‘’HPV screening market seems to be growing in excess of 20 per cent annually’’

How do you look at the Indian diagnostics market? What are the opportunities and challenges?

Lowell Gruman (LG): Diagnostic screening is beginning to gain importance in India as more and more people are becoming aware that early treatment is often a good indicator of successful treatment. For example, highly specific screening assays, such as HPV OncoTect, identify actual disease rather than the risk of or predisposition to disease. However, the market for such assays in India is, for all intents and purposes, in its infancy. While India’s medical training infrastructure continues to add increasing numbers of highly-qualified professionals to its healthcare delivery programme, there are large segments of the population that remain underserved. For companies like ours, with novel, high-performance technology, India represents an opportunity to reach into and beyond the current footprint of standard healthcare delivery at a fraction of the cost associated with early stage cancer detection. We are mindful that we are not alone in seeing India as an attractive growth opportunity.

Dinesh Gupta (DG): The Indian diagnostics market is largely skewed and unorganised. There are only a few large players with extensive networking of collection centres, engaged with run-of-the-mill services. Technical promotion is weak. Gullible patients undergo lab tests at a rapid frequency and repeat testing requests. While the routine clinical market is growing at a CAGR of 9 to 10 per cent, molecular testing market is at above 25 per cent. There are immense opportunities to promote molecular point-of-care procedures. The biggest challenge is to enhance awareness among common people, including that of cancer prevention procedures.

How does IncellDx distinguish itself from its competitors?

LG: IncellDx is at the cutting edge of new developments in molecular diagnostics, as our technology quantifies intracellular target biomarker activity while retaining the morphology of each cell, allowing critical cell-cycle analysis and determination of the nuclear cytoplasmic ratio. Competitively, companies must push the performance boundaries that currently exist: introducing an assay that produces the same result as the next test in a different manner is no longer good enough.

DG: Market is evolving to a large extent by introducing the newer generation of tests in cancer and sexually transmittable diseases. There are not many competitors in this area, technology development companies like IncellDx are working around developing multi-parameter single test services that potentially could detect more than one STD in a single assay.

What is India’s cervical cancer burden? By how much is HPV screening market growing?

LG: The politics of the disease will generally drive a different answer to your question in every country, and each healthcare system should determine the priorities within the scope of its own resources. That being said, early stage cancer detection is on everyone’s list of priorities. And because technological step-changes tend to grow the current market, year-on-year the growth metrics don’t carry much meaning unless seen in the broadest of senses. That being said, HPV screening market in all its forms seems to be growing in excess of 20 per cent annually.

DG: Out of 100 women globally acquring new infection, 33 are from India and half of them die due to lack of treatment. Every third woman newly diagnosed with cervical cancer is Indian. Lack of awareness on cervical cancer prevention, no insurance reimbursement cover for preventive diagnostics and a lack of clear understanding/consensus among policy makers for cancer detection programmes are a few challenges. Few state governments have already introduced universal screening for cervical and breast cancers, a PPP in this area will be rolled out soon.

What is the market size for HPV screening? What are the drawbacks of current HPV tests and what advantages does the new test offer? Is it designed to function in low resource settings?

DG: Nearly 10 million women out of 150 million in the age group of 25 to 59 could best benefit from screening at least once in three to five years. The current HPV test only detects presence of HPV infection while missing on harmful HPV infection that can potentially lead to cancer development. With HPV infection so common among sexually active women, identifying any HPV infection is clinically no good. From a doctor’s point of view, despite being a sophisticated molecular test, it helps handle biological specimen without having to isolate or purify viral DNA while identifying the correct location of HPV infection in women’s genitalia. Yes, it is designated for better use in the low resource setting too, provided one bears in the mind that disease treatment costs many thousands of bucks with poor survival rate too, and that you do not need to repeat the test at a rapid frequency. The test also has a negative prediction over several years, so one saves money on needless procedures like repeated pap tests, colposcopies, biopsies and so forth. The incremental costs for disease prevention are far lesser than disease treatment.

What should be the parameters of a good HPV test?

LG:The performance of any assay should ultimately be determined by its clinical usefulness. The best assays are both highly sensitive and highly specific, and are able to inform the clinician with a strong argument for either treating or not treating a patient.

DG: A good HPV test should have

• high sensitivity >96 per cent (disease pick up rate- very high)
• high specificity >90 per cent (pick up women with no disease as normal)
• high correlation with clinical identification of pre-cancer disease
• high reproducibility (positive as positive on repeat testing)
• affordable cost as a screening test
• results easy to interprete

How big is the molecular oncology testing market in India?

DG: Of the nearly $ 650 million Indian diagnostic market, molecular oncology contributes to nearly seven per cent. This is a market in transition in India. We have just begun to accept liquid cytology or VIA/VILI as potential screening tools. Our government recognises the importance of CA, CX screening; in a way that few states in India have already begun rolling out programmes in the public domain. Since the incidence of both CA, CX as well as BRCA is highest in our population, we estimate over a million tests market for any screening procedures. However, the current BRCA screening tests are insufficient, lack sensitivity. Most diseases are detected in advanced stages where treatment failure is high and consequent deaths are imminent. We wish to change this scenario.

Companion diagnostics are the cornerstone of personalised medicine. Does Incell have any tests along these lines or plans to introduce such tests?

LG: IncellDx technology is ideally suited for use in companion diagnostics for pharma therapies, particularly newly-developed therapies that must hurdle increasingly higher performance metrics to achieve regulatory approval. We are working on several projects at the moment with strategic pharma partners and will be announcing these later this year. A non-invasive, early stage breast cancer screening assay is under development at the moment. Once the assay has been fully confirmed and validated we would not hesitate to make it available to hospitals and reference laboratories in India.

shalini.g@expressindia.com