‘We are aggressively pursuing research in the field of molecular pathology and genetic analysis’

Rajan Datar, Founder, Datar Genetics explains to Raelene Kambli, on the opportunities  and challenges in genetics for India and also talks about Datar Diagnostics’s  partnership with Apollo Hospitals Educational and Research Foundation (AHERF)

What is the scope for genetic diagnostics in India? Which areas of genetic testing has prospered in India so far?

Molecular genetic diagnostics is still in its infancy in India. It may take another three to five years before this speciality matures.

If you compare with the West or Far East, India is lagging behind when it comes to imbibing molecular genetics in clinical practice. Cytogenetics so far is still considered the bench mark. The reason being limited laboratories with availability of sequencing platforms and lack of exposure to clinicians regarding molecular diagnostics. The same can be inferred by comparing Indian cancer patient survival data with that of the West.

There is tremendous potential in the molecular diagnostic market in India, particularly in oncology. However still a lot of awareness and education is needed. Cytogenetic methods like Fluorescence in-situ Hybridization (FISH) and Immunohistochemistry (IHC) have a limitation of sensitivity and specificity, almost 20 per cent grey zone exists and if you were to decide your chemotherapy based on such tests for patients with breast cancer, colorectal cancer, then definitely we need to relook into the evidence. Even American Society of clinical Oncology (ASCO) acknowledges this fact.

In India, genetics invariably limits itself only to the reproductive medicine part. Fields like pharmacogenetics, oncogenetics are yet unheard of. There are not many specialised clinicians in this field. Newly introduced liquid biopsy tests like CTC and ctDNA need to be familiarised and utilised appropriately. These are novel tests, the platform for which has been developed by DGL. The oncology practice will definitely benefit from such novel tests.

It’s time we move on from cyto to molecular genetics.

What are the opportunities and challenges associated with this field in India?

Medical genetics is a neglected field in medical sciences. Today, we have several scientists working on genetics but the major hindrance is their lack of clinical knowledge, as the majority come from life sciences background. Very few medical universities are imparting medical genetics knowledge to medical graduates and post graduates, though this scenario has begun to change.

Hence in this field it’s a dual task, to educate the clinicians and create opportunities by inculcating and imbibing molecular genetic tests in practice. For instance, almost every physician treats heart patients. Anti-coagulants and anti-platelets are some of the most commonly prescribed drugs. Yet over informal interactions with numerous physicians, we found that almost 80-90 per cent were unaware of pharmacogenetic tests for such drugs, forget about prescribing these tests.

We need to look at the current guidelines and evidence. Definitely there’s an argument that there is no Indian data, isn’t it? We need to emphasise on whatever evidence we have as of now and develop where there is meagre. But that ain’t no excuse we need to start somewhere. We need to exploit the newly available testing platform for the best.

Cost is another factor for such tests. But one fact needs to be highlighted, some laboratories are doing FISH and IHC based tests for Rs 12,000 to 18,000/- , DGL is providing pharmacogenetic testing for Oncology drugs for Rs 8,500/-, similarly other pricing are also reasonable. Yet we should acknowledge that technology comes with a cost.

What are the trends in this field? What kind of research is underway in this field?

The field of molecular genetics is very promising, a lot of research is going on at the international level. What is striking is that India contributes to less than five per cent of such research, a lot of data comes from west and Far East. China has made tremendous progress in this aspect. The current need is however to focus more on the translational part of research. If any amount of evidence is to remain in the lab then it’s pointless. As much we adapt in clinical practice, there is bound to be new learning.

In India, lot many public sector and private sector enterprises are conducting research in this field. It’s time we have conclaves and interactions amongst these research scientists and clinicians across various specialties for the better. The question of Indian data will broadly be addressed in such a way.

Which areas of genetic testing do you cater to?

DGL desires to be the pioneer institute when it comes to Molecular Genetics. Presently DGL offers genetic tests in the following specialities

• Oncology: Tumour genome sequencing, tumour exome sequencing, tumour and paired transcriptome sequencing, tumour tissue molecular characterisation, liquid biopsy – circulating tumour DNA, circulating tumour cells, pharmacogenetics for chemotherapy drugs, hereditary cancer testing.
• Cardiology: Pharmacogenetics for cardiology drugs, hereditary cardiac conditions testing
• Diabetes: Pharmacogenetics for diabetes drugs, genetic test for neonatal diabetes and maturity onset diabetes of the young
• Neuro-psychiatry: Pharmacogenetics for neuro-psychiatry drugs
• Reproductive medicine: Non-invasive pre-natal testing, pre-gestational diagnostic testing, pre- conception/ marital genetic screening, neonatal and new born genetic screening
• Geriatric: Pharmacogenetics for osteoporosis and nutrigenomics testing

Are there any ethical issues that plague the genetic diagnostic sector in India?

Ethical issues are indeed there. But what’s more important are the legal issues. With such a hue and cry regarding PCPNDT going on, it’s time we make known that molecular genetic tests are larger than just reproductive genetics. If you leave apart NIPS and PGD, still there are pharmacogenetics for various specialities, oncogenetics etc. much beyond the purview of PCPNDT.

There are different takes on incipient findings of the genetic tests, also patient privacy and confidentiality. Here decisions need to be taken on case to case basis, also medical ethics need to be remoulded into medical genetic ethics. A lot of literature evidence and legalities are being developed, we need to promptly update ourselves.
Right from patient consent to test, to confidentiality while sample processing, analysis and reporting, issues need to be addressed at every level. Again genetic counselling is a very important issue which needs to be addressed.

What is the business approach adopted by you to reach out to the masses? How have you benefitted by this approach?

I wouldn’t really say that we have a business approach to this. Doctors have been very appreciative of this technology- as it enables them to treat their patients better.

What are your plans for Datar Diagnostics in the coming months?

We are aggressively pursuing research in the field of molecular pathology and genetic analysis to offer wholesome service from pre-disposition assessment to post-diagnosis management and recurrence monitoring. Our area of focus is cancer, reproductive genetics, cardiovascular disease and transplant genetics.

You have also tied-up with Apollo Hospitals, can you throw some light on this partnership?

Datar Genetics’ strategic collaboration with Apollo Hospitals Educational and Research Foundation (AHERF) will help us establish a liquid biopsy platform for detecting Glioblastomas (GBM), one of the most aggressive malignant brain tumours in humans.

Management of GBMs remain challenging as there are no current curative treatments and therefore, mortality rates continue to stagnate at high levels. This research is critical, from the point of view of effective treatment as well as pharmacogenetics.

The global market size for diagnosis of brain tumour is about Rs 500 crores. The Indian market is estimated to be roughly eight per cent of this. The real cost, however lies in the amounts spent post mis-diagnosis. A trial and error based approach can lead to much heartburn and high costs. Only 15 per cent of the existing incidences worldwide are diagnosed correctly at present.

Datar Genetics, by virtue of a state-of-the-art facility at Nashik and a specialised team of scientists, has undertaken the challenge to translate this liquid biopsy technology into a clinically applicable diagnostic platform which will immensely help the neuro-oncologists to stratify tumour patients in real time for disease progression and therapy response.

AHERF will provide Datar Genetics the necessary technical and clinical support for co-validation of the assay. For the same, AHERF has assembled a consortium of Apollo Hospital’s neuro-oncologists to conduct collaborative research to understand brain tumours.

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