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

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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.