Taking diagnostics to people’s doorstep

PCR or polymerase chain reaction test became a household name during Covid-19, as lakhs scrambled to get themselves checked for the then dreaded virus that was killing people in a matter of days. And the people behind PCR, bringing the test virtually to the doorstep not only in big cities but also across the vast hinterland were two scientists, Sriram Natarajan and Chandrasekhar Nair, who had spent years working in the field of diagnostics developing a product based on the technology that could be used at the point of care to revolutionise disease detection.

Working independently in their earlier years, the two scientists came together in 2009 and that was the start of the collaborative journey that led to the launch of Truenat, a chip-based, point-of-care rapid molecular test for infectious vector borne diseases. In simple terms, what the product did is take diagnostics — testing for diseases — out of the lab environment and made it accessible to people and at places where such facilities were not available. Since it is based on molecular technology, instead of microscopy, it is several times more sensitive and has the capability to detect diseases at an early stage, increasing the chances of full recovery.

The diagnostics platform is delivered through rechargeable battery-operated devices at room temperature with ready-to-use reagents. While it has the capability to test over 40 diseases, where it is clearly making a difference is in screening for the dreaded tuberculosis; India accounts for a fifth of all cases across the world.

Currently, the company makes over 10,000 devices a year and over three lakh tests are done a day.

The scientists

Sriram Natarajan, who left his PhD in Botany at Delhi University midway to join Hoechst (now Sanofi) because he wanted to be in healthcare, founded Molbio Diagnostics in 2000 after doing considerable work in the field. He first venture was Tulips Diagnostics in 1990, which offered rapid diagnostic tests for vector borne diseases not only in India but globally.

Consumed with the passion to do something in the field of healthcare that would create a social impact, Natarajan left Hoechst and teamed up with two partners to set up a diagnostic company that would make products for low- and middle-income countries. “It was at Tulip that we could realise the dreams we had,” he says. “Tulip was set up to be a completely Indian company, looking at problems to solve in diagnostics and providing solutions.”

Tulip was set up in Goa due to locational advantages as well as the assistance the administration extended to him when he was looking for a place to set up a manufacturing unit.

The company grew organically to become the largest provider of diagnostics services in India and overseas. “From Day 1, we were clear that we’ll keep the quality levels high, and we’ll also export.” The company offered rapid diagnostic testing (RDT) for malaria, a technology that was not available in India then. “For malaria, we were the only company in the world to have this test for a very long time. For 10-12 years, the company had a 60 per cent market share, initially starting with the less sensitive microscopy and then replacing that with RDT.” The testing was expanded to other diseases as well.

But Natarajan was not satisfied. His intent was to make testing for diseases laboratory-independent and take it closer to the people, with faster and better outcomes. While Tulip’s rapid tests were a step in that direction, he wanted to take it to the next level. With that aim, he set up Molbio Diagnostics that would focus on molecular diagnosis.

“We wanted to get into molecular diagnosis because we knew that was where the future lay.” Immunodiagnostics, while good for a lot of applications, had several limitations such as occurrence of false-positives, insensitivity, and lack of specificity.

Molbio was to be Natarajan’s solution that would take diagnostics close to 100 per cent reliability. “And the only thing that could do that was molecular testing or real time PCR which is, even today, considered the gold standard of testing.”

At that time except for some large diagnostic chains and government institutions, no one else was doing real-time PCR and even in those cases it was mostly used for referrals or as a confirmatory test and not as a routine clinical tool. Natarajan was looking for a technology that could be taken to low-income communities and remote places.

Then he met Chandrasekhar Nair.

Nair, who had a degree in chemical engineering and a background in lifesciences, had started Bigtec Labs in 2000, along with three others who had an IT background. They were fired with the zeal “to do something very interesting in emerging technologies”. They zeroed in on diagnostics where they could put their expertise to work, as he says, “considering that all of us fall ill all the time and most of us are treated empirically.” As a researcher he had worked on PCR and thought that was an interesting tool that could be probed further. “In sensing technology, either something is very sensitive, or something is very specific. Seldom do the two meet. But in PCR, we found a beautiful confluence of sensitivity and specificity so much so that even if you have one organism, you should be able to pick it out,” says Nair.

At that time, diagnostics was available for tertiary care and a little in secondary care, but scarce in primary care, where it is most needed. Nair was scouting for a technology that would enable physicians treat based on evidence rather than just empirically; though there were a lot of research papers on subject — PCR-on-chip-— there were few products available for use at the point of care.

Fortuitous meeting

Nair and his partners experimented with several materials to create a chip that could be a receptacle for the PCR test. They found that low-temperature co-fired ceramics had the right properties. They made a crude chip out of that and were able to get a soft loan from the New Millennium India Technology Leadership Initiative programme, the R&D arm of the Council of Scientific and Industrial Research. They also got to work with some of the leading scientists in the country such as Govindrajan Padmanabhan, who was the Director of the Indian Institute of Science; and Nirmal Ganguly, former Director-General of the Indian Council of Medical Research. Working at IISc, they were able to come up with the first version of the PCR-on-chip which they were asked to run on clinical samples. In 2008, they started testing for Hepatitis B viral load and then the next year when swine flu broke out, they were able to put it to test and detect the virus in less than an hour.

The platform was garnering a lot of attention and ICMR was looking to validate it. But Nair had a problem: How to commercialise the technology. He started talks with some international companies, either to sell the technology or collaborate because his main objective was that it should reach the people for whom it was intended.

At this juncture his meeting with Natarajan proved fortuitous. The two met at a conference in Delhi where Nair was presenting a paper on the Truenat concept and real-time PCR.

“Here was a person who had already scaled diagnostics globally through Tulip and he understood international and India regulations, he understood manufacturing and how to deal with the people concerned. So, we decided to work together,” says Nair.

As for Natarajan, “I was bowled over. I thought, this is exactly what I am working towards.” The two companies, Molbio and Bigtec, formed an equal joint venture in 2012 and later in 2015, they merged. Tulip Diagnostics was sold in 2017 to Perkin Elmer. The first semi-automatic PCR device, ‘Truelab Uno’, was launched in 2013 and the fully automated version in 2018. It was approved by the ICMR and in 2020 the World Health Organisation endorsed Truenat as the initial diagnostic test for MTB (mycobacterium tuberculosis) and MTB-RIF (resistance to rifampicin).

With all this in place and a huge government order to deliver over 1,500 machines and several million TB tests to follow, Covid struck. All the resources of the company, all the machines it had deployed were diverted towards testing for Covid. Though the company did not have the capacity to cater to the kind of demand the pandemic raised, it put all its efforts into meeting it. “We pushed ourselves,” recalls Natarajan. “There was no one else who could administer the Covid test at that time.” The company’s turnover zoomed from Rs. 50 crore to Rs. 1,300 crore within a year. Covid forced the company as well as government agencies to scale up their facilities. It proved to be a turning point in primary healthcare and gave a boost to diagnostics in the country.

Once the pandemic died down, Molbio turned to what it had originally set out to do. “It is saving lives. We are creating a huge impact in diagnosing TB in India and other countries. Case detection of TB has doubled from what it was earlier simply because the microscopy technology was only 50 per cent successful,” says Natarajan. “As we go along, this process, we will see TB spread coming down.”

Molbio is working on more technologies and platforms to bring diagnostics to other areas as well with point of care being the focus. These include early detection of TB through X-ray devices, breast cancer screening through thermal imaging, screening for cervical cancer, and routine blood tests. The key idea is to decentralise pathology and diagnostics and take it right to the doorstep of people, where labs and facilities are not available.

The tests are also cost-effective, being delivered at a fraction of the price available elsewhere. For instance, the PCR test for Hepatitis B was launched at Rs. 1,000, compared to Rs. 7,000 with microscopy.

Global Recognition and Funding

The endorsement by WHO in 2020 opened up opportunities for collaboration and financial support for the diagnostics company. In the same year Motilal Oswal Private Equity infused Rs. 240 crore while in 2022 Singapore’s Temasek invested $85 million valuing it at $1.6 billion and putting it in the unicorn category.

In 2023, The Global Fund (to Fight AIDS, Tuberculosis and Malaria), the USAID and the Stop TB Partnership announced a collaboration with Molbio to reduce the prices of its TB tests, including a supply of MTB-RIF Dx tests for subsequent testing for rifampicin resistance.

Molbio is also working on a public listing of shares via an initial public offer that will most likely be an offer for sale for its early investors.

For Nair, Natarajan, and the team at Molbio, the satisfaction as well as their inspiration lie in the fact the work they are doing is creating a perceptible impact in saving lives. For instance, in the case of Nipah virus, there was tangible evidence that these tests could work very well.

“In the Indian and global healthcare system, at the primary level, we believe that there is a responsibility on us to work on many neglected diseases that allows very quick decisions to be taken and therefore prevents the spread,” is Nair’s pragmatic but visionary view.