Rapid, Inexpensive Microchip Assay for Homocysteine

描述(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。这种疾病的治疗每年花费数十亿美元，而且成本继续呈指数级增长。如果被认为是心血管疾病之外的一种单独的疾病，中风是继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的独立危险因素。此外，它是叶酸和Colalamin(维生素B12)缺乏的敏感标志，与出生缺陷、妊娠并发症、精神障碍和老年人的认知障碍有关。在美国，每年有数百万次与这些疾病相关的tHCY测试。THCY作为心血管疾病的一个可改变的危险因素已经引起了人们的极大关注，因为只需通过饮食补充叶酸和维生素B12就可以降低水平。虽然tHCY在这种方式上的价值仍未得到证实，但越来越多的有力证据表明，它与中风特别相关。与此同时，tHCY作为服用已知可降低叶酸代谢的药物的患者的维生素缺乏症监测工具，正在找到一个不断增长的市场。另一种标记，还原同型半胱氨酸(ReHCY)，也被提出作为tHCY的替代。目前，tHCY和reHCY分析需要昂贵的仪器和耗时的程序，并且只能在临床实验室进行。先进的微型实验室，有限责任公司正在开发用于快速检测疾病生物标志物的微流控技术，这种技术将是廉价的(仪器500美元，每个化验3美元)，需要非常小的样本(即手指刺伤而不是抽血)，在几分钟内就能提供结果，并且不需要像现在这样的样本前处理，如离心法。在目前的项目中，我们将在我们成功的第一阶段结果的基础上，创建一种用于检测tHCY和reHCY的多功能护理点设备。此外，由于我们的设备是一个多分析物平台，其他相关标记可以在第三阶段添加到我们的菜单中。 与公共健康相关：美国PoC市场在2005年成为一个价值100亿美元的行业，目前的增长速度快于中央实验室检测。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，并增强了医生和患者的对话，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.