'India has a population of more than 1.26 billion people, with 26 million births occurring every year. This means that the burden of a genetic disease is very high.'
The Indian diagnostics industry has been rapidly evolving over the years and it’s emerged to be a key component of the healthcare segment. The arrival of Covid-19 pandemic pushed the healthcare industry to the sting worldwide by throwing many challenges, and therefore the diagnostic sector too witnessed a large transition during this phase. Whether it’s about keeping pace with the concept of telemedicine or addressing the change within the consumer psyche, the diagnostic sector has been facing different challenges with the increase of covid cases. As COVID-19 has spread, India’s diagnostic sector has been battling the virus at the forefront. In conversation with Financial Express Neeraj Gupta, Founder and CEO of Genes2me shared his experience and threw light on the challenges, learnings, and therefore the road ahead for the diagnostic businesses in India. Excerpts:
How has the diagnostic sector evolved since the arrival of Covid-19? Being an industry leader, what were some initial challenges you faced?
Previously, the molecular diagnostic sector was not harnessed. We have seen that pandemic pushed the healthcare industry to the edge, but India’s diagnostic sector rose to meet the challenges. As COVID-19 has spread, India’s diagnostic sector has been combating the virus at the forefront. Initially, the Indian health care system was not fully prepared for such a massive crisis like COVID-19. We faced challenges regarding imports for raw materials and logistics due to global supply chain disruptions. This is also one of the reasons why we decided to use our expertise in molecular diagnostics and expand the portfolio into IVD manufacturing.
How has Genes2me come to the forefront during the pandemic? Tell us about your journey of delivering 40 Million covid test kits in India to date.
We take pride in the fact that Genes2Me has been working at the front line from the very first day of the pandemic. We developed several IVD kits, including Real-Time PCR Kits, VTM Kit, RNA Extraction Kits, NGS Kits and multiplexed genotyping assays for COVID-19 detection in a quick turnaround time.
Our ViralDtect-II Real-Time PCR Kit for COVID-19 has been a real turning point. It was the first Made in India Real-Time PCR Kit with comprehensive coverage of three genes that are specific to SARS-COV-2.
Also, there have been reports of new strains of SARS-COV-2 being detected. Genes2Me has developed a Unique Mutation Classifier assay that can rapidly differentiate 40 variants between 16 SARS-CoV-2 strains. This can help in the quick genetic screening of large sections of the population.
Genes2Me have been working tirelessly and have delivered more than 40 million COVID-19 testing kits to date. Also, to meet the sudden demand surge of the second Covid wave, we ramped our manufacturing facility from 9million per month to 6 million per week. In fact, during this time, Genes2Me contributed over 20% of the entire Indian testing needs for RT-PCR.
From where the idea of stepping into manufacturing IVD kits came under the Make in India initiative? What have been the challenges and opportunities?
When the pandemic hit us, not many diagnostic labs had the necessary infrastructure or accreditations to offer Covid testing facilities. As the pandemic gathered force, there was not only demand for faster testing but also testing in much higher volumes. The response to that struggle was the idea behind IVD kits under the Make in India initiative.
The Indian government has taken progressive steps to boost the capacities of the domestic IVD sector. Genes2Me is also working to collaborate with the government and prestigious medical institutes to offer services on the innovative classifier panel of SARS-COV-2. In this manner, we can all be better prepared to face the challenges posed by this virus frequently changing genetic makeup.
What changes should diagnostic companies bring to fight the pandemic and meet the current market demand?
Post Covid-19, we have seen the entry of many companies into the Molecular Diagnostics Testing and Kit Manufacturing segment. Unfortunately, not many companies have been able to deliver quality genetic solutions in a fast turnaround time. This is evident from the fact that around 10-15 players used to compete in the Tender queries of IVD products till last year. But now, only 4-5 bidders are participating in the Tender queries as most of the companies have failed to satisfy customer expectations of Quality Product.
If you want to build a sustainable diagnostic company, you should maintain Quality Manufacturing and Testing Standards. Genes2Me has responded by building capacities and training faster to keep up with the surge without compromising the sensitivity of Genetic Solutions.
What have been some recent developments and future plans of Genes2me?
Genes2Me is vigorously working to leverage the large installed base of molecular testing platforms across the globe. With the help of our expertise and access to advanced technologies, we have developed several assays for Infectious diseases, Oncology and Reproductive Health in India. In the past, most of these test panels were import-dependent from other countries.
In addition, under the Make in India initiative, we are working to develop diverse nucleic acid research and diagnostics solutions along with NGS reagents for genome sequencing. Again, these solutions were dependent on import from different nations.
Genes2Me has also ramped up Covid-19 testing facilities by installing more infrastructure, hiring manpower and training them meticulously to ensure smooth functioning. Our advanced high throughput Real-Time PCR testing Lab at Gurgaon, Haryana, has an unmatched capacity to perform 8K-10K tests per day.
How do you see the future of Genetic Diagnostics in India?
India has a population of more than 1.26 billion people, with 26 million births occurring every year. This means that the burden of a genetic disease is very high. With the help of genetic diagnostics, many diseases can be predicted with great accuracy. If genetic testing is done at the appropriate stage, some diseases can be prevented, cured or managed better.
Genetics diagnostics in India is on the verge of transformation. There has been widespread awareness and recognition of the increasing incidence of congenital and hereditary genetic diseases in urban India. More and more people are seeking genetic testing and counselling services. Genetic diagnostic in India will evolve from a niche speciality to a wide scope of applications for complex diseases and personal use.