Truenat is today fulfilling the goal of being a multi-disease diagnostics platform. Currently more than 30 validated and regulatory approved assays are being run on the platform. In addition to TB, a wide range of bacterial pathogens and drug resistance, Covid19, the entire range of Hepatitis tests and multiple other tests for viral diseases, vector-borne diseases like Dengue, Chikungunya, Malaria and Scrub Typhus are currently being run on the Truenat platform across the country at both public and private healthcare settings. Truenat was also validated extensively by ICMR and FIND for Indian and WHO approvals for sensitive and rapid detection of MDR-TB.
In an exclusive conversation with the Financial Express Online, Chandrasekhar Nair, Co-Founder & Chief Technology Officer, Molbio Diagnostics talks about Truenat RT-PCR technology, R&D and market scenario in the country and diagnostics advancements for early detection of infectious diseases in the country. Excerpts:
Please tell us about the journey of R&D for Truenat tests.
Molbio Diagnostics is one of India’s leading healthcare companies in the In-Vitro Diagnostics (IVD) segment and the manufacturer of the molecular diagnostic platform Truenat Real-Time PCR. Molbio was at the front of the fight against Covid19 from the beginning and we believe that Truenat has played a significant role in India’s fight against Covid19 by expanding access to RTPCR testing in rural, resource-limited geographies across the country.
When Covid19 hit India, Molbio rapidly developed a test on the Truenat platform and after validation by Indian Council of Medical Research (ICMR), Union Health Ministry, was able to repurpose these devices to increase testing capacity pan India. This was followed by additional deployment by other state Governments and the Private sector.
A pipeline of more than 30 tests will ensure that newer tests are constantly available on the Truenat platform to address the existing and emerging healthcare challenges faced worldwide.
A range of open format ready to use, room-temperature stable reagents under the Truemix brand are also being released, to enable high-quality testing on conventional RT PCR machines.
The genesis of the journey for Truenat was the desire of a group of like-minded professionals to build a rapid, sensitive and cost-effective device for infectious disease diagnosis at Point of Care that was independent of infrastructure (air-conditioned rooms, cold storage facilities, continuous and conditioned power), required minimal training, created the ability to diagnose and initiate precise treatment in a single visit, was cost-effective and could leverage mobile technology that could be used to identify disease hotspots
The team at bigtec labs (the R&D subsidiary of Molbio) was responsible for the ideation, translation and initial validation of the platform supported by Government of India agencies like NMITLI (CSIR), BIPP (DBT) and ICMR. It took Molbio and Bigtec almost two decades of research, development, national and international validation, establishing custom built automated, state of the art manufacturing facilities at scale and commercialization efforts to make Truenat the world’s first and only truly point of care, multi-disease capable Real-Time PCR platform that is infrastructure independent. Truenat can be deployed with ease at primary health centers at remote locations as well as at an urban multispeciality hospital to provide quick and reliable diagnosis.
To meet the design goals, the platform had to be engineered ground up leveraging technologies like Micro Electromechanical Systems (MEMS), micro and meso fluidics, and material science including nanomaterials.
The platform was ruggedized by minimizing moving parts, miniaturized for portability and battery operation, onboard compute and storage capability, built-in intelligence, a touchscreen interface, and wireless data transfer capability to minimize operator skill and reagents stable at room temperature for up to two years to minimize infrastructure dependence.
Do you think with the invention of Truenat technology we will be able to control the impact of COVID-19 and the Nipah virus?
Rapid and accurate diagnosis enables a rapid return to wellness for the patient and control of spread of infections for public health. The availability of Truenat at distributed locations across the country enables the healthcare ecosystem to respond rapidly to emerging infections like Nipah by providing reliable diagnosis on demand and at the first point of contact. This allows appropriate treatment to be initiated early, leading to a better patient outcome as well as preventing spread of the disease.
Truenat has played a significant role in India’s fight against COVID-19 by expanding access to RTPCR testing across the country. More than 4000 Truenat machines are being used across testing sites both in the private and public sector for COVID-19 testing all over India.
What is your opinion on viruses which might come up in the future, and if it does, would you think of developing tests for the same like you have developed for Covid right now?
We are constantly working to ensure the development of tests for emerging diseases that have an unmet need. An example is our collaboration with NIV to develop a test for Kyasanur Forest Disease as we did for Nipah.
How many Nipah tests can be done on one machine? How long does it take to share the results?
The Truelab real time micro PCR analyzer is available in 3 variants – Uno Dx, Duo, and Quattro that can perform 1, 2, and 4 tests at a time, respectively. It takes approximately an hour from the sample to the result. All devices are capable of running nonstop round the clock and have been used thus during the peak of the Covid19 pandemic.
How is the Truenat platform unique from all of its competitors?
Truenat is the only commercially available multi-disease capable Point of Care Real-Time PCR platform that can be deployed independent of the infrastructure available worldwide. With a turnaround time of 60 minutes from sample to result, Truenat ensures early and accurate diagnosis and appropriate initiation of treatment on the same day of presentation. This not only helps better patient outcomes but also prevents further spread of the disease.
The portable, battery-operated, rugged devices, ready-to-use room temperature stable reagents, and the fully automated protocols ensure that testing can be done by minimally trained technicians. In-built data transfer capability further enables remote interventions and remote monitoring. This brings in a paradigm shift in diagnosing diseases by binging high end molecular testing to the remotest corners of the world and enabling it as the first line test for various diseases.