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‘Eyeing to be a major player in the global molecular diagnostics market’ – ET HealthWorld

'Eyeing to be a major player in the global molecular diagnostics market'Sriram Natarajan, Founder, Director and CEO, Molbio Diagnostics, elucidates on how the outbreak of COVID-19 has accelerated the subject of molecular diagnostics. Truenat RT- PCR is predicted to grow to be extra of a routine medical diagnostics software not just for COVID, however for a wide selection of infectious ailments in the close to future in an interview with ETHealthworld’s Prathiba Raju.

Can you elaborate on the essential function Truenat RT- PCR is making in COVID-19 prognosis? Have you scaled it up particularly for the virus ?

The outbreak of COVID-19 dramatically elevated the want for RT-PCR exams that has resulted in the market measurement immediately rising many folds. However, there was restricted capability out there in the early levels for conducting RT PCR exams and Truenat was the solely platform that might allow RT-PCR testing throughout the nation. Also, our Truenat check for COVID-19 was amongst the early exams to be permitted by ICMR. While about 700 machines had been already out there in the non-public and public sector, the Union well being ministry determined to repurpose the 1512 machines that they had ordered underneath the TB program for COVID testing. Soon extra such machines had been ordered each by state governments and the non-public sector.

We have been working at the entrance of the pandemic from the starting and Truenat launched in 2013 has performed a vital function in India’s struggle towards COVID-19 by increasing entry to RT PCR testing in rural, useful resource-restricted geographies throughout the nation. It has additionally been the largest single model in the COVID testing house in India.

Today, greater than 4000 Truenat machines are getting used throughout the non-public and public sector for COVID-19, TB, hepatitis, H1N1 and different ailments testing throughout India.

Looking at the rising global demand for level -of-care molecular testing, we launched a new manufacturing facility in Goa this 12 months. The manufacturing capability has been elevated 5 fold, from the present 70,000 exams per day to over 3.5 lakh exams per day that can guarantee the uninterrupted availability of Truenat check kits each in the home and global markets for COVID and a number of ailments..

In the infectious illness house what sort of adjustments does Truenat RT-PCR convey in for the previous a number of years? How had been these studying used in COVID-19?

Truenat the progressive Real-Time PCR platform designed and developed as a fast, level of care answer for testing a number of ailments can be deployed throughout the healthcare chain proper upto the main degree. The machines are moveable, battery operated with wi-fi knowledge switch functionality and the kits are prepared to use and steady at ambient temperatures. This allows gold commonplace exams comparable to RT-PCR to be carried out at any setting with out the want for laboratory infrastructure.

In tuberculosis prognosis, after getting WHO and ICMR endorsements Truenat is now rolled out by the National TB Elimination Program in over 1500 microscopy centres; it’s getting used as the entrance-line screening check with DST, proper at the first level of affected person contact. Previously the Andhra Pradesh authorities had rolled out this check in 225 centres. It allows decentralized testing and creates common entry to prime quality diagnostics.

The identical learnings have been utilized for COVID testing the place the machines are used in very distant places comparable to Ladakh, Kargil, Spiti, Andaman Nicobar, Lakshadweep, North East states. An analogous strategy is being taken by the hepatitis and vector borne ailments management program.

With limitations of standard molecular platforms, what innovation was made to change the standard RT-PCR expertise into a level of care answer ?

Understanding the limitations of standard molecular platforms, we had to utterly re-engineer the standard RT-PCR expertise into a level of care answer by leveraging on applied sciences comparable to Micro Electro Mechanical Systems (MEMS), micro and meso fluidic cartridges, nanotechnology, low energy thermal biking utilizing disposable clever ceramic chips, lyophilization and different drying strategies and particular sealing strategies. The platform was made rugged by minimizing transferring elements, miniaturized to occupy little ground house, enabled for portability and battery operation, with on board reminiscence, touchscreen interface and wi-fi knowledge switch functionality and the reagents had been designed for single testing functionality, prepared to use and steady at room temperature (up to 30C) for 2 years. The clever chip carries a lot of knowledge and commonplace curve values for producing quantitative outcomes. The clever chip additionally ensures that fallacious chips, beforehand run chips and expired chips usually are not run.

The system requires no particular environmental circumstances, no particular upkeep or calibration necessities, has inbuilt diagnostic options and error reporting options.

How many exams are completed for infectious ailments, do you may have plans to launch extra in this house?

Truenat exams are already out there for over 28 infectious ailments whereas exams for an additional 30 new ailments are in growth that are anticipated to be launched over the subsequent two years. A spread of open format reagents by the identify Truemix are additionally deliberate once more in prepared to use, room temperature steady format.

We know that you simply put together testing kits for infectious illness, are you able to inform us does how these testing kits for zika, cholera, nipah, sickle cell anaemia, cholera, influenza, mumps, syphillis, yellow fever, HIV2 differ from one another or it stays the identical?

The platform has been designed to broadly stay the identical. All the assays work on the precept of Real Time Polymerase Chain Reaction (RT-PCR) primarily based on taqman chemistry. All these are primarily based on disposable, room temperature steady, chips and fluidic cartridges. The distinction is in the composition of freeze dried PCR reagents offered in the microtube that’s assay particular. The clever chip additionally carries illness particular check and batch associated data together with commonplace values for quantitation which are entered throughout the manufacturing course of.

How the molecular diagnostics which remained an underserved section in the Indian state of affairs for a very very long time is now modified due to the pandemic. Although RTPCR was invented a number of many years in the past and has now gained momentum? How are you going to carry ahead this chance?

Molecular diagnostics was an underserved section in the Indian diagnostics state of affairs for a very very long time regardless of being considered the most dependable for infectious ailments testing, particularly RTPCR that was invented a number of many years in the past and is taken into account the gold commonplace for diagnosing many ailments. The main motive for this was due to the extremely centralized nature of molecular diagnostic platforms needing excessive ranges of laboratory infrastructure and ability dependence, excessive capex and opex prices, the want for batch testing, logistics problems with pattern transportation and the consequent lengthy turnaround time for outcomes. Hence, these exams by no means turned routine medical diagnostic instruments and their utilization was additionally restricted to confirmatory testing, out there at solely a few centralized laboratories and hospitals in major Indian cities.

The outbreak of COVID-19 dramatically elevated the want for RTPCR exams that has resulted in the market measurement immediately rising many folds. This has considerably elevated the variety of labs doing molecular testing which resulted in enhanced manufacturing capability for such exams in the nation and the variety of gamers in the standard laboratory section.

With the rising consciousness, the demand for early prognosis of infectious ailments is excessive, and varied private and non-private organizations are investing funds to speed up R&D in the subject of molecular diagnostics. Recently, the infectious illness software section accounted for the largest market share and can develop in the coming years. As per Research and Market report– the Indian molecular diagnostics market stood at an estimated USD$ 920 million in FY 2020 and is projected to develop at a CAGR of round 10% till FY 2026, predominantly on account of rising circumstances of deadly and continual ailments.

The rising prevalence of infectious ailments comparable to tuberculosis, hepatitis B, and hepatitis C, coupled with exams for sexually transmitted ailments/infections like HIV and HPV will propel the section’s development. Molecular testing is predicted to grow to be extra of a routine medical diagnostics software not just for COVID however for a wide selection of infectious ailments in the close to future.

Over the previous few years it has quickly scaled up throughout the nation due to its capability to be deployed in any respect ranges of the healthcare chain together with PHCs and CHCs thus decentralizing molecular testing and democratizing entry to excessive ended, impactful instruments at the first level of affected person contact.

Where do you see your self in the molecular diagnostic house in the subsequent 5 years?

Truenat is already being seen as a multi-illness platform and in addition to the TB program, we count on different applications comparable to the viral hepatitis program, NACO and vector borne ailments program to add to the wider deployment and utilization of the expertise at the grass root degree. The Indian non-public sector can be ready to use the Truenat platform for delivering prime quality diagnostics for the full vary of exams out there.

There can be a a lot bigger and rising global demand for top of the range molecular diagnostic instruments that may be particularly deployed at the level of care. We count on to set up ourselves as a major player in the global molecular diagnostics market in the coming years. At the identical time we’re additionally engaged on different level of care applied sciences for offering higher options for antimicrobial resistance and non-infectious illness testing functions.

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