Genetic testing can help in choosing the right drug and the right dose for a patient

Dr Vijay Chandru, Chairman and CEO, Strand Life Sciences, gives a rundown on the genetic diagnostics market in India, its future prospects, his company’s share in this fledgling market and how genetic diagnostics would impact healthcare in the coming years, in an interaction with Lakshmipriya Nair

How big is the market for genetics diagnostics in India? What is your share in it?

The overall molecular diagnostics market is perhaps at about three to four thousand crores. In genome sequencing based diagnostics, Strand has perhaps a 30 per cent market share today in India. We work with about 100 hospitals and clinics in the country and over 200 physicians use our tests for their patients on a regular basis.

How far can the information received through genetic testing be reliably used as the basis for healthcare decisions?

There are two types of genetic signatures that are useful for healthcare decisions. Mendelian variants in specific genes are the source of risk of various inherited disorders and these genetic tests can confirm a diagnosis and trigger preventive measures. As an example, Angelina Jolie has now created a great awareness about the risks associated with genetic markers for breast and ovarian cancer.

There are also pharmaco-genomic variants that can be indicative of how effective or adverse a specific therapy (drug) can be in treating the patient. Selection of specific chemotherapies, targeted therapies and the dosing for cancer treatment based on genetic variants is now considered as an emerging new guideline for standard of care.

What are the opportunities and challenges associated with this sphere?

In personalised and precision medicine, genetic testing can help with choosing the right drug and the right dose for the individual patient. This has been effectively demonstrated in the care of many cancer patients. There are also great opportunities in preventive care of people whose risks for diseases can be estimated from genetic dispositions and appropriate preventive measures including many lifestyle changes can be effectively brought to bear. Cardiac disease, neuro-degenerative and cardio-vascular disease are particularly significant in adults and seniors.

The challenge is that we have only learnt to interpret about 20 per cent of the genes in human DNA. So there is a lot of signal from genetic testing that we simply do not know how to interpret. Knowledge is expanding rapidly and highly trained and large scale knowledge curation is required to address this challenge.  Strand has a very special approach to this which has made us a global leader in interpretation.

Tell us about your offerings in this arena? How do they help in effective healthcare delivery? How have they been received?

We have the market lead in the following areas

• Multi-genic NGS panel for solid tumour profiling
• Multi-cancer familial risk panel
• Clinical exome panel for rare disease diagnosis
• Specialised panels for cardio and eye related inherited disease

Strand Centers for Genomics and Personalized Medicine provide exceptional genetic counselling both at a pre-test and post-test stage. We have counsellors spread across the nation and we strongly believe that genetic testing should be inter-mediated by medical professionals. Genetic testing done ‘direct to consumers’ and overt advertising to consumers is fraught with ethical problems since these are highly technical and yet life changing diagnosis, and there are possibilities of misunderstanding by patients and their families. Our quality of tests and particularly our interpretations are deeply appreciated by physicians who can use them as decision aids in selecting treatment options.

What’s your way forward in this area? Any significant tie-ups with other players which would help you gain a firmer foothold into this market?

In India we already have corporate relationships with hospital networks like Max, Narayana Health, HCG, Apollo, and also a number of smaller specialist groups. We work with many of the key opinion leaders in the medical specialities that we serve.

In the US, our CLIA lab at Aurora, Colorado is up and running and we are in the market with direct to physician sales. We have an exceptional scientific advisory board with leading oncologists and clinical biologists from Dana Farber, National Jewish, LV Prasad Eye Institute, Duke University, Boston University, etc.

We believe that we will continue to be the market leader in the space of complex multigenic testing in India and will grow the market for the whole field. This is an emerging area of personalised and precision medicine which is happening now in India just as it unfolds in the West as well.

How affordable are these tests for the Indian market?

We have taken affordability as a key driver of innovation in order to address the Indian market but more importantly to take on the global market with the advantages of a lower cost base. Even in the West and in health systems like the US there is tremendous downward pressure on reimbursements for molecular diagnostics and Strand will be better prepared than its competitors to deal with this pressure because it is ‘Made in India’.  As our board member, Ravi Venkatesan (former Chairman of Microsoft India) has written ‘Win in India, Win Everywhere’.

In India, we are driving towards pricing that is on the same order of magnitude as a PET scan which is perhaps one of the most expensive diagnostic tests that has become a standard of care. So these tests are not cheap but they are affordable. We believe that the value provided to patients by enabling physicians make better decision based on deeper insights justifies the price. But the market will speak.

What is the scope for personalised medicine in India?  What role does Strand Life Sciences envisage for itself in this sphere?

Strand is participating in bringing personalied and precision medicine to the Indian healthcare establishment in a responsible, ethical and scientifically validated manner. We are working with the medical establishment to define new guidelines of bringing this practice into the mainstream of medical practice, and are carrying out exceptional translational research with our partners in Mazumdar-Shaw Medical Center at Narayana Health which will put personalised and precision medicine in India on the global map. India has been a global leader in affordable medicines, affordable surgeries and affordable hospital care. There is no reason why we cannot be a global leader in affordable personalised and precision medicine.

What aboutsecurity of the information you provide? How do ensure that it does not get misused?

Our technology platforms follow the best practices and are certified to be HIPAA compliant. If labs and diagnostic companies follow the regulatory regimes of NABL, CAP and ISO in a genuine way, these will automatically ensure security and ethical use of data. At Strand we have an internal Institutional Ethics Review Board that oversees and clears all our processes as well as the specific tests that we launch.

It is time for a national legislation along the lines of a ‘genomic information non-discrimination act’ (GINA was passed in the US in 2009) that would protect citizens from misuse of their genetic data.

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