“Truenat platform has proven itself as a breakthrough diagnostic tech for TB”

Molbio’s Truenat platform is designed for the rapid diagnosis of infectious diseases. It is portable, battery-operated, wireless data transfer capable and delivers results quickly, making it ideal for use in remote settings. This technology ensures early detection and timely medical intervention, even in areas with limited access to traditional laboratory services.

In an exclusive interview, Sriram Natarajan, Chief Executive Officer, Molbio Diagnostics shares his insights on the company’s contribution in eradicating tuberculosis, its unique product portfolio, and future outlook.

How is Molbio playing a role in advancing precise, rapid and cost-effective point-of-care diagnostics?

Molbio Diagnostics is an innovative Indian In-Vitro Diagnostics (IVD) company which aims to decentralize and democratize access to high quality diagnostics across the world through novel, near patient and point of care solutions. We have launched the widely acclaimed ‘Truenat Real-Time PCR’ – the world’s first point of care Real Time PCR platform for diagnosis of a wide range of infectious diseases in 2013. It is the first such platform to be commercialized that has enabled even highly resource limited settings such as Primary and community Health Centers to conduct sophisticated molecular diagnostics as the frontline test for multiple diseases thus bringing in a paradigm shift to disease control and management and creating a huge impact on patient and societal well-being.

Over the past few years Truenat has been rapidly scaled up across the country because of its ability to be deployed at all levels of the healthcare chain including PHCs and CHCs thus decentralizing molecular testing and democratizing access to high ended, impactful tools at the first point of patient contact. Molbio offers a ‘global first’ platform that can perform Molecular Diagnostics for infectious diseases at the point-of-care – Truelab Real Time Quantitative micro–PCR System. This compact battery-operated system has single testing capability and provides sample to result within 1 hour. Hence, it enables same day reporting and initiation of evidence-based treatment for the patient. It also has real-time data transfer capability (through SMS/E-mail/data push) for immediate reporting of results in emergency cases.

With a large and growing menu of assays for infectious diseases, this rapid, portable technology enables early and accurate diagnosis and initiation of correct treatment right at the first point of contact. The platform is infrastructure independent and provides a complete end to end solution for disease diagnosis. With proven ability to work even at Primary Health Centres and with wireless data transfer capability, this game changing technology brings in a paradigm shift to the global fight in control and management of devastating infectious diseases.

“Molbio’s Truenat has achieved remarkable progress in global healthcare, conducting 400,000 tests daily across 10,000 installations worldwide.”

How Molbio is contributing to eradicating TB in India?

Molbio’s Truenat has achieved remarkable progress in global healthcare, conducting 400,000 tests daily across 10,000 installations worldwide. This extensive network guarantees that Molbio’s technology reaches even the most remote areas, providing access to high-quality healthcare services. Upholding the ethos of “Make In India,” Truenat remains the sole WHO-approved and recommended point-of-care decentralized molecular test for tuberculosis globally. It has been implemented in primary care facilities across more than 80 countries. Consequently, governments in nations with a high burden of tuberculosis can acquire Truenat through the Global Drug Facility, hosted by the United Nations-OPS and the Stop TB Partnership. As per the TB Reports of India for 2022 and 2023, Truenat is the most prevalent molecular test for suspected tuberculosis cases.

In 2022, over 3.48 million individuals were screened using 3,615 Truenat machines, leading to the diagnosis of more than 529,000 cases of active tuberculosis and 25,000 cases of drug-resistant tuberculosis. In 2021, 2.2 million individuals were screened, with over 450,000 diagnosed with active tuberculosis and 21,927 with drug-resistant strains. Additionally, Truenat is integrated into the national viral hepatitis control program and the vector-borne disease control initiative of the Indian Ministry of Health and Family Welfare. India has distinguished itself in pandemic preparedness, having nearly 2,000 Truenat machines already in operation as part of the national TB elimination strategy prior to the WHO’s declaration of COVID-19 as a public health emergency. This existing infrastructure was swiftly adapted to facilitate COVID-19 diagnosis through the ICMR-validated Truenat RTPCR test.

How has the Truenat platform proven itself as a breakthrough diagnostic technology platform for Tuberculosis (TB) and 28 other infectious diseases?

The Truenat platform has proven itself as a breakthrough diagnostic technology for Tuberculosis (TB) and 40 other infectious diseases through several key features. It allows for molecular diagnostics to be conducted directly at the point of care, eliminating the need for centralized laboratory facilities. This increases accessibility to accurate and timely testing, especially in remote or resource-limited areas. The platform’s compact, battery-operated design makes it highly portable, enabling healthcare providers to perform diagnostics in a variety of settings, including mobile clinics and field locations.

Truenat provides results within one hour, allowing for same-day reporting. This rapid turnaround is critical for timely initiation of treatment, especially for diseases like TB, where early intervention can significantly improve patient outcomes.  Truenat has been validated and endorsed by reputable organizations like the Indian Council of Medical Research (ICMR) and the World Health Organization (WHO) as a frontline test for TB. This endorsement underscores the platform’s reliability and accuracy.

The platform’s ability to transmit results in real-time via SMS or email facilitates immediate decision-making, particularly in emergency cases where rapid response is crucial. Beyond TB, Truenat is capable of diagnosing 28 other infectious diseases, including Dengue, Chikungunya, H1N1, and Hepatitis. Its adaptability to multiple pathogens makes it a valuable tool in managing various infectious disease outbreaks. By providing rapid and accurate diagnostics, Truenat helps reduce the burden on overburdened healthcare centers, enabling a more efficient distribution of workload and resources.

“In India, the adoption of PoC diagnostics has been steadily increasing, as it offers numerous benefits such as rapid results, cost-effectiveness, and convenience.”

How do you look at the future potential and key growth drivers of the Indian diagnostics industry?

In India, the adoption of PoC diagnostics has been steadily increasing, as it offers numerous benefits such as rapid results, cost-effectiveness, and convenience. While the benefits of point of care diagnostics are clear, there are also several challenges to implementing these technologies. One of the main challenges is ensuring the quality and accuracy of test results, particularly in settings where healthcare providers may have limited training or experience with these devices.

Another challenge is the cost of maintaining PoC devices. While these devices are generally more cost-effective than traditional lab testing, the initial investment and upkeep can be prohibitive for some healthcare facilities, especially in low-income areas. Finding ways to reduce costs without compromising quality is crucial for widespread adoption.

Having said that, I see that the future potential of PoC diagnostics in India is highly promising. With ongoing technological advancements, we can anticipate the introduction of more affordable and user-friendly devices, facilitating their adoption by healthcare providers. A notable example is Truenat, an indigenous innovation and the world’s first multi-disease PoC molecular diagnostic platform designed for diagnosing over 40 infectious diseases on the same platform. The Truenat is also WHO endorsed for diagnosing TB and drug resistance in TB suspects and adopted for use by national programs across the globe.

What is the company’s long-term vision?

Today, Molbio with a staff strength of about 700, is already the largest IVD company in India with over 10,000 installations in the public and private sector and spreading its wings globally with distribution in over 80 countries. Molbio aims to be a large global player in the molecular diagnostic segment in the coming years working with Governments, NGOs and the private sector.

*This interview was first published in the September 2024 issue of BioVoice e-magazine.