Based on its recent analysis of the HIV monitoring diagnostics market, Frost & Sullivan recognizes Zyomyx with the 2010 North American Frost & Sullivan Technology Innovation Award for its path-breaking point of care (POC) device for CD4 counting in HIV patients.
HIV infections dampen the immune system and lead to destruction of CD4 cells. Thus, measuring the CD4 lymphocytes is an indirect measure of the HIV infection and provides a good parameter for quantifying the extent of infection and monitoring patients who are on antiretroviral therapy (ART). Unlike flow cytometry, the existing gold standard for CD4 testing, which is complicated, expensive, and needs trained staff, Zyomyx's device uses a patented cell stacking assay technology to give an accurate count of CD4 cells in the blood. It is a rapid, sensitive, instrumentation-free test that provides results in about 10 minutes.
The test is reproducible and has advantages over lab-on-chip tests in terms of costs, test complexity and accuracy. It is also the first test that requires no electronics, failure-prone optics and fluidics, stains, or expensive reagents, and still delivers the same results as a flow cytometer or an electronic based readout.
"Since the prevalence of HIV is very high in many economically deficient countries, POC tests for HIV monitoring will allow decentralization of testing and help obtain early ART, drastically reducing healthcare costs," said Frost & Sullivan Research Analyst Ruplekha Choudhurie. "Zyomyx's affordable and easy to perform CD4 test will, thus, have a huge impact for people living with HIV across the world and will allow HIV/AIDS surveillance for the millions of patients who normally would not have access to such tests."
Zyomyx's device is like a thermometer and the number of CD4 cells can be directly read off with the naked eye. This prototype has been validated in multiple 3rd party evaluations and is poised to enter field trials. The test is simple, robust, and user friendly, and is expected to meet performance standards of existing CD4 counting technologies.
The Zyomyx CD4 test will be Conformité Européene marked and subsequently also obtain Food and Drug Administration (FDA) 510(k) clearance. It has the potential to provide a sustainable business for the company as the quantity of deliverable tests will likely be very high.
"Significantly, Zyomyx's proprietary technology can find applications in many cell-based diagnostic tests like differential cell count, tumor cell sorting, and other cell sorting assays," said Ruplekha. "It can suitably replace many of the laboratory-based tests, which are more expensive, require trained personnel, and can sometimes be erroneous."
For now, the Zyomyx POC technology is poised to revolutionize HIV/AIDS care and will provide clinicians and patients a facility for accurate testing. Since CD4 testing is an area with a huge unmet need, the commercialization of this kind of POC test will have a great impact on the HIV diagnostics industry. The potential market for these tests would primarily be impoverished countries where affordable diagnostics are not currently available.
Based on the level of innovation and the potential it holds, Zyomyx is the recipient of the 2010 North American Frost & Sullivan Award for Technology Innovation in the POC CD4 tests market for HIV monitoring.
"We are honored to be recognized by Frost & Sullivan for our Point-of-Care CD4 test ", said Peter Wagner, Zyomyx' President and CEO. "Zyomyx is committed to bringing this important test to the global HIV community and this award is an indicator for the wide array of user benefits this product configuration will provide.
Each year, Frost & Sullivan presents this award to the company that demonstrates uniqueness in developing a technology, which significantly impacts both the functionality and the customer value of new products and applications. The award lauds the relevance of the innovation to the industry.
Frost & Sullivan's Best Practices Awards recognize companies in a variety of regional and global markets for demonstrating outstanding achievement and superior performance in areas such as leadership, technological innovation, customer service and strategic product development. Industry analysts compare market participants and measure performance through in-depth interviews, analysis and extensive secondary research to identify best practices in the industry.
Zyomyx, Inc., a privately held diagnostics company based in Hayward, California, is an innovator in the development and commercialization of proprietary diagnostic platforms. The Zyomyx product development infrastructure and suite of proprietary assay and surface technologies are ideally suited for the development of point-of-care diagnostic products. Zyomyx's immediate focus is an advanced, but simple and inexpensive CD4 T-cell point-of-care test that will be launched globally and configured to especially meet the demanding specifications for use in developing countries.
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