‘’Any business model for TB can be successful only if it can be deployed till the very bottom of the health care chain’’

Tell us about the inception of Molbio diagnostics.

Chandrasekhar Nair

Molbio Diagnostics is a joint venture (JV) company between Bigtec Labs and Tulip Group. Bigtec focuses on R&D infrastructure to develop indigenous market-ready innovative diagnostic tools specifically for countries like India where infectious diseases are prevalent and the health infrastructure is resource-limited, while, Tulip, a leader in the Indian diagnostics space, has the extensive manufacturing and marketing expertise since it caters to both to Indian and international markets. Molbio enables us to deliver the Truelab Real Time micro PCR System to the global markets in the most effective way.

Tell us something about the product, its technology and advantages vis-a-vis sputum smear test. Also, how does it rank on sensitivity, specificity, duration of the test, clinical outcomes, its ability to detect MDR TB, TB in children and extra pulmonary TB.

N Sriram

The Truelab Uno is a MEMS-based (Micro Electro-Mechanical Systems-based) real time micro Polymerase Chain Reaction (PCR) device. PCR is fast becoming the gold standard in infectious disease diagnosis since it’s very sensitive and specific. However, traditional PCR equipment is very expensive and inaccessible to the people most afflicted by infectious diseases since it requires extensive laboratory infrastructure and skilled operators. Truelab Uno is portable and battery operated, and is designed to be used by minimally skilled technicians. It also offers rapid detection time of 45-60 minutes.

We conducted a study with Hinduja Hospital, Mumbai, the results of which were published in PLoS One. It reveals that the test has a sensitivity greater than 99 per cent in sputum positive (S+), culture positive (C+) as well as a specificity of 100 per cent versus a composite reference standard (CRS). Not only this, it was also able to detect all strains on a panel from WHO/TDR that contains over 220 geographically diverse strains of tuberculosis (TB) in an evaluation done recently. While our current test does not detect drug resistance, we are working on a test that not only detects TB but also detects resistance to first line anti-TB medication like isoniazid and rifampicin. We are also in the process of designing studies to evaluate the test performance vis-a- vis TB in children and extra pulmonary TB.

When is Truelab expected to hit the market? What is it priced at? How much investment has been made so far?

Marketing will start from March 2013. The TB test would be priced between Rs 800 to Rs 1000 to the lab. The workstation comprising the Truelab analyser, Trueprep Mag device, printer and a set of pipettes will be priced at about Rs 4.5 lakhs, which is an one-time investment. We have spent close to Rs 50 crores on the development of technology and setting up manufacturing facilities.

Although the Revised National TB Control Programme (RNCTP) programme has achieved 100 per cent coverage, India’s TB burden is not showing any signs of improvement.

This is predominantly because of poor case detection owing to poor diagnosis of suspected TB patients. Two people die every three minutes in India due to mismanagement and misdiagnosis of TB patients. While mismanagement can and is being addressed to some extent by policy makers, misdiagnosis is largely due to the fact that the existing tests are not good enough and better tests are not available. The existing smear microscopy test, which is most prevalent, has a low sensitivity of 40 to 50 per cent which in turn means that it misses half of the positive cases. In the meantime, the patient is commonly treated with ineffective antibiotics, continues coughing and spreading the disease. Performing a culture for TB diagnosis, can take over a month, a huge disadvantage when it comes to diagnostics purposes. Hence, current diagnostic tools have been inadequate owing to poor sensitivity and specificity, poor deployability, high cost, long lead time from test to result and the need for specialised infrastructure and skilled man power.

Worldwide, India leads in providing access to ARVs and is the largest producer of generic TB drugs. TB diagnostics is one area where Indian companies are yet to innovate. Your comments

TB was largely considered a public sector domain with strained resources even to provide treatment, leave alone diagnostics. While a number of companies were involved in the manufacture of serological tests and microscopic reagents, it was long felt that molecular tests would not be able to compete with the former owing to high price points. Hence companies generally did not see a market for innovative products in this segment. Lack of a unified algorithm for diagnosis and treatment, an evolving regulatory environment and constraints in support for research and innovation in the private sector have also been responsible, although things are changing in the recent times. There needs to be an ecosystem for technology innovation. That said, with the realisation of the inadequacy of smear microscopy and the ban on serological tests, the market is now open for adopting newer technologies.

Is funding hard to come by for companies focusing on TB diagnostics?

Yes and no. The Indian Government is very supportive of industry through schemes like New Millennium Indian Technology Leadership Initiative (NMITLI), Biotech Industry Partnership Programme (BIPP), Small Business Innovation Research Initiative (SBIRI) and Technology Development and Demonstration Programme (TDDP). However, the government needs to be more involved in ensuring that products developed successfully by Indian companies are available to the Indian population. India has a poor manufacturing set-up for cutting-edge diagnostics, which could benefit tremendously by infrastructure development support by the government. Else, we are forced to rely on developed countries, which in turn, drives up costs. While BIPP helped us validate the tests, the NMITLI took a leap of faith in us and provided us with a soft loan that helped us invest in cutting edge technology and develop the platform.

What was the driving force behind the Truelab test? How did you arrive at such a solution?

Uncertainty in the causative agent leads to misuse of anti-microbials and consequently a build-up of drug resistance. Faster and better diagnosis leads to automatic reduction in patient suffering and the spread of infectious diseases. It has been felt that molecular diagnostic technology could close all these gaps; however, high cost and paucity of trained technicians and labs has been a constraint.

Our attempt was to make a product that brings TB diagnosis to the patient such that it could be used by low level technicians as well. We also realised that any business model for TB can be successful only if it can be deployed till the very bottom of the health care chain. Years of assembling multi-disciplinary teams of engineers, chemists and biologists while building sustained partnerships with prestigious institutions like AIIMS, CMC, IISc, IIT, NIMHANS, NIMR, NIV, SJRI etc have helped us realise our vision.

How huge is the market for TB diagnostics in India? What is the marketing strategy going to be like?

Estimate for market size have varied from 20 million tests per year to over 40 million tests per year. However, considering the reported number of TB suspect patients presenting to RNTCP, one can say that approximately at least 25 million tests are done per year on suspected TB patients in India.

The marketing strategy is to promote our technology to even the smallest of labs and Primary Health Centres (PHCs) all over the country who could otherwise not even dream of doing a PCR test. We will highlight the ‘Any Time, Any Where PCR’ capability to motivate even field level testing. At the same time, we shall be engaging the RNTCP for their adoption of our system in the programme. We plan to take the platform to our 70 plus distributors worldwide for deployment in their countries.

What is the procedure to be followed before such a test comes to the market?

Once the test is ready, we conduct internal validation at our company followed by an external validation that is totally independent and is conducted by hospitals and labs, for instance the study conducted at Hinduja hospitals. The test now needs a drug-manufacturing license issued by the state drugs controller. If imported, an import license from the DCG(I) is necessary. Tests like HBV, HCV and HIV (categorised as critical) need further evaluation by the central laboratory (NIB). WHO does not have a pre-qualification for TB, however, they do endorse tests based on peer review of reported performance. We are working on evaluations by national TB labs towards engaging RNTCP for further adoption.

Tell us something about the validation studies of chips for malaria, dengue, chikungunya, H1N1, typhoid and Hepatitis B.

We have performed extensive in-house studies on the precision, reproducibility and other analytical parameters. While some of the tests have already been thoroughly validated, multi-centre studies evaluating the performance of Molbio’s newer tests on the Truelab platform are underway. The performance compares well in terms of turn-around time, sensitivity, specificity and ease of use with existing tests in the market.

While a point of care test is much called for, regulatory policy goes a long way and integrating such tests in the diagnostic algorithm. Your comments.

India needs to first have a national policy for TB that would also cover the private sector with clear algorithms. The regulatory system must be beefed up to ensure implementation of the policy. There should also be a clear and transparent mechanism for monitoring the quality of diagnostic tests prior to introduction and also post market.

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