ReaMetrix India Pvt. Ltd., the next generation healthcare technology company has indigenously developed the first-ever immuno-diagnostic assay 'Accuford' Tri-T Stat reagent kit with a shelf life of 18 months to monitor CD4/CD8 T cells in HIV positive patients. The company has only imported raw material of the reagent from leading global gold standard suppliers.
The novel kit is an affordable diagnostic option for the 5.1 million HIV positive cases in the country that need to undergo tests frequently as a part of the physician disease management protocol. ReaMetrix is making available 'Accuford' Tri-T Stat reagent kits to the diagnostic laboratories at Rs. 150 and this would lead to a reduction in the cost of CD4/CD8 T cell tests from Rs. 2000 to Rs. 500.
It is estimated that only 10 per cent of the 5.1 million HIV positive cases have the financial means to test the effects of HART twice a year as per WHO protocol because it is more expensive than the drug therapy.
The kit, which includes a fluorescent labelled monoclonal antibody, is a gold standard FDA approved product which has undergone 200 tests performed on HIV positive cases at the Anand Laboratory in Bangalore and the Lister Laboratories in Chennai.
The seven-month kit development programme at the ReaMetrix facility set-up at an investment of $1.5 million in the Peenya Industrial Area in Bangalore is now awaiting clearances from the Karnataka Drugs Control Department for the production of these reagents.
Accuford (accurate + affordable), Tri-T Stat (measure 3 cells: CD4/CD8/CD3 and tell the status of T cells which control the immune system), can now provide the feedback to physicians on HART dosage regulation.
"We have taken advantage of the local economic paradigm in the country and not made any compromises on the quality by reducing the cost of the product,'' Dr. Bala S Manian, director, ReaMetrix India told Pharmabiz.
Globally the diagnostic industry is valued between $12-15 billion where the market size pf immunology based reagents including CD4/CD8 is between $300 and $400 million. In India, the diagnostic market is around $150 million where Becton Dickinson holds an 80 per cent share, Beckman Coulter has 15 per cent and 5 per cent is shared by other foreign players in the immunology segment.
For product distribution, ReaMatrix has teamed-up with Millipore India, the lab life sciences major, which makes a maiden entry into the diagnostic space to distribute the product via a cold chain beginning with New Delhi, Mumbai, Chennai and Hyderabad and then move on the other cities.
"Millipore has already hired ten sales personnel which include a manager and application support team," stated Sudhir Kant, president, Millipore India.
ReaMetrix has been a regular supplier of reagents for the pharmaceutical sector globally and for National Institute of Health, US for drug discovery and vaccine programmes.
For the future, ReaMetrix has four products in the pipeline. These include a viral load test with Tri T Stat reagent for which it has tied up with two research institutes in New Delhi and Bangalore.