DIGITAL SINGLE-USE FREE AND TOTAL PSA RAPID TEST

前列腺癌在美国每年造成约4万人死亡 是男性癌症死亡的第二大原因。每年， 这种疾病的新病例超过30万例。诊断的一个关键目标 癌症的关键是及早发现，这使医生能够在 肿瘤生长处于早期阶段的时间。一种快速而廉价的 前列腺癌生化测试(由Metrika‘s设备提供)， 配合直肠指诊，将大大有助于 医生在病人还在的情况下提供诊断 办公室，并能就治疗效果提供及时的反馈 以及对复发的检测。测量自由空间和总空间 前列腺特异性抗原(PSA)水平将有助于区分 良性前列腺增生症(BPH)所致的恶性肿瘤。 Metrika实验室将开发数字响应自由/总PSA 快速检测是一种快速、一次性使用的检测方法，它基于 同时测定血清、血浆或血清中两类PSA 全血样本，以产生定量的数值结果。这个测试 大约一张信用卡大小的设备将结合在一起 廉价的微电子学和干试剂免疫化学。焦点 这项建议的重点是论证干试剂的可行性 免疫分析及其集成到面包板设备中。 这种创新的测试将是廉价的，操作极其简单， 将在几分钟内提供结果的数字显示。这 技术将通过改善医疗保健系统使医生和医疗保健系统受益 医疗点的医疗服务效率。此外, 患者将不会回访办公室，这需要损失时间。 从工作和其他费用，并将收到他们的即时反馈 关于这种高度流行的癌症的状况。 建议的商业应用： 数字响应免费/总PSA快速测试在关怀点站点 可获得快速定量分析的机会有限或根本不存在。 泌尿科医生和初级保健医生将启动和控制使用 这项测试将产生显著的经济效益和患者效益。

Prostate cancer causes about 40,000 deaths per year in the United States and is the second highest cause of cancer death among males. Each year, there are over 300,000 new cases of this disease. A key goal in diagnosis of cancer is early detection which allows physicians to intervene at a time when tumor growth is at an early stage. A rapid and inexpensive biochemical test for prostate cancer (provided by Metrika's device), in conjunction with digital rectal examination, will greatly assist the physician in providing a diagnosis while the patient is still in the office, and can provide timely feedback on the effectiveness of treatment and on the detection of recurrence. Measurement of both free and total levels of prostate specific antigen (PSA) will help to distinguish malignancy from benign prostatic hyperplasia (BPH). Metrika laboratories will develop the Digital Response Free/Total PSA Rapid Test which is a rapid, single-use, disposable assay based on the simultaneous measurement of both classes of PSA in a serum, plasma or whole blood sample to yield quantitative numerical results. The test device, which will be about the size of a credit card, will combine inexpensive microelectronics and dry reagent immunochemistry. The focus of this proposal is on demonstrating the feasibility of the dry reagent immunoassays and their integration into a breadboard device. This innovative test will be inexpensive, extremely simple to operate and will provide a digital display of results in a few minutes. This technology will benefit physicians and the healthcare system by improving the efficiency of healthcare delivery at the point of care. In addition, patients will not be subject to return office visits, requiring lost time from work and other expenses, and will receive immediate feedback on their status with respect to this highly prevalent form of cancer. PROPOSED COMMERCIAL APPLICATION: The commercial applications of the Digital Response Free/Total PSA Rapid Test are in point of care sites where access to a rapid quantitative analysis is limited or non-existent. Urologists and primary care physicians will initiate and control use of the test which will yield significant economic and patient benefits.