效應(yīng)分子——蛋白質(zhì)是疾病的一些最早期信號。”將上述蛋白質(zhì)模式轉(zhuǎn)變?yōu)榭蓪嵺`的診斷測試是該領(lǐng)域的最新關(guān)注焦點，雖然該策略仍然面臨著較大的障礙，但是專家們都樂觀的認(rèn)為癌癥生物標(biāo)記物終于找到了正確的發(fā)展方向。

星火燎原

RBM從概念性的簡單策略起步：使Luminex免疫檢測可以自動化和多重化的進(jìn)行生物標(biāo)記物追蹤，RBM與Luminex由同一伙人成立。Luminex技術(shù)使用包被了抗體的染色微珠來檢測方案中的特定抗原。通過在單次檢測中組合不同的微珠，RBM可以監(jiān)控多組蛋白質(zhì)隨時間的改變。

例如，公司的HumanMAP抗原產(chǎn)品，現(xiàn)在可以定量血清樣品中89種不同抗原的水平，從脂聯(lián)素到維勒布蘭德（Willebrand）因子。McDade 表示：“在不遠(yuǎn)的將來，我們將討論在幾百個血清或血漿的微滴度板上進(jìn)行1,000組定量的免疫檢測。”

目前，RBM正實施上述檢測服務(wù)基礎(chǔ)生物醫(yī)學(xué)研究和臨床藥物實驗，但是，來自美國國立癌癥研究所（NCI）的110萬美元的資助將幫助該策略轉(zhuǎn)用于診斷用途。在該筆資助下，公司將拓展HumanMAP系統(tǒng)，最初將增加由NCI研究人員發(fā)現(xiàn)的50種新的癌癥生物標(biāo)記物。

項目的第二波將進(jìn)一步擴大。McDade 表示：“我們了解到此后的研究管道中還存在1,050種以上的生物標(biāo)記物。這是一個巨大的合作項目，它將建立起在不同的癌癥類型中強烈上調(diào)或下調(diào)的1,100種不同蛋白質(zhì)的抗原和抗體。”

在另一項工作中，該公司將幫助檢測一組卵巢癌的新標(biāo)志物。McDade表示：“我們將進(jìn)行診斷的多位點臨床實驗，相信將對II期卵巢癌產(chǎn)生約85%的靈敏度和特異性。”II期癌癥涉及一側(cè)或雙側(cè)卵巢，以及骨盆中的相鄰器官。如果能在該時間點檢測出癌癥，則五年存活率可以超過75%；隨著疾病進(jìn)一步發(fā)展，存活率將顯著下降。

Rules-Based Medicine (RBM), the world’s leading multiplexed biomarker testing laboratory, provides comprehensive protein biomarker products and services based on its Multi-Analyte Profiling (MAP) technology platform. RBM’s biomarker testing service provides pre-clinical and clinical researchers with reproducible, quantitative, multiplexed immunoassay data for hundreds of proteins in a cost-effective manner, from a small sample volume and from multiple species. Our biomarker testing laboratory is CLIA certified and supports GLP studies.

Most diseases and drug effects manifest themselves in abnormal levels of specific biomarkers found in the peripheral blood. By providing multiplexed, quantitative, and reproducible tests for hundreds of biomarkers, RBM enables research that historically was not available due to sample volume requirements and associated costs. Use of our testing services can identify the sources of both the positive and negative effects of drugs during pre-clinical research and clinical trials. Biomarker testing results identify patients most likely to respond to a given therapy and the biochemical reason for that response, making clinical trials more successful and effective.

Through its wholly owned subsidiary EDI GmbH, RBM provides Human Organo-Typic (HOT) cell culture systems. These co-culture systems consist of multiple primary cell types grown in a 3-D architecture that closely mimic particular human organs and are an ideal platform for ex vivo studies of drug safety and efficacy. RBM combines EDI’s cell culture systems with its HumanMAP? biomarker testing services to provide researchers with an unprecedented view of the physiological and biochemical impact of a new drug compound or consumer product prior to testing in a human subject.

RBM also performs custom assay development, participates in co-sponsored research programs, and pursues in-licensing of novel high-value assays.

RBM employs over 90 people at three facilities:

Austin, TX: Corporate headquarters and CLIA-certified biomarker testing laboratory
Lake Placid, NY: Multiplex assay development and manufacturing
Reutlingen, Germany: HOT cell culture services