Coronavirus breakthrough: India gets its own testing kit for Covid-19

Big development being reported as a major step in fact in this fight against #coronavirus. India gets its own testing kit it's a big breakthrough in the #Covid-19 testing.  In fact, a lab has received the ICMR approval as well that has made this indigenous Covid-19 test kit a Pune based molecular diagnostics company which specializes in molecular diagnostic kits has developed first made in India test kit for Covid-19 in a record time of 6 weeks. The kit My Lab Patho detect Covid-19 qualitative PCR kit is the first one to receive commercial approval from the Indian FDA and the central drug standard control organization. My lab is the only Indian company to have achieved 100% sensitivity and specificity in the ICMR evaluation.

Coronavirus breakthrough-India gets its own testing kit for Covid-19

"Dr. Gotham Wankhede a director of the medical affairs of My Lab discovery Solutions Private Limited".

Conversation with Dr. Gotham Wankhede-

Sir our congratulations to you this is good news coming in my first question is your claim to have manufactured a #Covid-19 test kit can you tell us more about this and how soon can we expect this kit in the market?

So My Lab discovery has just got the approval from ICMR and CDSEO or the Covid 19 kit based on the real-time PCR and I would, first of all, like to thank CDSEO and ICMR and everyone at NIV for the speed at which they evaluated this kit and given us the license to go ahead.

Now we just got the license yesterday evening and our team as we speak has already started putting in all the efforts and they have you know working very hard. We hope to get the first batch of kits out hopefully by end of tomorrow or no all tested and QC they have tomorrow early morning. We should have started supplying the first batch.

How did you achieve this breakthrough the science and the effort behind getting this together?

First of all hats off to the team of our Mylab team they've really put in a lot of effort over the last two and a half months. So basically one good thing here was that the WHO on CDC made the genome public. So normally this is usually kept with the researchers but all the manufactures in the world knew that this is the particular gene that we have to target. 

If we have to detect Corona and then our team got down they developed you know the right concentration right amount of testing was done to develop this kit Corona. We could not only detect the right cases but also you know not to have any cross-reactivity false positivity so hats off to our team they work really hard. And you know over the last two months they did all of them have been working 16 to 18 hours a day and when we got the report from ICM our last afternoon we knew we are going to get a good report so it was not a surprise for us but it was a big relief for us that all the efforts are finally you know given us results.

Dr. Gotham Wankhede, India is currently importing the test kits from countries like Germany and Switzerland do you think this dependency will you know we reduce once your kits are available in the market?

Definitely, you see what the population in India and you know the way experts are talking about the situation may get even worse at stage 3 coming in we would definitely require a lot more testing at least. We should be prepared for the worst-case and being completely dependent on foreign-made kits or foreign suppliers you know international suppliers. Mean if they're in Chile hopefully not mainly to a problem where if they decided not to supply for whatever reasons, for example, the flights may stop coming in and then the country may be in a big problem. So that's why it's very important to have indigenous suppliers of good quality kits ready just in case we reach a stage where we require a lot of testing to be done across the country. 

Well, the next obvious question obviously is going to be about the price of this testing kit I CMRS appeal for private labs to conduct this test for free? You think you know you can provide this at a nominal cost or price point. 

So IRIS, as I said a little while back our team is working we hope to get the first batch of kits out hopefully by Nvidia tomorrow or worse case day after tomorrow, see we have a manufacturing capacity of about 15,000 tests per day and we can reach that in two to three days time we are hoping to scale it up and go up to 25 to 15 a thousand tests today if required in the next eight to ten days and as far as the pricing is concerned I think the government has given a pricing cap of about Rs.4,500 to the private labs now we tried as we trying a best to give it a price of you know one third or maybe one fourth the price of that to the laboratories.

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