The following interview with MyLab Discovery Solutions Pvt. Ltd. traces the journey of the firm as it takes some decisive steps to deal with the ongoing pandemic, COVID-19. The discussion highlights the firm’s success in the development of the first commercial test kit, its scientists’ arduous work, and what lies ahead of the firm in the healthcare realm.
Here are the excerpts of the interview.
Please brief our readers on what went into the making of the first ‘made in India’ commercial COVID-19 test kit.
The development of a test kit includes a lot of steps and parameters to check. Major steps include the design of the assay for accurate detection, procurement of raw material, standardization of the test parameters followed by the validation of the test for analytical sensitivity and specificity, its clinical performance, generating quality control specifications, and government approvals.
There were 2 key challenges that we had to work with: a) We had to develop a test which will be very accurate (100% sensitivity and 100% specificity), b) We needed to ensure that we do that fast so that the test is available quickly. The pandemic was already spreading, and we were running against time.
With project management, stringent protocols, and technical expertise, we were able to overcome the challenges and able to develop the first Made in India test for COVID-19 in a record time of six weeks.
In what ways did the government provide support/initiative to your company?
However, we would like to thank the industry bodies and the government. The officers and the scientists at these organizations have worked extra hours to evaluate the tests submitted to them and to issue a license quickly after the evaluations were found satisfactory. Financially, ours is a private limited company. However, we would like to make a disclosure that after the approval of the test we have been selected as one of the recipients of the COVID Action grant.
Can you explain it’s functioning in layman terms in order to make the general public aware of the COVID-19 testing kit?
This is an RT-PCR based kit that can accurately detect COVID-19 infection in symptomatic and non-symptomatic patients in a short period of time (2.5 hours). It is based on the extraction of the genetic material of the virus from the sample and then using PCR to make many copies of it. Then identifying its basis of genetic signatures.
Please introduce the leadership team at MyLab that made this mammoth task a success.
The firm was founded by Shailendra Kawade and Hasmukh Rawal in 2016. Both of them have worked at US-based laboratory equipment giant and made up their mind to develop diagnostic solutions that are affordable and unique. Until now, Mylab has been self-funded.
The company employs an in-house team of scientists, most of them being women. In total, we have 50 employees at a manufacturing facility. The leadership team includes Dr. Gautam Wankhede, who is the Clinical Director. Then Ms. Shefali Desai, who is the Director of application development and then the business team, which includes Mr. Debarshi, Mr. Sujit, Mr. Rahul Patil, and Mr. Srikant.
What challenges did you face throughout the entire production timeline of the test kits?
While in production, we are working to scale up. We are also working with various organizations to ensure that we are able to procure raw materials and deliver kits to the labs across the country. We have recently partnered with the research and development wing of Biocon’s Syngene to further indigenous the test kit.
What are the other areas of focus for MyLab?
Mylab is India’s first FDA (CDSCO) approved manufacturer for ID-NAT based molecular diagnostic kits for detection and quantification of HIV, HBV, and HCV. This is used at blood banks and hospitals and reduces the chances of infected blood being provided to a patient.
In the coming years, molecular diagnostics will continue to be of critical importance to public health worldwide. We are making solutions to help patients, particularly in the fields of cancer, infectious disease, and congenital abnormalities.
As industry experts, what are your opinions on the current global crisis, and according to you, how much is it going to affect the world?
In our view, this will change the way the world works and approaches every aspect of life. The change will be huge, but then the human race has won many such battles, so we are hopeful.
What is MyLab going to work on in the future with respect to the COVID-19 crisis as well as from the business perspective?
From the business perspective, we will continue to develop newer tests that can help people detect cancer faster, detect infections, and also tests to see if the food is safe.
