On January 30, 2020, the first case of coronavirus (COVID-19) was confirmed in the country, in Thrissur, Kerala. But at a young, private molecular diagnostics company in Pune, efforts were already underway to create a COVID-19 testing kit.
At the MyLab Discovery Solutions, a small team of people had the foresight to grasp the enormity of what was coming. “We started to keep an eye after it began expanding outside China,” says Hasmukh Rawal, Managing Director, MyLab Discovery Solutions. “It was gradually becoming clear that this could transmit from human to human. When the first case registered in India, we sped up our work.”
At the time detection in India started, there was no approved testing Indian kit – what was being used by medical practitioners were kits the government was importing. Rawal and his team knew that at the most basic level, given the rate at which the spread was, more local kits were needed. He set up a dedicated R&D team, which would eventually go on to create PathoDetect COVID-19 Qualitative PCR kit, the country’s first homegrown COVID-19 testing kit from MyLab, in a record time of six weeks.
Based on the extraction of genetic material of the virus from the sample, which is polymerized to make copies and then identifying it based on genetic signatures, PathoDetect, made as per WHO/CDC guidelines, is better than most kits currently available in the market. It has a unified screening-confirmation outcome, which means you don’t have to conduct two-step tests, thus saving on time. It also takes two-and-a-half hours compared to seven other similar RT-PCR tests take. It can detect early-stage infection, and at Rs 1,200, is cheaper.
PathoDetect is the culmination of the efforts of a 10-member team led by Minal Dakhave Bhosale. Alongside her were Shefali Desai, Director of Application Support and expert in molecular diagnostics, cell biology, protein chemistry, and genetics, who was instrumental in building the kit, and Mitali Patil, who heads Quality Management and ensured the test met all the criteria for approvals (PathoDetect achieved 100% concordance). As R&D lead, Bhosale worked on the design and evaluation of this COVID-19 testing kit by MyLab.
The group worked in tandem on three different areas to deliver the need of the hour. Most of the core team members have been with MyLab since it started in 2016, with the seniormost being Desai (62), and the junior most, research assistant Utkarsha Jaware (24). Most members are in their late 20s and mid-30s.
If the race against time wasn’t enough, Bhosale says the biggest challenges in developing the test included limited availability of positive samples of COVID-19, and achieving a test which had high sensitivity and specificity. Stress was a constant companion, but the team relied on the senior members to bring stability. “We had to remain extremely focused and calm because we needed to remain emotionally unaffected by what was going on outside,” says Bhosale.
Bhosale has also become the reluctant face of the success of PathoDetect for another reason — she was in the late stages of her pregnancy when the test was in the final stages of completion. Though she says the pregnancy didn’t make things easier, it certainly gave her a lot of strength to carry on and get the test kit right. “My family, my team and the company management were there to support me in all ways they could. And I am happy that in the end, it turned out well.”
Working on a highly infectious virus while pregnant, and also managing complications in her pregnancy — Bhosale didn’t let either affect the speed at which the test needed to be delivered. Did she ever fear for her health? “When the country calls us, we have to respond. I had to do what I had to do,” she says simply.
On March 17, 2020, test trials were completed late night. The very next day, the MyLab COVID-19 testing kit was submitted to National Institute of Virology, Pune, for external evaluation, alongside a proposal to the Indian FDA and Central Drugs Standard Control Organisation for commercial approval. On March 23, the approval was received. On March 19, Bhosale delivered a baby girl.
Naturally, working on a high-pressure project such as this has come with learnings. “Discipline and belief is the essence of success. The team was comfortable working with each other which made the development clockwork and reduced errors. About myself, I learnt that there is no limit to what we can do,” says Bhosale of the experience.
One of the biggest concerns about the pandemic has been the lack of testing equipment and number of people being tested (India still has one of the lowest records for the number of people being tested per million). Last week, MyLab, which also manufactures ID-NAT screening kits for blood banks/hospitals, Quantitative HIV, HBV and HCV kits, signed a partnership with the Serum Institute of India to scale up production from 1.5 lakh kits per week to 20 lakh per week. “What relieves me is that our expertise and capability came to help the nation at the right time,” says Rawal. “Makes me feel that we could make a contribution.”
All images: Courtesy MyLab