Nobody Would Believe Us That An Indian Company Can Deliver Such Results: Sriram Natarajan

Molecular Diagnostics, a process of identifying diseases by studying molecules like proteins, DNA and RNA is gaining ground in the country. As Goa based molecular diagnostics company going by the name Molbio Diagnostics now offers a point of care solution ‘Truenat’ for the molecular diagnostics testing. 

The company recently secured funding of around Rs 680 crores from a Singapore-based investment firm Temasek in September and became the 108th Unicorn of India, the company is now valued at around 1.6 billion dollars. In the fiscal year that ended in March 2021, Molbio reported a revenue of Rs 1,272 crores on the back of high pandemic-induced demand.

Molbio currently operates out of southern India with its three manufacturing facilities (one in Vishkapatnam and two in Goa) and one research and development unit in Bangalore. 

Sriram Natarajan, Director, Molbio Diagnostics spoke with BW Healthcare World at a media round table organised in Goa.

Excerpts:

Tell us about the journey of Molbio Diagnostics, What challenges have you faced after venturing into Molecular diagnostics?

Molbio Diagnostics was set up in the year 2,000 and after rigorous research of about 12 years, we finally launched the first prototype of ‘Truenat’ machine in the market.

We gave out these prototypes to key industry leaders for their opinions and we got very positive feedback, but as the prototype required some advancements, it was only in 2017 that we came up with the point-of-care solution of Truenat technology that we are now using. 

In this journey the first challenge was money, and we spent a lot of it, our R&D alone amounted close to Rs 400 crores till the time we went commercial, and we sourced it from small loans from DBT (Department of Biotechnology) and CSR (Corporate Social Responsibilility) as we did not get any funding or grants from anywhere.

It was a tough and long time for us, as we kept asking ourselves are we really making strides in the right way or not, but we risked it and stayed committed to the cause and then we reached everywhere in no time. As we knew there was a big gap in diagnostics delivery for various diseases, tuberculosis was one such disease and we developed our first test for TB only. 

Now with the technology in hand, the second challenge that we faced was ‘trust’, it was a big challenge to convince stakeholders as nobody would believe us that an Indian diagnostic solution can deliver such results. And credibility became a big issue for us not only in India but globally. So, it took a lot of convincing but eventually they came around after seeing the data and the impact of the solution. 

Then the government validated us for TB and WHO (World Health Organization) endorsed us in January 2020, based on this the central government placed a large order of 1,500 machines and 60 lakh tests for its TB elimination program.

What went on during the pandemic, and how did the company grow during the period?

We have a very strong R&D team, our team already knew there was something like Covid that has come up in China and by January our team was already working on a test, come March we had a validated test by ICMR (Indian Council of Medical Research). 

So by the time Covid hit India, we were ready as we had already supplied about over a thousand machines to the government for the TB programme, and the machines deployed for TB were repurposed for Covid. For the first 8-9 months we were the only major supplier for Covid tests in India.

Before Truenat, only NIV (National Institute of Virology) was doing Covid tests in India and after Truenat’s approval overnight there were thousand plus centres doing the testing. Further, we sold another thousand machines to state governments in the very first wave of Covid itself and we ramped up our manufacturing and tried to meet the demand.

But now we are back to being focussed on TB as the government is also expanding their TB programs due to the piling of TB cases in India.

What is the price of the Truenat machine and where are you selling it more?

The average price of the Truenat machine is about 10 lacs, at this point in time our larger deployment is in India, as in the last two years there was an export restriction due to Covid which prevented us from going global in that period, the global deployments have just started again from past six months.

In India, we have about 5,000 machines deployed in both public and private facilities, whereas we have over 1,000 machines deployed globally. As we go along we expect the global business to be greater than the domestic sales.

How and why do you think Truenat technology will change the game in the fight against TB?

The reason we were not able to eradicate TB till now given the government’s free drugs and diagnosis was due to the diagnostics they were using and they are still using which is called smear microscopy. 

Smear microscopy is only 40-50 per cent sensitive to TB, meaning if 100 people with TB show up, the machine will only detect 40-50 people. As per a study it takes about three years to diagnose a person with TB in India and every year that person gives TB to 17-20 people. 

Here, the Truenat technology has begun changing the game, it is rolled out in close to 3,000 microscopic centres as of today under the government’s National Tuberculosis Elimination Programme (NTEP), and these centres are using the platform as a first test.

And the government is planning to expand it to about 8,500 centres in the next 2-3 years, which makes it one machine in every block, making possible early diagnosis and up to 95 per cent of population coverage.

We are also providing the platform to 9 other TB-burdened countries that are using Truenat in their elimination programs in Africa and Asia. By next year, this number is set to increase to 28 countries. 

Prime Minister Modi has set the target of 2025 to eliminate TB from India, What is your opinion on putting a timeline for TB elimination?

It is very difficult to put a timeline on TB as its a multifaceted disease, there are presumptive cases which come in the centres but there are also asymptomatic cases which need to be factored in, the government has now started tracking this with Active Case Finding, by screening door to door in the hotspot areas.

But still, more efforts are needed and the active case finding needs to be further intensified, and focus also needs to be put on latent TB as elimination will not be possible without factoring in latent TB, So all this needs to be considered and I believe by 2025 we will have all the enabling mechanisms in place to start the actual fight towards eliminating TB from India.

Are you seeking any approvals currently for instance the USFDA nod for Truenat?

Currently, we have a WHO-endorsed TB test, and WHO has now started a prequalification process, so all the endorsed kits have to go through the process, we are also starting prequalification for other diseases such as HPV, Hepatitis C, and for HIV etc. WHO endorsement for these diseases helps developing countries to utilise public sector spending. 

And all our products are CE (safety mark for EU countries) marked but these also need to be reapproved as per the new EU IVDR (In Vitro Diagnostic Medical Devices Regulation) guidelines. And we also have plans to get the MDSAP (Medical Device Single Audit Program) nod by February next year, so this year we are doing all these, and USFDA will be done sometime next year.

How has the arrival of investment from Temasek helped Molbio?

Temasek coming in opens more global doors for us, we are already present in about 40 countries, but we want to expand this quickly and since Temasek is a global name, it will only add to our credibility more. 

We are expecting Temasek to play a positive role in taking our product to the corners of the world much faster than what we are doing now. Temasek came in as some old individual investors wanted an exit, now between Temasek and Motilal Oswal Private Equity there is a 20 per cent shareholding.

What are your future plans for Molbio, and where do you see the company in the coming years?

We definitely see ourselves as a very dominant player globally in coming years, as we are the only player in the world with this technology currently with 35 different tests that we can do on the same platform. And another 30 tests  will be added in the next two years,  so yes, we believe that within next 3-4 years we will be a dominant player in the point of care diagnostics market.

Right now its Truenat but we are already working on a platform that can do panel testing, for instance, if one wants to do a fever panel, the patient can have dengue, malaria, typhoid or any other disease, all these can be tested on a single panel and the patient need not be tested for each disease separately.

Similarly, we are working on a respiratory panel for infectious diseases and viruses. This technology is already developed and we plan to launch it sometime next year as currently we are waiting for validations and licensing.