Tuesday, March 03, 2015

India's first swine flu diagnostic kit developed

NEW DELHI: The swine flu flare-up has pushed an indigenous innovation faster into the market, a rare silver lining in an otherwise gloomy narrative, as India battles the worst outbreak of the virus in the past five years. The government has approved in February the first India-made swine flu diagnostic kit, developed by Bengaluru-based Molbio Diagnostics, which promises cheaper, faster results with a portable device.

The kit developed by Molbio costs about Rs 850, less than half the price of most imported kits (which sell for about Rs 2,000 to 2,800) while producing equally accurate results, claims Sumit Mitra, marketing manager, global business at Molbio Diagnostics. The one-time hardware cost at Rs 5 lakh is roughly about one-fourth of other imported platforms, he added.

Molbio, a name derived by combining Molecular Biology, is a 50:50 joint venture between Goa-based Tulip Group that makes and sells in-vitro diagnostic reagents, and Bengaluru-headquartered Bigtec Labs that specialises in portable devices that brings 'lab on chip'. The test also makes it possible to deliver results in an hour, much quicker than about six hours or more other tests usually take.

"The turnaround time for tests on other platforms is longer primarily because it is very expensive to carry out a single sample test on their platforms. Usually, the labs wait to collect a minimum number of samples before they run such tests. Our kit makes it economical to run test on each sample separately, one reason why we can promise faster results in case of many infections," explains Mitra. Another reason why reports take longer is because the conventional hardware is usually bulky and installed at a central lab, where all the samples have to be transported.

Mitra says their hardare is much lighter and easier to operate. Their portable device is also designed to take the sample from the patient's bedside, instead of making him or her travel to where the lab is located. At present, India is almost fully dependent on imports for such kits a lion's share coming from Swiss firm Roche Diagnostics and US-based Life Technologies. Sanjiv Vashishtha, chief executive of SRL Ltd, a national diagnostic chain owned by Fortis Healthcare, which has carried out over 20,000 swine flu tests this season, said, "Innovations are always laudable. But at this time, when the stakes are so high, we have to go with a time-tested model, which has been proved to be fully accurate and safe for our clinicians and health workers working with the samples on a round-the clock basis".

On a daily basis, SRL is testing about 1,500 samples and can ramp up the capacity to 2500, if the need arises, he added. Molbio's platform has been technically ready to test the H1N1 virus since 2013 and is currently installed in 40 labs across the country.

"It was early this year, when flu cases soared, we approached the Centre and got the nod from Indian Council of Medical Research and Drug Controller General of India within a few days," Mitra confirmed. However, the challenges for the firm are far from over. Despite central clearances, the labs equipped with Molbio's technology are struggling to convince their respective state governments that they have the permissions to do the tests, Mitra said.

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