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Accelerating indigenous manufacturing for COVID-19 diagnostics and vaccine

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Indian industry and government bodies are working together to achieve a common goal of developing a cost-effective rapid diagnostic method and to identify the vaccine target against COVID-19

India, at some point of time, will need to become self-reliant in producing diagnostics tests and identifying vaccine targets for COVID 19. Well, the good news is that the government is providing some stimulus with its multi-faceted efforts including research towards the development of therapeutics and suitable animal testing for coronavirus as well as the development of indigenous diagnostics and genomic studies on the host and pathogen.

On 28th April, 2020, the Department of Biotechnology (DBT) and its public sector undertakings, Biotechnology Industry Research Assistance Council (BIRAC), had announced a COVID-19 Research Consortium Call to support diagnostics, vaccines, novel therapeutics, repurposing of drugs or any other intervention for control of COVID-19. Similarly, NITI Aayog launched a new initiative called Project CARD (Consortium for Affordable and Rapid Diagnostics) which is a unique public-private-academic partnership enabled by the Government of India where a platform is provided by the NITI Aayog in close collaboration with DBT to synchronise all stakeholders for a common and urgent goal towards accelerating COVID-19 diagnostics in India. The move came after India faced quality issues with China-made antibody testing kits, which are used for disease surveillance and to find out how many people have developed immunity to a disease. Project CARD’s first goal is to roll out at least 10 million rapid antibody tests for Covid-19 by July. Additionally, capacity will be expanded to make reverse transcription polymerase chain reaction (RT-PCR) and other paper-based tests for Covid-19 in the country.

In the same light, Gujarat Biotechnology Research Centre, an autonomous institute under the Department of Science and Technology (DST), Government of Gujarat, recently partnered with Neuberg Supratech Reference Laboratories (NSRL) to achieve the common goal of developing a cost-effective rapid diagnostic method and to identify the vaccine target against COVID-19. NSRL, Ahmedabad is the only CAP- and NABL-accredited genomic centre of excellence in Gujarat. A team of dedicated physicians, scientists and bioinformaticians will help accelerate research on COVID-19. The team includes Dr Sandip Shah, Dr Bhavini Shah, Dr Parth Shah, Dr Shiva Murarka Joshi, Dr Vishal Nanavaty, research technician team and bioinformatics team (NSRL) and Dr C G Joshi, Director, GBRC as well as Dr Madhvi Joshi, Joint-Director, GBRC.

Now, what makes this endeavour promising is that if the project attains its goals, India will be able to produce diagnostics kits at an affordable cost.

Dr Madhvi Joshi (GBRC), informed, “GBRC is a translational research centre of state government and together with Neuberg Supratech Reference Laboratory (at Neuberg centre of Genomic Medicine, part of global Neuberg Diagnostic), we will be working on improving existing diagnostics method of COVID-19. We also intend to identify for potential vaccine candidate leveraging our combined genomic strength.”

According to NSRL, there are two proposed projects on COVID-19 under this MOU. One will look to optimise the methods of screening for COVID-19 positive individuals and the second one will study the immune profiles of COVID-19 patients and correlate them based on their clinical outcomes. These projects currently utilise a multitude of technologies, including next-generation sequencing, single-cell genomics, immune repertoire studies in addition to novel peptide analysis.

“We believe the successful completion of these two projects will provide us with two potential solutions for the fight against COVID-19. One, testing for COVID-19 will be rapid and cost-effective. More diagnostic labs will be able to implement our protocol which is a major problem in early detection of the spread. A major focus of our work is to enable utilisation of commonly available reagents which will allow for easy deployment. Two, we will have a comprehensive database of the immune response in COVID-19 positive patients. This will serve as the backbone for target identification. Besides the potential target identification, we will be able to understand the virus strain well and calculate the rate of mutations in several regions. We will also be able to identify the most vulnerable population based on their genetic makeup. The knowledge of this genetic makeup will help patients to fight against COVID-19 as well as will educate them about future virus infections. Given our role as a large central laboratory, we hope to work closely with hospitals and patients to build a strong clinical database to allow for better data validity,” elaborates Dr Sandip Shah, Executive Director, Neuberg Diagnostics Private Limited and Director, Neuberg Supratech Reference Lab, Ahmedabad on the significance of these indigenous projects.

Here are more details on the Gujarat Biotechnology Research Centre projects agenda.

Project 1: There is an immediate need to bring the cost of testing under an affordable range for the Indian population. NSRL has identified four areas in current testing protocols that need to be optimised to bring the final cost of the test under Rs 1,000. Current cost for the RT-PCR based COVID-19 testing is capped at Rs 4,500, which requires around Rs 3,000 worth consumables for the assay. Preliminary data generated in NSRL has already shown a path towards bringing the consumable cost to less than Rs 1,500 with further optimisations allowing this cost to be halved.

Project 2: NSRL and GBRC under this project will identify specific immune markers responsible for differentiating severe vs asymptomatic COVID-19 patients. For patients recovering from COVID-19, they expect to use their blood samples to characterise the antibodies that have helped in their recovery. We also aim to understand the genetic makeup of the population who develop mild symptoms or stay asymptomatic throughout infection. Results obtained from these studies will help us to identify the genetic markers in the population which potentially leads the patients towards severe COVID-19 infection.

Currently, there are over 600 ongoing clinical trials to achieve the same goal. It is well known that the genetic makeup of different country’s populations modulates the clinical outcome of the virus infection differently. Under this project, they will enroll COVID-19 positive patients for studies and identify the strain of the virus by sequencing the genome of the virus, this will help us to know the virus well. They will study innate and humoral immune markers from each individual enrolled under this study that will help us to differentiate the genetic makeup of each individual. Finally, they will look at the composition of anti-body response in each enrolled individual, which will potentially help us to identify vaccine targets against COVID-19. Their study will also help in understanding more about the nature of virus infection and this will help us to better prepare for future virus infections.

While there has been significant progress in the development of a low-cost test for COVID-19, work-related to the vaccine project is currently under execution of sample collections from a variety of patients, discloses Dr Shah. Appropriate ethical committee clearances and reagent procurement have also been initiated for the clinical studies and they have also applied for a detailed grant to the ICMR for funding support. They expect to have an outcome on the diagnostic project within four to six weeks; while for vaccine targets, we aim to finish the project in one year.

As informed by the officials from Niti Aayog and the Department of Biotechnology, Trivitron Healthcare, Syngene International and Reliance Industries are three other companies working on antibody test kits in India who will be getting the initial support in terms of procurement and availability of testing facilities to manufacture the kits.

All the same, India’s efforts in accelerating indigenous engineering, and scientific evidence to combat COVID-19 is noteworthy; a clear indication of an approach that is multi-pronged and prudent. As our fight against the virus continues, we hope that all these indigenous efforts gain success in the months to come and help us to build a resilient healthcare system for India.

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