How the world's cheapest testing kit came to be?
On 30th January 2020, WHO declared COVID-19 as a “Public Health Emergency of International Concern (PHEIC)” - the gravest degree a disease can be attributed to in the WHO categorization. This came much before countries across the globe took due cognizance of the incoming catastrophe, that would reveal the fragilities of their health-care systems in time. This alone begs a question: could we’ve responded promptly and recovered better? Reflect for a moment maybe.
The under-preparedness was ominous at best; India, in particular struggled to respond efficiently and suitably to the rise in the number of cases when the virus hit. One of the major causes of concern, at least in the first quarter of the hastily implemented lockdown, was our testing numbers. Reports were suggestive of the mismanagement of agencies in acquiring the requisite number of kits from abroad, primarily because of their inexperience in the said kind of transactions. This was accompanied by extending invitations to indigneous firms and research institutes, asking them to rise up to the occasion, and develop testing kits and other necessary equipment at home. Swadeshi was to be an important aid in the battle.
Six months past the start of it all, if we are to look back at how things have shaped, there are indeed some encouraging positives to cheer for. While we await the possibility of a peak and the numbers continue to soar without a pause, our response has shown signs of improvement. We’re testing, if not adequate, but far better than what we were earlier. A closer look in this regard is telling of the many indigenous contributions that have made this possible. We at BSP were particularly fortunate to be able to interview the team of professors at Kusuma School of Biological Sciences, IITD who made headlines for producing the world’s cheapest testing kit for COVID-19: Corosure.
The team comprises of Prof. Vivekanandan Perumal, Prof. Bishwajit Kundu, Prof. Manoj Menon, Prof James Gomes, Dr. Sonam Dhamija, Dr. Akhilesh Mishra, Dr. Parul Gupta, Prashant Pradhan (PhD Scholar), Ashutosh Pandey (PhD Scholar), Praveen Tripathi (PhD Scholar).
Hustling amidst the lockdown
The making of Corosure embodies the multidisciplinary nature of research work that is quickly garnering traction and importance. It’s a rather noteworthy fact that all the professors working on the development of kit come from different areas of specialization and augmented each other’s skillset to take the task to fruition.
The team had begun to study the consequences of SARS-CoV-2 soon after the viral sequences were separated and subsequently found two unique regions that were absent in other coronaviruses studied till date. This difference became the basis of the pathway they chose to tread along. A pertinent issue, however, was that IIT Delhi being an academic research institute, the team didn’t have access to any real virus samples for running tests. As an alternative, they had to come up with short in-vitro transcripts of the virus for testing. Logistical arrangements also suffered at the hands of the lockdown, and procurement of any chemical or equipment required permits and formalities aplenty.
With time though, the research picked up the pace, and the team had eight different testing methods, also known as diagnostic assays to try and experiment upon. The end-goal was to optimize them to an acceptable measure of efficacy.
Using comparative sequence analyses, the IIT Delhi team identified unique regions (short stretches of RNA sequences) in the COVID-19 /SARS COV-2 genome. These regions are not present in other human coronaviruses providing an opportunity to specifically detect COVID-19. This method uses primers targeting unique regions of COVID-19 that were designed and tested using real-time PCR. These primers specifically bind to regions conserved in over 400 fully sequenced COVID-19 genomes. This highly sensitive assay was developed by extensive optimization using synthetic DNA constructs followed by in vitro generated RNA fragments (Courtesy: IITD News)
En Route to NIV, Pune
A breakthrough was arrived at after the team successfully optimized one of the assays, that was now to be sent to the National Institute of Virology in Pune for further approval. The team sensed an immediate need to ship the assay to Pune the very next day, given the severity of the lockdown Pune was about to enter into. A delay at this point could render it practically impossible to reach Pune afterward. Luckily, they were able to find a vendor who was willing to deliver the assay to Pune on an urgent basis. The vendor was based out of Connaught Place though; and it posed a different problem altogether.
Movement in Delhi was impermissible barring essential travels, and a host of passes were required to travel outside of campus at that point. It was moonlight when these complicacies arose, and none of the members of the team could make arrangements to reach the vendor within the hard deadline of 8 P.M. Almost miraculously though, they were able to catch hold of Prashant, a student in their department, more importantly, a domicile of Delhi who had the permissions to take his four-wheeler to CP. “It was touch and go,” Prof. Perumal exclaimed before adding that Prashant made it to CP in time.
ICMR Approval and Commercialisation
ICMR approval was the final stage in the queue of formalities. The evaluations at ICMR were telling of the prowess of the team as the kit was passed with a cent percent rates of specificity and selectivity. “It is the maximum a COVID testing kit has scored in ICMR up till now,” Prof. Perumal said.
The team took the necessary steps while commercializing the kits in order to avoid a hike in the price of the kits by the companies. Non-exclusive licensing was thus done to restrict the companies from increasing the prices. Each member of the team had to spend dozens of hours with the company officials, explaining to them the working principle behind the testing kits and the process to manufacture the same.
Prof. Perumal also detailed the larger effect the kit had on the economics of testing, “Our testing kit significantly contributed in bringing down the price of other kits as well. When our testing kit was approved, the rest were selling at around Rs. 1200. The base price of our kit was far below than the average market price at that time and the indication of its arrival lead to a fall in the prices across the Indian market. As a result, currently, the prices of most of the testing kits are around Rs 400-600. This is one of the biggest impacts we have made.”
Team spirit at work
A retrospective outlook at the of the trail of developing a test kit lead to a bunch of heartfelt anecdotes and support stories cropping out of the memory lane. Prof Menon, who had become a part of the IIT Delhi fraternity just a year ago expressed his satisfaction at being able to contribute, “I felt good that I had a role to play in this pandemic. I couldn’t imagine spending the past few months just sitting at home.” Prof Menon in fact considers his total experience in IIT Delhi equal to one plus COVID.
The team gleefully lauded the support of the students and the working staff who were a part of the research cycle, and specifically that of the Director of IIT Delhi, Prof. V. Ramgopal Rao. Prof Bishwajit remarked that the support received from the Director of the institute holds a special place in this journey, “Our director was available 24*7 for the team. The team considers him an equal member of this. It could not have been possible without him.”
“It was a huge learning experience for all of us to work in a constrained environment within a short period of time. This has shaped us as better scientists and better entrepreneurs, which will be helpful in determining our next course of action for the rest of the experiments and research work.,” Prof. Bishwajit Kundu said while summing up the insights the team had drawn from the pathbreaking research.
While the kit has been exceedingly well-received in the scientific community, there are signs of reluctance amongst the market players. Prof. Perumal explained this, “The inertia to change was expected. Our technology is a deviation from current technology. People don’t want to change from the testing kits they have been using for the past 4-5 months. Our testing kits will thus take a few months to fully penetrate the market.”
As of now, the team happens to be working on methods to decrease the time required to test a sample. Another problem at hand is also being mulled over: as the flu season comes in, with every other person having a common cold and flu, it will become very difficult to distinguish b/w COVID and common cold/viral flu owing to the common set of symptoms. The team is trying to work a way out of this overlap.
By Kshitiz Bansal & Prathamesh Singh. Illustration by Agrima Deedwania.