What have been the learnings for your company during the Covid-19 pandemic when testing was the starting point of the diagnosis?

The sheer magnitude and unchecked spread of Covid-19 and the devastation caused by the pandemic glaringly exposed the unpreparedness and inadequacies of our health care system.

The capacity for RTPCR testing as a starting point for disease control and management was negligible and even the little capacity available was highly centralized to a few big laboratories.

Molbio has pioneered point of care molecular testing through its novel Truenat Real Time PCR platform with the prime objective of decentralizing and democratizing access to this gold standard technology and enabling early and high-quality testing at the point of first patient contact.

Molbio’s Truenat test for Covid-19 was among the early tests to be approved by ICMR. While about 700 machines were already available in the private and public sector, the Ministry of Health and Family welfare decided to repurpose the 1512 machines they had ordered under the TB program for Covid testing. Soon more Truenat machines were ordered both by state governments and the private sector.

Today, more than 4000 Truenat machines are being used across the private and public sector for Covid-19, TB, hepatitis, H1N1 and other disease testing all over India.

Looking at the growing global demand for point of care molecular testing, Molbio Diagnostics launched a new manufacturing facility in Goa in June 2021. The manufacturing capacity has been increased 5-fold, from the existing 70,000 tests per day to over 3.5 Lakh tests per day that will ensure the uninterrupted availability of Truenat test kits both in the domestic and global markets for Covid and multiple diseases.

During the pandemic, the emphasis was on Covid-19 testing and other screenings took a back seat. What’s the situation today?

The neglect of other diseases testing during the Covid-19 pandemic is already visible by a steep increase in the prevalence of other diseases such as TB, Hepatitis, H1N1, Dengue, etc. In the case of TB, there has been a significant erosion in the gains made during the past years and the caseload has increased substantially.

All these programs are now getting back to their implementation activities and testing for other diseases is increasing in both the public and private sectors.

The growing health awareness and the global push for the elimination of diseases such as TB, Malaria, HIV, Hepatitis etc. are further driving the testing demand.

How has the Truenat platform changed the nature of testing in India? What’s the demand for your product in India and overseas markets?

Truenat has played a significant role in India’s fight against Covid-19 by expanding access to RTPCR testing in rural, resource-limited geographies across the country.

Truenat is globally the only point-of-care RTPCR system that decentralizes and expands access to the gold standard technique through its portable, battery-operated, user-friendly machines and ready-to-use room-temperature stable reagents. Having a single testing capability, the platform operates without the need for skilled manpower or laboratory infrastructure, returning results within one hour of sample collection. Hence, it enables same-day reporting of results and initiation of evidence-based treatment for the patient. It also has in-built wireless data transfer capability (through Wifi/GSM/Bluetooth) for providing telemedicine services and real-time disease monitoring and surveillance. With proven ability to be deployed at remote, resource-limited settings, this platform enables timely and reliable diagnostics at the first point of patient contact.

More than 4000 Truenat machines are deployed in India between the public and private sector and over 1000 systems are in use in other countries.

Which markets have shown promise to incorporate Truenat as part of their testing protocol?

Truenat is now present in over 40 countries including Asia, Africa, the Middle East, Europe, Central, and South America, the Caribbean, Russia etc. Truenat is also deployed all over India.

What are the new features that you plan to add to Truenat in terms of diseases that can be detected?

Currently, the platform can test over 30 different diseases, such as Tuberculosis, Covid-19, Dengue, Chikungunya, H1N1, Hepatitis, HIV, Chlamydia, HPV etc. with tests for over 30 additional diseases in the pipeline.

 In September 2021 Drug Controller General of India (DCGI) authorised the Molbio Diagnostics Truenat platform for emergency use to test Nipah. This is the first kit in India to receive regulatory approval to conduct tests for Nipah. In October 2021, Molbio Diagnostics received (DCGI) approval for its Truenat Scrub T-test for Scrub Typhus.

Molbio is working towards addressing the critical need for reliable technologies that can enable early and accurate diagnosis of many more such critical viruses/diseases.

The government is proposing to regulate the diagnostics industry and to standardise it as they feel that there are too many products that would not stand scrutiny. What’s your view on the same?

 This is extremely important and a need of the hour. The new medical devices rules are already much more stringent and aligned with International regulations and further strengthening of the same and focus on implementation is essential to ensure the quality of diagnostic tests in the market.

How do you plan to address challenges emerging in rural settings where access to testing is an issue?

Molbio started with an aim to make a molecular testing platform that is truly free of all infrastructure. Today, it is one of our USPs: Anyone, Anytime, Anywhere. Truenat has successfully decentralized and democratized access to molecular diagnostics in India and the world.

Today Truenat system is already in use in over 2000 primary health centres across the country, with minimum infrastructure and we expect to add many more such centres to provide access in rural settings.

What are the plans for your company in terms of expansion? 

The company has just added over 5 times capacity through two new facilities, one in Goa and the other in Visakhapatnam. This translates to over 350000 tests per day that is a fairly large capacity keeping global ma