“We want to be a leader in genetic diagnostics as a differentiator and not as a me-too player”

November 16, 2021 0 By Gopakumar

Tony Jose, Co-Founder and CEO of Bangalore-based genomics company Clevergene that claims unrivalled discovery-genomics and genetic diagnostics capabilities, had a personal reason to take a deep interest in genetics. As a child, Tony Jose was intolerant to milk and suffered regularly from problems like vomiting, stomach cramps and other reactions till the age of 6 or 7, which even affected his schooling. Doctors couldn’t diagnose the problem and instead treated him with anti-infection medications. Since he was lucky to have just one copy of the mutation that causes Galactosemia, the issue became less severe over time. But, says he, no one knew about the disease and the genetic mutation that caused it 38 years ago. He himself understood it only when he started his career with a specialty diagnostics company in Hyderabad a few years ago. 

So, for this young science entrepreneur, genetic testing with the highest level of resolution to pick rare genetic disorders is not only a business mission but also a social commitment to help millions of people who either live with such undiagnosed diseases or get the wrong treatment. 

Clevergene, a deep-tech company offering genomics services for contract research and genetic diagnostics, increased its capacity to over 1 lakh annual tests with the installation of what the company claims is the most advanced DNA sequencer in the world. This puts it in an elite club of organisations around the world that can analyse tens of thousands of human genomes. However, says Tony Jose, the primary intention behind the investment was to scale up the company’s genetic diagnostics portfolio and make genetic diagnosis available to millions of patients. Excerpts of an exclusive interview with Editor CH Unnikrishnan

 Why go for such a large-scale capacity expansion now? 

 The scaling up of capacity and technology with the installation of the latest Illumina NovaSeq 6000 DNA sequencing platform will open new horizons for high powered experiments at the depth required to discover rare genetic events. With this addition, we will also be able to widen our discovery genomics offerings by introducing applications such as single cell gene expression, genome deep sequencing etc. This requires large volumes of DNA sequence data. So, we are also aiming to lead genetic diagnostics with a focus on providing diagnosis for rare and difficult-to-diagnose genetic ailments. 

While our primary intention behind this investment is to scale up our genetic diagnostics portfolio and make available comprehensive genetic diagnosis to the millions suffering with genetic ailments, we are also expanding our discovery genomics offerings to Europe and North America.

I think the addition of this critical piece of infrastructure will immensely help top life-science research institutions, specialty hospitals and diagnostics companies who have been looking for a partner in Genomics with capabilities in high-throughput sequencing and deep-tech genome analysis. This investment has actually augmented our already strong testing abilities and puts them in a strong position to partner global discovery genomics projects.

 Two of your collaborations in the initial years have been very crucial in establishing Clevergene as what it is today in the genomics and genetic testing market. How did they come through and how helpful they were?    

 Yes, that’s right. I actually started as a consultant to pharma companies and other clients who wanted to enter into genomics. But soon realised that consultancy is not really a scalable model.  So, I realised that my core competence lies in genomics and I could do better in that and I brought in some more experts who were my friends and colleagues, and started genomics. One major boost that we got was an Mou with Jawaharlal Nehru Centre for Advanced Scientific Research (JNCASR) in 2016 to use its advanced high-throughput genomics facility. JNCASR had built this Rs 10 crore facility but was looking for a partner to manage and operate it and in return the partner could use the same for their business as well. This still running MoU gave us the required infrastructure for running genomics service business and that’s how we got into the full fledged genomics operation. As you know, this was a mutually beneficial arrangement as the main issue with a genomic facility is not setting it up but to have a competent team to run it. Therefore, with the capability that we had as a skilled team, we could launch a Next-Generation-DNA-sequencing-based discovery genomics service the same year. The next boost was the strategic acquisition of InterpretOmics, which had raised a significant amount of money, but was figuring out how to scale up. This deal not only helped expand the genomics lab capacity but also gave us much better credibility to raise the seed round of funding.               

 Genetic diagnostics is a subject that is close to your heart. Is that the reason to form The Gene Lab as a separate unit with high emphasis on research and investment? 

 Yes, as you said, I was suffering from Galactosemia in my childhood. But, neither my parents nor the doctors had any clue about this because the science of genome sequencing wasn’t there and one can’t even think about its applications for diagnosing diseases. I myself realised it was Galactosemia when I started my career with a diagnostics company that was into biochemistry-based diagnostics for tracing genetic diseases. So, this was always there and when we had the capacity to sequence and analyse genomes as part of Clevergene’s discovery genomics business, we thought why not [venture into] its applied field too. That’s how we started The Gene Lab, which is the clinical diagnostics arm of Clevergene. Currently The Gene Lab focuses on diagnostics for pediatric genetic ailments. Going forward, the whole motto of The Gene Lab is rapid diagnosis of genetic disorders, enabling screening and prevention of these diseases.   

Truly speaking, The Gene Lab was launched over a year ago, just before Covid-19 hit the country and OPDs were closed, with hardly any prescriptions. Naturally, we couldn’t make any headway.  But we laid low and tried to refine and further improve our products before going to the clinicians once things started getting back to normal. This also gave us time to strengthen the team with more and better geneticists and clinical diagnosticians, making our capability and skill sets much superior in the industry. This has in fact allowed us to look at these disorders and diagnosis from a different perspective because what we believe is that genetic diagnostics should be considered as a genetics problem rather than a genomics problem. Genomics is a tool of technology to sequence the DNA cost effectively and faster. But, when you come to actually looking at the patients’ symptoms and phenotypes and correlating them with the data that you have received, you really need to put the fundamentals of genetics into play. This is really helping us diagnose better and our hit rate in terms of conclusive diagnosis of pediatric genetic disorders is currently more than 80 percent, which is about 30 to 40 percent higher than the industry standard in India. It gives us immense confidence in scaling up that vertical. Moving forward, our idea is to establish a command in pediatric genetic diagnostics in India and we are also looking at the global market for genetic diagnostics and genomic research. 

 Why do you focus only on the postnatal segment and why not prenatal screening, like many of your competitors?   

 We have a roadmap in Clevergene which is to discover, diagnose, screen and prevent. In discovery, we have already made a mark and are going strong with new collaborations and client acquisitions. In the diagnostics space, as mentioned earlier, we are only into the postnatal segment at present and we think that we still need to consolidate our position by getting a real good hang of it, though we already have an edge in the market now with the most comprehensive and conclusive results. As the next move, we are looking at prenatal screening with our own non-invasive prenatal genetic testing (NIPGT), which is under development now and will have better resolution in terms of identifying even smaller anomalies in the DNA. The currently available non invasive prenatal testing (NIPT) only looks at a few chromosomal abnormalities and some micro deletions that are known. But, with NIPGT, what we want to do is to have a complete end-to-end control over what we are doing instead of just buying a kit which was developed by someone and continue following the same method. Parallely, we are also working on carrier screening, which is again available in the market, I wouldn’t want to deny the fact. But what we see in the market is that mostly these kits are developed by somebody and others have just adapted them. However, for some reason, nobody really wanted to go back and check whether what they are adapting is the latest, or has the technology undergone any changes over these years. The number of human genomes sequenced in the last five years is significantly higher as compared to the number that was sequenced before. More importantly, there have been newer disorders that were identified and many more markers have been developed over the last few years. So, ideally one should go back to the drawing board and do a check rather than blindly adapting the same that has been available in the market and we feel that this chain of adapting somebody’s technology by another one should be broken. That’s what we are working on. In brief, we want to be the leader in the genetic testing market as a differentiator and not as a follower. While our own NIPGT and the differentiated carrier screening are next in line, we do not want to get into the predictive test domain immediately.