Rapid, Inexpensive Microchip Assay for Homocysteine

描述（由申请人提供）：心血管疾病（CVD）是美国和西方世界大部分地区的头号杀手。治疗这种疾病每年花费数十亿美元，而且费用继续呈指数级增长。如果被认为是CVD之外的一种独立疾病，中风是心脏病和癌症之后的第三大死亡原因。总同型半胱氨酸（tHCY）是CVD的一个独立危险因素。此外，它是叶酸和维生素B12缺乏症的敏感标志物，与出生缺陷、妊娠并发症、精神疾病和老年人认知障碍有关。在美国，每年进行数百万次与这些条件相关的tHCY测试。tHCY作为心血管疾病的可改变风险因素已经引起了极大的关注，因为可以通过膳食补充叶酸和维生素B12来降低水平。虽然tHCY在这种方式中的价值仍然没有得到证实，但强有力的证据正在增加，特别是与中风有关。与此同时，tHCY作为维生素缺乏症监测工具，正在寻找一个不断增长的市场，用于服用已知会降低叶酸代谢的药物的患者。另一种标记物，还原型同型半胱氨酸（reHCY），也被提议作为tHCY的替代品。目前，tHCY和reHCY分析需要昂贵的仪器、耗时的程序，并且只能在临床实验室中进行。Advanced Microlabs，LLC正在开发用于快速检测疾病生物标志物的微流体技术，该技术将是廉价的（500美元的仪器，3美元/测定），需要非常小的样品（即，用手指刺破而不是抽血），在几分钟内提供结果，并且不需要样品预处理，如目前的情况下的离心。在目前的项目中，我们将建立在我们成功的第一阶段结果的基础上，并创建一个用于检测tHCY和reHCY的多功能床旁设备。此外，由于我们的设备是一个多分析物平台，其他相关标志物可以添加到我们的菜单在第三阶段。 公共卫生相关性：美国POC市场在2005年成为一个价值100亿美元的行业，目前的增长速度超过了中心实验室检测。这是因为像我们这样的设备提供了更便宜的测试，更接近患者，降低了医疗成本，并增强了医患对话，从而改善了护理。

DESCRIPTION (provided by applicant): Cardiovascular disease (CVD) is the number 1 killer in the United States and much of the Western world. Treatment of the disease costs billions of dollars each year and the costs continue to rise exponentially. If considered as a separate condition outside of CVD, stroke is the 3rd leading cause of death behind heart disease and cancer. Total Homocysteine (tHCY) is a confirmed independent risk factor for CVD. Additionally, it is a sensitive marker for folate and colalamin (vitamin B12) deficiency, with implications to birth defects, pregnancy complications, psychiatric disorders, and cognitive impairment in the elderly. Several million tHCY tests are performed annually in the U.S. related to these conditions. tHCY has garnered significant attention as a modifiable risk factor for CVD because levels can be reduced simply through dietary supplementation of Folic Acid and Vitamin B12. While tHCY's value in this manner still remains unconfirmed, strong evidence is mounting in its association specifically with stroke. At the same time, tHCY is finding a growing market as a vitamin deficiency monitoring tool for patients taking drugs known to degrade folate metabolism. An additional marker, Reduced Homocysteine (reHCY), has also been proposed as an alternative to tHCY. Currently, tHCY and reHCY analysis requires expensive instrumentation, time consuming procedures, and can only be performed in a clinical laboratory. Advanced Microlabs, LLC is developing microfluidic technology for rapid detection of disease biomarkers that will be inexpensive ($500 instrument, $3/assay), require very small samples (i.e., finger prick instead of a blood draw), provide results within minutes, and require no sample pretreatment such as centrifugation as is now currently the case. In the current project, we will build on our successful Phase I results and create a versatile point-of-care device for the detection of tHCY and reHCY. Additionally because our device is a multi-analyte platform, other relevant markers could be added to our menu in Phase III. PUBLIC HEALTH RELEVANCE: The U.S. POC market became a $10 billion industry in 2005 and is currently growing at a faster rate than central laboratory testing. This is because devices like ours offer cheaper testing, closer to the patient, reduction in healthcare costs, and enhancements the physician-patient dialog and thus improving care.