Molecular diagnostics platform for fast and point-of-care disease diagnosis

Molecular diagnostics is known to have superior advantages for routine detection of infectious diseases and now has a very prominent place in clinical laboratories. Based on the principle of DNA/RNA amplification, molecular diagnostic techniques help in early diagnosis of infectious diseases, providing the added edge of excellent sensitivity and specificity. However, this technique has, thus far, been limited to centralized laboratories due to dependency on complex and expensive infrastructure, highly skilled manpower, special storage conditions and a need for batch testing. This results in high turn-around time and poses major logistics challenges, such as sample degradation, contamination, report delays, etc.
Molbio Diagnostics Pvt Ltd has developed and commercialized Truelab™, a commercial point-of-care (POC) molecular diagnostics platform that uses PCR technology with Truenat test chips. Truenat™ disease-specific test chips are available for the diagnosis of 22 infectious diseases (such as TB, H1N1, dengue, HIV, hepatitis, etc) and an additional 43 diseases (such as coronavirus, MERS, etc) are in the pipeline.
The Truelab™ platform, a global first, is a compact, battery-operated system, with single testing capability and provides sample-toresult times within 1 hour. Hence, it enables same-day reporting and initiation of evidencebased treatment for the patient. Doctors benefit from this technology by having a definitive diagnosis, early in the infection cycle, without patients/samples having to travel extensively to centralized facilities.
The Truenat™ assay is rapid and affordable with minimal infrastructure requirements. Thus, placing the Truelab™ multi-disease detection system in the most remote settings will enable mass access to advanced molecular testing for people of all socio-economic backgrounds, across the globe. The device has real-time data transfer capability (through SMS/email) for immediate reporting of results in emergency cases. Additionally, a cloud-based centralized data monitoring and surveillance network can be created and linked to all devices in a region. Complete data from tests performed can be accessed, analysed and recorded in real time. Such same-day reporting of results will strengthen the healthcare systems across countries by improving effectiveness of providing treatment and quarantining of patients, thus controlling spread of communicable diseases. The device is ideal for places that do not get regular electricity, and will work well even in primary healthcare centres, unlike other devices that require uninterrupted power supply, elaborate infrastructure and air-conditioning.
Molbio’s technology has been approved by the Indian Council of Medical Research in 2018, after 3 years of validation study across various sites in India. Internationally, the World Health Organization (WHO), after conducting a multicountry study, has released a rapid communication in January 2020 endorsing Truenat™ as an initial diagnostic test of Mycobacterium tuberculosis (MTB) and MTB-RIF (MTB rifampicin resistance) in view of its high diagnostic accuracy. The WHO has further endorsed Truenat™ for diagnosis of TB as a replacement of the less sensitive sputum smear microscopy. The performance of Truenat™ shows comparable accuracy with other WHO approved tests such as Genexpert, TB-LAMP® and line probe assay. Truenat™ will help in decentralizing and democratizing access to high quality diagnostics to millions of patients suffering from TB and other infectious diseases even at peripheral and remote settings.
At present, Truelab™ devices are installed in over 500 private laboratories, 350 government primary health centres in India and in 27 countries around the globe, extending across the continents of Asia, Africa, Europe and South America. WHO endorsement will further enable the product to be commercialized across more than 150 countries.
Truelab™ is patented across over 100 countries which enables the transition from presumptive to efficient, real-time and precise diagnosis of multiple diseases at reasonable price even in primary healthcare centres and smaller diagnostics labs, which can now deliver high-end molecular diagnostic tests.
Molbio Diagnostics is driven by the urgent need to provide world-class medical devices to enable better medicine through precise, faster, cost effective diagnosis and envisions to be a leading global player in the POC diagnostics segment by continuing to innovate and bring new technologies for social betterment.
In addition, given the current coronavirus pandemic, Molbio is pleased to announce that the Truenat™ Beta-CoV POC RT-PCR test is currently being validated through a regulatory process and is expected to be commercially available in the next couple of weeks. This rapid, portable, POC solution will enable molecular testing for COVID-19 to be performed even at the community level and will provide results within 1 hour from sampling.

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