美国Rules-Based Medicine (RBM)
“在98年，所有人都处于基因分型的歇斯底里中。我们曾经以为世界上所有的问题都将通过Craig Venter的DNA测序来解决，结果那也只是过客，并没有解决重要的问题。” Rules Based Medicine （RBM）的策略研发执行官Ralph McDade博士说道，该公司是位于美国奥斯丁市的一家生物标志物检测实验室。McDade补充道：“现在，人们突然认识到，血液中的效应分子——蛋白质是疾病的一些最早期信号。”将上述蛋白质模式转变为可实践的诊断测试是该领域的最新关注焦点，虽然该策略仍然面临着较大的障碍，但是专家们都乐观的认为癌症生物标记物终于找到了正确的发展方向。

星火燎原

RBM从概念性的简单策略起步：使Luminex免疫检测可以自动化和多重化的进行生物标记物追踪，RBM与Luminex由同一伙人成立。Luminex技术使用包被了抗体的染色微珠来检测方案中的特定抗原。通过在单次检测中组合不同的微珠，RBM可以监控多组蛋白质随时间的改变。

例如，公司的HumanMAP抗原产品，现在可以定量血清样品中89种不同抗原的水平，从脂联素到维勒布兰德（Willebrand）因子。McDade 表示：“在不远的将来，我们将讨论在几百个血清或血浆的微滴度板上进行1,000组定量的免疫检测。”

目前，RBM正实施上述检测服务基础生物医学研究和临床药物实验，但是，来自美国国立癌症研究所（NCI）的110万美元的资助将帮助该策略转用于诊断用途。在该笔资助下，公司将拓展HumanMAP系统，最初将增加由NCI研究人员发现的50种新的癌症生物标记物。

项目的第二波将进一步扩大。McDade 表示：“我们了解到此后的研究管道中还存在1,050种以上的生物标记物。这是一个巨大的合作项目，它将建立起在不同的癌症类型中强烈上调或下调的1,100种不同蛋白质的抗原和抗体。”

在另一项工作中，该公司将帮助检测一组卵巢癌的新标志物。McDade表示：“我们将进行诊断的多位点临床实验，相信将对II期卵巢癌产生约85%的灵敏度和特异性。”II期癌症涉及一侧或双侧卵巢，以及骨盆中的相邻器官。如果能在该时间点检测出癌症，则五年存活率可以超过75%；随着疾病进一步发展，存活率将显著下降。

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