‘When regulation becomes ill-defined and ambiguous, all industry players suffer’

Recently, Strand Life Sciences has signed an MoU with El Camino Hospital. Tell us more about the agreement?

Dr Vijay Chandru

Strand is well known in the genomics community for building the “gold standard” informatics tools for secondary and tertiary analysis of molecular data. We serve well over 2000 labs worldwide which amounts to about 30 per cent global market share. The El Camino Hospital is both a community hospital and a research savvy hospital. Being located in the technology hub of Silicon Valley in Mountain View also means that the community is very open to new breakthrough technologies like genomics. This made El Camino Hospital an ideal partner for Strand’s entry into the US healthcare establishment.

When we entered the emerging domain of “clinical genomics” or the use of genomics for personalisation of medical treatment of patients, we were soon seen to be a front runner because of the history of being a strong informatics player for over a decade. We have rapidly established a clinical genomics practice in India with over 20 hospitals around the country. This includes next generation sequencing of DNA samples from patients at these hospitals, analysis of the data and clinical interpretation of the patterns found and related clinical advice to the attending physicians. We only work with physicians and not directly with patients because of the sensitivity of the medical advice. We also provide genetic counselling appropriate to the tests and follow closely the best practices and guidelines of the American College of Medical Genetics in our reporting.

The leadership of El Camino Hospital had been evaluating several candidate partners for providing clinical genomics services to their community through their centre for medical genomics. Over the last six months of interaction with Strand, they were convinced of the quality of our services and have entered into an understanding with Strand to establish a Strand Centre for Genomics and Personalised medicine at their hospital.

How much would you like to invest in setting up a new lab at El Camino Hospital and how do you plan to raise the fund?

Strand has raised a series B round of $10 million in February 2013 from Biomark Capital Partners of San Francisco. We are adequately funded to implement this project.

What research work have you planned through this partnership and how it will be beneficial to the Indian patients?

El Camino Hospital runs a famous programme known as the “The South Asian Heart Study” which currently has around 4,500 volunteers from South Asia who are residents of Silicon Valley. We plan to extend the heart study by also testing a large fraction of the volunteers for their genomic profiles that may indicate predispositions to certain types of cardiac ailments. A large fraction of the study subjects have consented to such profiling and their DNA samples have been collected. The learning from such an exercise would be enormous for South Asians everywhere including India of course. The pharmacogenomics research programme would also eventually benefit patients in India.

As per the agreement, research will be carried out in areas of advanced genomic tests in cardiology, oncology, pharmaco-genomics and personalised medicine to the community served by the El Camino Hospital. By when will the tests be launched in the market?

The initial focus of the services would be in profiling of genomic risk for cardiac diseases, diagnostic tests in oncology for both somatic profiling of tumour DNA and for germline cancer risk, whole exome personal genome profiling of community members and a novel pharmacogenomic test. The first three tests are already on offer to Strand customers in India while the fourth (pharmacogenomics) is being developed with researchers at El Camino Hospital as a collaborative project.

What are the other focus areas identified under the partnership?

Other areas would evolve and are under discussion. We have talked about running an annual clinical genomics conference along with El Camino Hospital to bring about awareness of these tests to the community.

Biotechnology regulations in India are still at a nascent stage. Do you think it will affect the industry in the long run?

Yes of course! Regulation affects industry but at the same time it is necessary both ensuring quality and ethical standards are maintained. Responsible industry usually would like some regulation to ensure that the market does not get spoiled by unethical players. It is when regulation becomes ill-defined and ambiguous that sometimes all industry players suffer because of the arbitrariness.

Are there any regulatory guidelines concerning genomic testing for clinical and medical applications?

I personally, and Strand as a company, have taken the position that in genomic testing for clinical and medical applications, industry should not be allowed to directly solicit consumers (patients) and directly report to consumers without a physician intermediary. This dangerous practice has been shut down in the US by the FDA in recent times but continues to thrive in India. I would like to see ICMR take a position on this and have made it known to the concerned officials in the Ministry of Health and Family Welfare.

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