ReaMetrix India Pvt. Ltd., a leading healthcare technology company has received the approval from the Karnataka drugs control department to manufacture and market 'Accuford' Tri-T Stat reagent kit, the latest drug therapy-monitoring assay for HIV cases. The company has now started manufacture and marketing the product.
The product is used to monitor the progress of treatment for HIV positive patients. It is used to tests the count of CD4/CD8 T cells which determines the progression of the disease.
The indigenously developed kit was the research efforts of ReaMetrix chief Dr. Bala S Manian, who managed to successfully produce the product with an antibody which was imported for the assay from global suppliers. The reagent was developed at its facility in Bangalore. The fluorescent labelled monoclonal antibody is on par with gold standard FDA, approved products of Becton Dickinson and Beckman Coulter.
The development of the kit spanned over a period of seven months and late last year 2005 it was submitted to the regulatory authorities. Now the approval from the State drugs control department allows the company to work out its future plan of action, informed company sources.
As per the WHO protocol at least a minimum of two tests of CD4 and CD8 T Cells are to be performed to ascertain the efficacy of the drug therapy and this was becoming unaffordable as the diagnostic charges were more expensive than the actual drug therapy. 'Accuford' Tri-T Stat reagent kit can bring down the cost from Rs. 500 to Rs. 150 which is a fourth of the imported unit cost for 50 tests.
In India only 10 per cent of the 5.1 HIV positive cases are able to afford the test to detect the high dose of anti retroviral therapy (HART) in their immune system. Now with 'Accuford' Tri-T Stat reagent kit which has already undergone extensive tests on patients at the Anand Laboratory in Bangalore and the Lister Laboratories in Chennai will provide a big relief in the HIV treatment programmes.
The company is located next to Millipore India at the Peenya Industrial Estate in the outskirts of Bangalore. Although, the company had initially depended on Millipore to market the product going by its expertise in the lab equipment space, the latter had to keep away because it was moving away from its corporate focus. Now ReaMetrix has armed its self to market the product on its own.
In the Indian reagent kit market for the therapy has Becton Dickinson holding 80 per cent of the share while Coulter holds 15 per cent and the balance is held by small- sized foreign players.
The manufacture and research unit of ReaMetrix in Bangalore was set up at an investment of $1.5 million. Among the future products from the company include a viral load test with Tri T Stat reagent and an infectious screen to detect 6 different diseases in one blood sample, tests for auto immune disorders.