‘We have the ability to scale up production in a few weeks up to 50,000 tests per day’
Pune-based Mylab Discovery Solutions has been in the news recently for developing the first ‘Made in India’ Covid-19 testing kit. In an exclusive interaction, Dr Gautam Wankhede, Medical Affairs Director, Mylab, divulges more details about the Mylab PathoDetect kits to Lakshmipriya Nair
You have managed to develop this test in a matter of six weeks. What have been your major learnings since the need of the hour is more collaboration and knowledge-sharing?
Research and manufacturing high-quality diagnostics has always been our focus. A great example of this is that we are the only Indian company with ID-NAT test approval in India. The experience of the team in developing such tests has been a great help in developing this kit, as per the WHO standards.
Reportedly, the kit shortens the turn-around time to two and a half hours, and has shown 100 per cent sensitivity and specificity in the Indian Council of Medical Research (ICMR)’s evaluation. It is also priced very cost-effectively.
Can you tell us more about the technology and protocols used to develop the Mylab PathoDetect kits?
Regarding 100 per cent concordance, it is a commonly used standard for tests where accuracy is required. Many blood tests at blood banks use the same standards and the Covid-19 also is put to this standard. We are not the only one to achieve it as well. Further, the kit has a unified screening-confirmation outcome which means you don’t have to conduct two separate tests and thus save on time. Moreover, our hope is that with reduced price, it should help make testing accessible and help in reducing spread of Covid-19.
What is your strategy to scale up the manufacturing of these tests? Which facility of yours has been given clearance by the Drugs Controller General of India (DCGI) to manufacture these kits? How soon will you be supplying the first batch of tests, and which government laboratories will get access to them in the first phase?
Our manufacturing facility in Lonavala has been given clearance by the DGCI and we have started supplying kits already. Laboratories specified by the ICMR’s list (which is getting updated by the day on their website) only have the approvals to conduct these tests. Note that these are not home kits. Regarding scale up, we are hoping that India does not have to face that situation, but should there be a need, we have the ability to scale up production in a few weeks up to 50,000 tests per day.
According to you, what more can be done by all stakeholders to battle and vanquish this threat of coronavirus?
I think government is taking all the necessary steps. The leadership in centre and all the states is quite serious about this issue and are taking full-scale actions. The only request I have is, to fellow citizens, is to observe social distancing discipline and help the country.
The role and importance of molecular diagnostics have been underlined in the current scenario. How conducive is India’s ecosystem to foster innovation in this sector?
India has a strong body of knowledge, world-class institutes and a deep pool of educated manpower. This makes us well-positioned. If you look at the adjunct industries, for example, pharmaceuticals and biologics, the presence of world-class companies in both, manufacturing and development, is evident of the conducive ecosystem.
What’s your message to peers and other stakeholders in the healthcare sector?
I would encourage entrepreneurs to take up the tough problems in healthcare. With a disciplined approach and focus, we do have a chance to change the status quo and develop world-class solutions.
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