Novel PPL-based chemistry platform and workflow for ultra-sensitive, low cost detection of gene targets

液体活组织检查的概念作为一种常规筛查方法有着巨大的前景，然而，目前的方法虽然适合用于分析组织活检，但远远不够敏感、特异或廉价，无法实现常规使用。目前的平台化学，如罗氏的Cobas平台，目前被认为是黄金标准，需要至少5%的血液中发现的DNA含有突变。这是有问题的，因为通常远低于1%，通常0.1%的血液中必须检测的DNA中将包含该等位基因。这个问题在很大程度上是由于背景基因组DNA的数量，这使得仅用几个DNA分子进行高度特异性的PCR测试是有问题的。我们开发了一种非常新的方法和化学平台，通过结合几个新的步骤，允许我们在基因组DNA的背景下只检测几个含有突变等位基因的DNA分子。这将使我们能够大大超过目前的检测极限，而不需要新的仪器、测序或数字聚合酶链式反应。“

"The concept of liquid biopsy holds tremendous promise as a method of routine screening, however current methods, although suitable for use in analysing tissue biopsies, are far from sensitive, specific, or inexpensive enough to enable routine use. Current platform chemistries, such as Roche's Cobas platform, currently considered the gold standard, require at least 5% of the DNA found in blood to contain a mutation. This is problematic as often much less than 1%, and frequently 0.1% of the DNA in blood that must be detected will contain this allele. Much of this problem is due to quantity of background genomic DNA present, and which makes highly specific PCR tests from only a few molecules of DNA problematic.We have developed a highly novel method and chemistry platform which, by combining several novel steps, allows us to detect only a few molecules of mutant allele-containing DNA against a background of genomic DNA. This will allow us to significantly exceed the current limits of detection without requiring novel apparatus, sequencing or digital PCR."