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Agappe’s hematology analyzer MISPA Count-X, a matter of pride in Atmanirbhar Bharat 2021

The importance of basic hematology parameters in diagnostics and healthcare is so well established over the last 100+ years, that it does not need to be emphasized in 2021. Today, In India, millions of tests are carried out daily on fully automated hematology analyzers and it is practically unimaginable that a diagnostic lab India is without an automated hematology analyzer.

Nevertheless, it would not be out of place to look at the path we walked to reach here. In times of 4G tele spectrum which soon move on to 5G, it could be said that changes in hematology analysis have come about over 2 generation of diagnosticians and nearly 6 generations of analyzers.

I nostalgically recall my first semi-automated cell counter, acquired in early 1979-80. It was imported, could measure only Hgb, RBC & WBC, equipment cost about Rs. 30,000 and about Rs. 5 per sample. The imported reagents came with a whopping 150 percent tax on import costs and, due to uncertainty of imports, prodded users like me to even prepare reagents in-house. With the economic liberalization of the early 1990s, fully automated hematology analyzers appeared on scene. These could generate 18 hematology parameters – including a 3-part WBC differential – in just a minute. These so called 3-PDA analyzers were also imported from abroad at the capital cost of about Rs. 5,00,000, and running them cost Rs. 10 per sample. These stiff costs were the major hurdle and blocked benefits of automated hematology analysis from reaching vast majority of Indian patients. However, with the increasing demand from users and sustained efforts by in vitro diagnostic (IVD) industry to meet it, began yielding fruits. Now, users had choice of analyzer options, learned the pros-cons of features offered by them and, as the scale of economies tilted in users’ favour, the benefits of automated analysis came close to larger segment of Indian patients.

Indigenization process that began in the late 1990s with local manufacturing of reagents and consumables, brought the operative costs of automated hematology analysis closer to levels permitting their deeper penetration into tier 2, 3 cities and towns. However, International IVD manufacturers who had already begun noticing the rapidly increasing installations, somehow, still shied away from establishing facilities to manufacture hematology analyzers in India.

Taking a strong cue from these subtle but definite shift in users’ requirement, Agappe Diagnostics Ltd., that had been in distribution and post-sales service of hematology analyzers since its establishment in 1995, began manufacture of reagents and consumables for hematology analyzers in 2002. Building on strength of its ‘in-house’ R & D expertise of developing protein analyzer series Misap i, Agappe set upon the ambitious path of developing fully indigenously designed hematology analyzers in Kochi-Kerala sometime in 2016-17.

Through many trials and hurdles that would have deterred many, Agappe Diagnostics Ltd., successfully completed development of their 3-PDA Hematology analyzer MISPA Count-X in 2019. When several field trials carried out at reputed medical institutions, established robustness of equipment and more importantly the clinical utility of data it produced as compared to well-known international hematology analyzers, Agappe was ready to claim its place of pride in the resurgent Atmanirbhar Abhiyan by Government of India when the global COVID-19 pandemic put brakes in the plan. Notwithstanding that bolt-from-Blue, MISPA-Count-X, was successfully launched in September 2020 for commercial. As this goes to print, Agappe is rightfully proud to share that over it has 500+ installations of MISPA Count-X already spread across diagnostic laboratories. Not sitting on laurels of being the first IVD manufacturer of indigenously developed hematology analyzer, Agappe has already set its next goal, 5-diff hematology analyzer manufactured in India for the world.

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