Espicom View : Atomo Diagnostics is entering a market that has an unmet medical need. The high rates of HIV in South Africa make it an ideal market to launch its point-of-care diagnostic in. Accuracy, storage and the fact that the test is self contained will benefit the company. These factors will also provide entry into markets that do not have access to facilities that can store and refrigerate reagents needed for other point-of-care tests. However, devices that could outperform AtomoRapid HIV are in development, although it could be a while before these make it to market.
Atomo Diagnostics is launching AtomoRapid HIV, an all in one rapid HIV test that significantly improves ease of use and the reliability of rapid HIV testing in the field. The AtomoRapid HIV test is believed to be a lot simpler to perform than currently used tests, and removes the need for manual steps requiring extensive skill and clinical training. In doing this, AtomoRapid HIV removes the source of many errors common with current generation test kit-based procedures.
A large South African study proved that the actual sensitivity of HIV test kits used outside of the laboratory was on average 93.5 per cent and even with additional training and quality control improvement increased to only 95.1 per cent. Across Africa, this potentially results in several hundred thousand people being misdiagnosed with HIV every year. Understandably, the effect of misdiagnosing a person who is HIV-positive could result in increased transmission. AtomoRapid's is claimed to have 99.8 per cent sensitivity and 99.7 per cent accuracy, an improvement on the currently available tests.
To ensure superior performance, the AtomoRapid HIV product uses a proven HIV test strip that has been World Health Organization (WHO) pre-qualified and sold in the market for many years. Atomo now delivers this test in the field as a next-generation solution specifically designed to meet users' needs and reduce misdiagnosis. AtomoRapid HIV will be available to customers in the coming months of 2013.
According to the WHO, Africa has the highest prevalence of HIV/AIDS, with a rate of 23 million in 2011. Approximately 69 per cent of people living with HIV are located in the sub-Saharan Africa region. In South Africa alone there is an HIV prevalence rate of 11,087 per 100,000 population. The population living with HIV is expected to grow as treatment regimens improve. Diagnosis will be key in ensuring that the prevalence of HIV does not increase.
According to the Centers for Disease Control and Prevention there are currently 25 PoC test for HIV available. Most of these are not as quick as the Atomo device and require the use of separate agents. As a self contained device, there are benefits to AtomoRapid HIV. However, Chembio Diagnostics has a similar device that is FDA approved but not yet available in South Africa. In December 2012, Chembio received FDA approval to market its Dual Path Platform (DPP) HIV 1/2 assay for the rapid, PoC detection of HIV-1/2 antibodies in either oral fluid or blood samples. Chembio's DPP PoC HIV 1/2 assay detects antibodies to HIV 1 and HIV 2 in oral fluid, fingerstick whole blood, venous whole blood, serum or plasma samples, and provides a simple "reactive/non-reactive" result. DPP HIV 1/2 delivers visual results within 15 minutes, is simple to use, requires minimal sample size, has a shelf life of 24 months and does not require refrigeration. A proprietary sample collection system enables each sample to be contained in a convenient, closed collection vial (a Sampletainer), which may provide additional sample for repeat testing, allowing greater testing flexibility over other systems that do not have separate sample collection or that use open vials for stirring blood samples. If Chembio does make it to the South African market, it has similar features to the Atomo device, which features a similar shelf life as the Chembio device, it could be a matter of marketing presence that determines the market leader.
Other PoC tests for HIV are in development. OJ-Bio recently received funding for its PoC HIV test based on its sensor technology with specific HIV coatings. The use of a biochip in this device rather than reagents will give OJ-Bio a competitive edge. PoC tests will be useful in detecting the disease but ultimately, laboratory diagnostics will be needed to determine immunological and virological factors of HIV.