On March 18, virologist Minal Dakhave Bhosale hit a major milestone. She and her colleagues submitted India’s first native COVID-19 diagnostic test for validation by the National Institute of Virology. Hours later, Bhosale achieved another milestone. She gave birth to a baby girl. The research team had worked tirelessly for six weeks to prepare the test kit during Bhosale’s final trimester. She even pushed through a pregnancy complication to ensure the test could be used across the country as quickly as possible.
“This was the time to work and develop a test for the country that could be used reliably. It is true that the hours are longer, but then the reason why we are doing this is bigger than an individual,” Bhosale tells The Scientist. “It was challenging to work until the end, but then it was a team effort.”
Helping Bhosale create the country’s COVID-19 test was a group of 10 people—nine are women, and many are mothers. They work for MyLab Discovery Solutions, a biotechnology company based in Pune that develops and commercializes molecular diagnostic detection kits for parasitic, viral, and bacterial infections. One of the company’s products is a kit to screen blood donors for HIV, hepatitis B, and hepatitis C.
As the researchers watched COVID-19 spread around the world, they knew they needed to make a test kit and do it quickly. “Other countries had coronavirus spread ahead of India, and there was already a situation where it was very difficult for any country to source kits and supplies in large quantities,” says Gautam Wankhede, MyLab’s director for medical affairs. “Every country had to put their interests first.”
The MyLab team recognized that, as the virus spread, importing test kits would become too slow and expensive to keep track of infections among the country’s 1.3 billion people. “A testing kit developed in India was necessary to have,” Wankhede says.
Bhosale and her colleagues drew on their experience developing DNA and RNA tests for applications in clinical, veterinary, and food safety settings, and also on the work of researchers who had studied the SARS family of viruses extensively in the past. Following the World Health Organization guidelines for COVID-19 tests, Bhosale and colleagues put together the reagents they’d need to extract nucleic acids from patient samples and to carry out real time PCR. They also gathered materials to work as controls for positive and negative tests.
Testing by the National Institute of Virology showed that samples collected with the kit, when analyzed with the help of a PCR machine in the lab, provide a positive or negative result within 2.5 hours—less than half the time it took imported kits to return an answer. And results came in with an accuracy of 100 percent, according to the Indian Council of Medical Research, an organization similar to the National Institutes of Health in the US. MyLab’s kit, called PathoDetect, is cheaper than the imports too, with each test costing around 1,200 Indian rupees or roughly US $16. The foreign tests were double that or more.
PathoDetect came at an opportune time. In March, the Indian government was facing intense criticism for lack of testing. To push the kit through to the National Institute of Virology in six weeks, rather than the standard four months for these types of tests, marked a record for MyLab.
“For a group that has been actively involved in making PCR test kits for other diseases, it’s not unheard of that MyLab could make a coronavirus test kit in a matter of weeks,” says Prashant Yadav, a senior fellow at the Center for Global Development in Washington, DC, who studies healthcare supply chains and is a coauthor of a recent piece calling for more testing in India. “I think the reason we are all talking about MyLab today is because they had an early start.” Most companies in India didn’t start working on COVID-19 tests until March or April, he says.
That early start coupled with the national pride of having a test kit developed in India opened a lot of doors for MyLab, according to Yadav, who does not have ties to the company. Because MyLab pivoted so quickly to make a coronavirus test kit, it garnered early support from government departments and funding agencies, and had the ability to have quick, direct conversations with scientists at the Indian Council of Medical Research. “I think all of those things worked in favor of MyLab and everyone gave them the sort of expedited critical path support, which probably led to the condensed timeline,” Yadav says.
Every country had to put their interests first.—Gautam Wankhede, MyLab Discovery Solutions
On March 26, eight days after MyLab submitted the kit for validation, the National Institute of Virology approved it for distribution countrywide. Since then, “we have been able to cater to a lot of demand. We have manufactured more than one million tests and supplied tests to more than twenty states in India,” Wankhede says. “We have been working on double shifts to ensure that the testing capacity of India does not get blocked.” The company can now manufacture more than 1.4 million tests per week, he says.
“Even for some of the larger, more known and tested manufacturers in the US that scale up, going from a few thousand to a million kits per week required a lot of work,” Yadav says. Once again, he says, MyLab was most likely aided by its early start and by partnerships with larger companies, such as Syngene International, a contract research and manufacturing organization. MyLab also recently partnered with the Serum Institute of India, a Pune-based vaccine maker. The investment from the institute allowed MyLab to increase production of PathoDetect from 200,000 to 2 million kits per week, says Adar Poonawalla, Serum’s CEO. In mid-May, the Indian government also announced it had given 30,000 PathoDetect kits to Nepal.
Yadav says that test kits from MyLab, and now from other companies that have government-approved kits, are helping to meet the needs of India’s large population. But there is a significant limiting factor. “The PCR machine itself is a constraint,” he explains. Even if the number of tests available reaches a level adequate for the country’s population, the government needs to ensure that there are enough suitably equipped laboratories to process the kit samples. “I don’t think the manufacturing capacity of test kits will be the concern,” he says. “It will be the labs and the system.”
This story is part of a series by The Scientist on how researchers around the world are pitching in to aid the effort against COVID-19.
Click through to find out about more projects that research teams in other countries are working on.