Development of a platform for point-of care testing: Accelerating the Assay Pipeline

Evik Diagnostics建议与麦克马斯特大学的Sandeep Raha博士合作，验证和转移快速分析开发技术，这将有助于公司加速新的诊断测试推向市场。在IRAP的帮助下，Evik开发了简单、低成本的一次性药筒测试，所有试剂都是封闭的，适合在非洲和其他资源有限的环境中部署。它们在简单和稳定方面类似于家用验孕棒。这种检测设备的第一个市场目标是日益严重的艾滋病毒/艾滋病流行病。尽管经过了30年的发展努力，我们仍然没有研制出艾滋病毒疫苗。全世界有3400万艾滋病患者，每年有250万新病例报告。对这种检测设备的需求是巨大的，数亿人需要筛查新的感染，接受抗逆转录病毒治疗的人需要反复监测病毒载量。该测试设备将通过HIV p24浓度和血液中的p24抗体来报告病毒载量，这种组合方法已被证实比DNA测试更快、更简单，但灵敏度较低。使用微阵列高通量筛选，Raha博士的实验室将测试抗体库，以找到最高HIV检测灵敏度的最佳配对，并为测试设备提供标记的抗体偶联物。Raha博士的实验室将把微阵列和共轭化学技术转让给Evik，并将这些快速分析开发工具交给公司，以便Evik能够快速将后续诊断测试推向市场。这种互补技术的联盟也将促进未来其他诊断分析的发展，并促进加拿大生物技术产业。

Evik Diagnostics proposes to engage with Dr. Sandeep Raha, McMaster University, to validate and transfer rapid assay development technologies that will help the company to accelerate new diagnostic tests to market. With assistance from IRAP, Evik has developed simple, low cost, disposable cartridge tests, with all reagents enclosed, that are suitable for deployment in Africa and other resource limited settings. They are similar to a home pregnancy test in simplicity and stability. The first market target for this test device is the growing HIV/AIDS pandemic. Despite 30 years of development effort we do not yet have an HIV vaccine. Worldwide, 34 million are living with AIDS, and 2.5 million new cases are reported each year. The demand for this test device is enormous with hundreds of millions needing screening for new infection, and people living with retroviral therapy needing repeated monitoring for viral load. The test device will report viral load by HIV p24 concentration plus p24 antibodies in blood, a combination method which has been validated to be faster and simpler than DNA tests but in sensitivity. Using microarray high throughput screening, Dr. Raha's lab will test a library of antibodies to find the optimal pair for highest HIV detection sensitivity, and will provide labeled antibody conjugates for the test device. Dr. Raha's lab will transfer the microarray and conjugate chemistry technologies to Evik and vest these rapid assy development tools in the company so that Evik can quickly bring followup diagnostic tests to market. This alliance of complementary technologies will also foster the development of additional diagnostic assays in the future and promote the Canadian Biotechnology industry.