ImmunoSite Technologies Has Been Working With The “CD4 Initiative” To Develop Quality Assurance Materials For Novel, Disposable CD4 Test

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The CD4 Initiative at Imperial College, London, funded by Bill and Melinda Gates Foundation grants, is nearing a major breakthrough in HIV/AIDS care by developing a simple, inexpensive CD4 point-of-care test specifically designed for resource-poor settings. ImmunoSite Technologies has been developing QA materials for the innovative, disposable test kit.

"The ImmunoSite team is very honored to have been selected by the Imperial College of London and the CD4 Initiative to continue the development of the essential quality assurance materials for this assay." Wade Bolton, Ph.D.

Since early 2007, researchers from ImmunoSite Technologies (IST) have been working with a prestigious international group of medical researchers known as the CD4 Initiative to develop a CD4 cell count test that can be made inexpensively available to millions of HIV-positive people in resource-poor nations. The CD4 Initiative is headed by principal investigator Dr. Hans-Georg Batz, and managed by Dr. Steven Reid at the Imperial College, London. The Initiative was started in 2005 with an $8.6 million grant from the Bill & Melinda Gates Foundation, and received an additional $7.3 million in 2009 from the Foundation to support trials of the new test, the development of a manufacturing process and initial production runs. Now, after almost four years of aggressive R&D, the new test is about to go to field trials to ascertain its use in low-resource areas.

According to World Health Organization statistics, approximately 34.3 million people are living with HIV. The largest numbers of HIV-positive people are in Africa, Asia, India, South America and other developing nations where CD4 testing is needed to measure the status of the immune system and help determine if and when treatment should begin. Without available and accurate CD4 testing, many patients will not begin treatment until they are very sick and the effectiveness is greatly limited. Currently, most CD4 testing is done on complex and expensive flow cytometry instrument systems and requires many time-consuming, manual steps performed by a highly trained and experienced operator. The CD4 Initiative was established with the goal of making CD4 cell counting widely available to the millions of HIV patients in resource-poor nations, so that patients needing treatment can be easily identified, and the efficacy of treatment can be monitored.

The CD4 Initiative has pioneered a unique, multi-partner project management approach to developing an inexpensive point-of-care test. Many groups submitted proposals, and initially five companies were provided grants to develop a test. The CD4 Initiative brought scientific researchers from academia together with researchers from private companies and other institutions, forming a collaborative yet competitive approach between test groups. At critical points in the development, independent evaluators assessed the test prototypes from each group in order to identify the group whose test best met the required standards to be awarded funds to develop their test.

Of these competing groups, researchers at ImmunoSite Technologies have been selected for grant awards since early 2007. In late 2009, they were awarded continued funding by the CD4 Initiative to further develop quality assurance (QA) material for the test, and Zyomyx Inc., a California company, was awarded continued funding to develop a simple, non-electronic, point-of-care device. The QA material will ensure that the test device provides results that are accurate and precise.

Principal investigator on the CD4 Initiative project at ImmunoSite Technologies is Sybil D’Costa, Ph.D., VP of research and development. “The main challenge for our team has been to develop a cell-based, quality assurance reagent that mimics the properties of CD4 T cells in whole blood, and will operate properly and consistently in elevated temperatures, such as those common in sub-Saharan Africa and similar countries,” said Dr. D’Costa. The IST team has successfully developed QA material that works well with the test device, and is continuing to test performance as they move into production.

Key to the success of the IST team is their extensive expertise in cellular analysis, cellular quality control material development, and assay development. Dr. D’Costa has worked together with Wade Bolton, Ph.D., president and CEO of IST, for almost 10 years developing assays for immune system monitoring and surveillance. Both previously worked together in the Custom Biopharma Solutions division at Beckman Coulter Inc., a world leader in clinical diagnostics, developing innovative cellular analysis products and reagent systems.

Next steps for ImmunoSite Technologies on this project: complete R&D evaluation of elevated temperature stability of the QA material, develop Good Manufacturing Practice (GMP) manufacturing processes to meet the high demand, and conduct activities required to obtain regulatory approval of the product for distribution and use in resource-limited settings.

“The ImmunoSite team is very honored to have been selected by the Imperial College, London and the CD4 Initiative to continue the development of the essential quality assurance materials for this assay”, said Dr. Bolton. The team is strongly motivated by the serious facts of the HIV crisis. An estimated 33 million people worldwide are living with HIV. Sub-Saharan Africa bears a disproportionate burden of the global epidemic with 67% of the all HIV cases and 72% of AIDS-related deaths in 2009 (World Health Organization statistics). The ability to decentralize HIV diagnosis and monitoring from centralized hospitals to widespread rural settings will be critical in the management of the epidemic. In order for this to happen, health care workers must have simple yet robust CD4 tests and accompanying QA materials.

About ImmunoSite Technologies

Based in Ft. Lauderdale, FL, ImmunoSite Technologies, LLC (IST) offers a full range of contract research (CRO) immune monitoring services to leading biotechnology, pharmaceutical, and academic organizations around the world to provide products and services that span all stages of drug discovery and development. The company is uniquely qualified to develop assays and conduct testing to assess immune status and function. IST is rapidly building a worldwide reputation for services related to qualifying, standardizing, and when appropriate, automating assays associated with cell-mediated immunity. IST services include flow cytometry, particle characterization, application development, automation, assay development and testing. By using qualified reagents, controls, standards and processes, IST-developed functional assays perform within tight specifications and yield reproducible results, helping pharmaceutical and biotechnology companies to accelerate drug discovery, document clinical relevance and reduce costs.

A privately held company, IST was formed in August, 2009, to bring together a highly qualified team of industry leading immune system research and development scientists who together have more than 100 years of experience developing and performing assays related to immune monitoring and surveillance. The IST team has been distinguished by their ongoing partnerships with best-in-class clinical trial organizations such as: the Immune Tolerance Network, the Immune Tolerance Institute, and the Imperial College of London managed CD4 Initiative. This extensive cell analysis R&D experience qualifies IST scientists to comply with complex and demanding international scientific and governmental regulations.


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