ReaMetrix India Pvt Ltd, a medical diagnostics company has launched "Dry Tri-T Stat" used in HIV management, for the global market. It is the only US FDA (FDA 510(K)) cleared dried-down CD4 enumeration product available globally for the flow cytometry instrumentation market.
The unitized, dried-down delivery format eliminates the need for refrigeration, exhibits nearly 99 per cent correlation with conventional liquid format and is at least three times more affordable than other products existing in the market.
The Bangalore-based company has a team of engineers, chemists, biologists and doctors who are developing innovative solutions in diagnostics.
The "dried-down" innovation is a successful validation of our thinking, as this is an innovation that is set to have a global impact, stated Dr. Bala Manian, CEO, ReaMetrix.
According to 2008 estimates, national adult HIV prevalence in India is approximately 0.36 per cent of total population, which is around 2.5 million people. Currently, there are 197 government Antiretroviral Therapy (ART) centres and some private ART clinics, spread across India where CD4 testing is available. Access to reliable, accurate and affordable CD4 testing solutions, is key in the clinical management of HIV patients.
Some of the predominant issues with CD4 testing in the Indian context are the high cost of testing, poor access to testing, poorly developed cold chain for the transport, storage and use of products and a complicated work flow, requiring skilled labour. The real challenge lies in transporting blood samples from remote areas to centralized testing centres. In most cases, this leads to "aged" blood samples making it unusable for testing, stated Dr. Manian.
ReaMetrix's innovative dried-down CD4 enumeration product helps address this need. With the unitized, dried down products, the cost of the CD4 enumeration test per patient will see nearly a four-fold reduction in costs, while, at the same time, producing accurate diagnosis. Blood can be collected, stained and fixed at the point of collection before being shipped to a central testing facility at room temperature. The stained samples can be stored for up to 7 days at room temperate eliminating the issue of "aged" blood samples.
Some of the key features of Dry Tri-T Stat are the decentralization of sample collection which helps collection at a remote centre before shipment to a central laboratory, processed Sample Stability, no refrigeration capabilities needed at point of blood collection, simplified workflow and affordability.
Announcing the availability of the FDA cleared HIV Management product, Dr. Anand Sivaraman, Product Evangelist, ReaMetrix India, said that the pre-dispensed product tubes enable a simplified workflow, assuring highest accuracy and reliability. The test is being made available at less than one-third of the cost of the existing, imported liquid-format reagent products.
Using ReaMetrix HIV dried-down products, doctors derive quality diagnostic information at an affordable price. This translates to lower cost of testing for the patient. Since there is no need for cold chain for use of these products, diagnostic laboratories are able to access samples from far-off locations, enabling better cost efficiencies on their centralized, capital-intensive equipments. From a public-health perspective, affordability enables frequent testing which in turn enables a doctor to take treatment decisions based on trends rather than on just a single test result.
The ReaMetrix portfolio of products currently includes products for monitoring HIV progression, stem cell enumeration, screening patients for ankylosing spondylosis, and staging cancer patients.