More than three decade old molecular biology company XCyton Diagnostics has already carved its presence in the Indian market and are offering solutions at a competitive range. Dr BV Ravikumar, Founder and Managing Director, XCyton Diagnostics shares the company’s plans with Usha Sharma
Since the 90’s you have been in the molecular diagnostic business and have seen the different diameters of it, tell us about key findings/learnings?
In the last three decades there has been a significant shift in the molecular diagnostic business. Molecular biological methods for the detection and characterisation of microorganisms have revolutionised diagnostic microbiology and are now part of routine specimen processing. One of the foremost development was the commoditisation of ELISA kits for various infections. Because of this a strategic major decision was taken to address unmet diagnostic need of life-threatening infections. We had foreseen in 2004 that Anti-Microbial-Resistance and complex syndromic infections would be the future of diagnostics. Sadly, we are proven right.
Give us a brief understanding of the company’s ongoing activities and how are you scaling up your research capabilities?
Strategic discovery and development are directed towards design of diagnostics for maximised clinical relevance. We already have proprietary signatures for 69 pathogens and in coming 12 months we will add 18 more pathogens to our list.
How big is the molecular diagnostic market in India and what percentage is it growing annually?
The market potential as calculated by computing all the diseases that necessarily require molecular diagnostics for preventing mortality and morbidity is $1 billion which is a Rs 7000 crore market in India.
The company was involved in manufacturing immuno-diagnostic kits for the detection of infections, tell us more about it.
We had only one product in the immuno-diagnostic category named ELISA. We have stopped it from 2011.
Why did you stop manufacturing immuno-diagnostic kits?
Our kits were marketed by Qualigens (Subsidiary of GSK) which was later acquired by Thermo-Fisher. Due to commoditisation of ELISA kits and the resultant price wars they were not interested in blood banking and other urology market in India. Due to the drug licensing policy, we were classified as a pharmaceutical company and in order to get some investments from international funds we gave up the licenses.
Though the infectious disease diagnostics market is growing significantly globally, there is an absence of compiled regulatory guidelines and lack of centralised laboratory facilities, how do you address this issue?
Many countries have clear cut guidelines. Yes, India is modifying and amending the IVD (in-vitro diagnostics) guidelines. Central labs are mainly responsible for diagnostic delivery in all countries – advanced or developing. Even very small countries have central labs but no access to point-of-care diagnostics. Developing nations have vast regions of country with poor connectivity to avail central lab tests. Our plans are to make Syndrome Evaluation System (SES) a POC device. We are in process of raising necessary resources.
Tell us more about XCyton’s Syndrome Evaluation System (SES) and how it is different from other available products in the market?
When a doctor sees a patient with a life-threatening infection, SES tells them the exact pathogen and whether it is resistant (a superbug) in a few hours. Everyone else takes a few days. Plus, we can do things others cannot:
1. Doctors already use our SES to stop unnecessary antibiotics or change therapy to the right one.
2. If we report zero infection doctors look for non-infectious causes for the disease.
What solutions do you offer for critical care management and how it helps physicians to assess, diagnose for treatment?
We offer our solutions to critical care doctors, a single-test diagnostic for about 20 types of complex clinical conditions, that they see regularly such as sepsis, meningitis, pneumonia, encephalitis etc. In each test, we look comprehensively for all pathogens which cause 95 per cent of each illness in India. Others look for far less number of pathogens. We diagnose more pathogens important to India and worldwide, not just those in North America or Europe. From one test, we can find more resistant superbugs than all our competitors.
Tell us about your business strategies and how are you expanding your presence globally?
We have tied up with MedGenome Labs in the domestic market for infectious disease genetic test to leverage their strong presence even in tier 2- tier 3 cities. We are moving to expand our lab services internationally with ongoing studies in Singapore and soon to start in the US and EU. Later, we plan to develop a point-of-care devices to be used, at the ICU patient’s bedside.