Technology

Diagnostics Special

The diagnostics segment in India, considered a part of the services segment of the biotechnology industry, is already at forefront of the silent revolution in healthcare delivery models. We see companies setting up chains of diagnostics laboratories, some of them reaching out to the rural hinterland of the country. Within these laboratories and in hospitals across the country, we have a relatively new set of diagnostic tools, which work at the molecular level, to 'see' into our genes and predict possibility of disease and once diagnosed, another set of tests to help doctors customise treatment depending on disease load.
In our first Diagnostics Special, we profile two companies, who probably typify hundreds of Indian diagnostics-based entities at various stages of the business development cycle. While Yashraj Biotechnology came up with an innovative project to purify proteins, the antigens in such kits, from human biomedical waste, Acton Biotech's diagnostics tests help a doctor measure disease load in cancer patients and thus decide treatment regimen. Sachin Jagdale analyses the growth paths of these two companies.

A company with a difference

Yashraj Biotechnology is one of those companies that have achieved significant respect in the immuno-diagnostics market within a short span of time.

Yashraj Biotechnology Limited (YBL) is today a strongly positioned name in the field of biotechnology. Since its inception in 1999 YBL has come a long way, based on the philosophy that the power of biotech should be used for the well being of society. This humanitarian approach has indeed made YBL a company with difference.

The vision of the company is to bring benefits of molecular diagnostics to the frontlines of healthcare in India, and make diagnostics affordable and easily available to the common man. Molecular diagnostics is a discipline that captures genomic and proteomic approaches to assess an individual's risk for contracting a disease or diseases much before the onset of symptoms. In fact, this timely recognition of the importance of molecular diagnostics for health benefits is one of the founding principles of YBL.

Expanding on the company's vision, Dr Chander Puri, Chief Executive Officer,YBL says, "A significant number of patients from remote and rural areas of our country do not seek treatment and succumb to disease before a diagnosis is made. Such premature deaths can probably be avoided by providing better healthcare facilities including affordable and easily accessible diagnostic facilities." As ship with sails is directionless without an experienced crew, it goes without saying that the able and visionary leadership of Puri, and his scientific advisory board, is one of the crucial factors that have made YBL grow and flourish. Puri himself has many feathers in his cap. A PhD from All India Institute of Medical Sciences (AIIMS), New Delhi he did his postdoctoral training at Karolinska Hospital, Stockholm, and Washington University School of Medicine, St Louis, USA. He also worked for a brief spell in the Department of Reproductive Health and Research, World Health Organization (WHO), Geneva. Dr Puri served as the Director of National Institute for Research in Reproductive Health until 2007. He has published over 100 articles in journals of national and international repute.

Puri's strong backup of well experienced directors includes Paresh Bhanushali,director, YBL, Research and Development, and Production who has a masters degree in biotechnology from Indian Institute of Technology (IIT). Bharat Dagha directs marketing and business development as a founder director with over 30 years in banking, finance, forex, sales and administration. Independent directors like Dr Pankaj Shah and Pisupati Subrahmanyam have already proved their credentials. Shah is a practicing pathologist with over 20 years of experience while Subrahmanyam is a retired IAS officer who has served as Chief Secretary to the Government of Maharashtra.

Giving details of their product basket, Puri informs, "The focus of research, development and production at YBL is in the area of infectious diseases to develop combo-tests, and molecular oncology tests. In addition, molecular biology tools for inherited disorders, cardiovascular disorders and acute respiratory disorders will also be developed. Keeping this in view, YBL jointly with the Department of Biotechnology (DBT), Government of India had recently organised a workshop to develop a road map for developing molecular diagnostics through industry-academia partnerships".
Most imported kits for immuno-diagnostics are expensive and YBL is putting in lots of effort to make immuno-diagnostics available at more affordable costs. The company has an innovative project to purify proteins, which serve as antigens in such kits, from human biomedical waste. This endeavor of YBL would not only help reduce cost of diagnostics but also serve as a 'cash from trash' environment friendly way to dispose off infectious biomedical waste.

YBL seems to be a leading choice for worldwide diagnostic and biotechnology companies for native antigenic proteins having consistent quality and quantity and also for customised formulations of native antigens in accordance with their intended use. Contract manufacturing of desired antigens, either through joint R&D ventures or exclusive technology transfers for buy back is yet another area where YBL is in demand.

Any company in the market gets identified with the quality of its products and when it follows all national and international norms, its reliability strengthens further. YBL is proving to be one of these trustworthy and reliable biotech companies. Puri provides details about various certifications that YBL has received. He says, "At YBL the native antigen facility is ISO 9001:2000 certified; the cell culture facility is as per European Medicines Agency (EMEA) and US Food and Drug Administration (FDA) guidelines; the quality control facility is as per US FDA requirements and is ISO 9001:2000 certified; and has US FDA grade infectious disease testing facilities. The company's R&D and product development programmes are approved by the Department of Science and Industrial Research (DSIR), Ministry of Science and Technology, Government of India."

Yashraj has developed self sufficient facilities like cell culture facility, quality control, R&D development and experimental animal house. YBL is coming up with new facility, measuring about 150000 sq feet, available for development of manufacturing plants.

The company's current product list includes C-reactive protein, hepatitis B surface antigen both Ay and Ad subtypes, breast cancer marker (CA 15-3), gastrointestinal cancer antigen (CA 19-9), ovarian cancer antigen (CA 125), gastric cancer antigen (CA 72-4), carcino-embryonic antigen, alpha-feto protein, beta-2 microglobulin, prostate specific antigen, myeloperoxidase etc.

Puri reveals that the company is soon to take a significant step by venturing into a public private partnership (PPP) in the development of diagnostics based on immunological principles, DNA detection system, and instrumentation, which can be marketed in India. YBL has proved its mettle thus far, it remains to be seen wether it can stand the test of time and global as well as domestic competition.

sachin.jagdale@expressindia.com

A 'gene'ous at work

Pune based Acton Biotech claims to be the only laboratory offering genetic analysis to check drug suitability.

In most cases, medicine heals but it sometimes harms as well. This state of uncertainty has remained a core concern of the medical fraternity for a long time. In the same vein, side effects may outweigh benefits. However, what if the entire treatment itself goes wrong? This could happen when doctors do not know the suitability of a particular drug to a particular patient and the patient continues with his prescribed medication. In diseases like cancer where a patient is heavily bombarded with chemotherapy, irrespective of his ability to adapt to or response to this highly toxic method of treatment, it may take away his life long before the cancer does.

In response to this need, the diagnostic fraternity has developed tests which are able to map how different patients (differing genetic composition) respond to the same drug. Pune based Acton Biotech has set up India's first and only laboratory dedicated to offering these tests. These tests are called pharmacogenomic tests as they are based on pharmacogenomics, the study of how genetic differences affect drug response in populations. Currently, Acton offers tests to identify patients who are at great risk of developing severe toxicity from commonly used cancer drugs, 6 Mercaptopurine and 5 Fluorouracil.

Sandeep Saxena, a founder and CEO of Acton, is a graduate in life sciences. He first heard about the powerful concept of pharmacogenomics way back in 1994 when he was at Mumbai's Tata Institute of Fundamental Research (TIFR), gaining hands--on research experience in genetic techniques from Professor B J Rao. His curiosity and belief in the potential of pharmacogenomics led to the formation of Acton.

There was a well planned scientific study behind the inception of Acton. Reliving those days, Saxena says, "We invested close to three months on writing the business plan. We did a lot of literature study, industry study, financial projections and marketing plan. Then we sent the plan to around 30 experts in the industry and asked them to critique the plan. We took all the criticism and tried to get answers. This document was ready in February 2006. We have not modified the plan and are following it till date. The same document will be followed for the next five years." He adds, "I was really very lucky in latching on to this idea. The idea was so powerful that every time I was stuck in a problem, there was someone to bail me out. I got a great set of employees, great set of investors, great set of mentors, good suppliers, and last but not the least, a great set of customers who kept demanding (more) tests from me."

Currently cancer is the main focus area of Acton. The value proposition of cancer tests at Acton is also very interesting. Cancer drugs are expensive,have a narrow therapeutic window and all patients are different. Selecting a set of drugs is a big challenge for a medical oncologist. Consider the numbers: On an average cancer therapy costs Rs 50,000. If a patient suffers from severe side effects and requires strong antibiotics, a stay in the Intensive Care Unit (ICU) and other supportive care, this could add another Rs. 50,000 to the outlay. But all this can be avoided by a simple test which costs Rs 3000.

Though the sufferings of cancer patients are more severe than other diseases, these patients also deserve equal attention. India is often dubbed the diabetes capital of the world. Diseases like asthma and arthritis are also on the rise. So how long will it be before we see tests for these diseases as well? Saxena opines, "For other diseases, side effects are not so severe and cost of drugs is not that high. The entire industry has to take efforts and invest in research to bring the cost down. That's when we will be able to target other complicated diseases like TB, AIDS, asthma, diabetes, central nervous system disorders and cardiovascular disorders. We will get into these diseases after one year."

The response to this novel way of deciding treatment has indeed started changing the way doctors prescribe medicines. In fact, this is what doctors were looking for. The customer base of Acton has expanded so fast that now they have repeat customers. Acton's own lab was set up in Mumbai’s KEM Hospital and was fully functional in March 2007. "Right now we are getting around 100 samples per month. We have a target of reaching 1000 samples per month by this year end and a revenue target of Rs 1 crore," says Saxena.

As patients are at the core of this exercise, they should be made aware of what they are going through. Not all the patients are literate to understand the concept of pharmacogenomics. However, Saxena makes this complex term simpler by telling patient that "cause is in our genes and we can study their genes and avoid side effects." Patients are educated without using any technical terms. But to the surprise of Acton, patients are now searching the internet and come up with scientific questions.

Though riding high on the wave of success, Acton is not in a rush to set up another laboratory. One reason is the lack of experienced and skilled personnel in the market. However, when expansion does happen, this laboratory will be able to handle the entire load of national and international samples. Acton's business plan includes forays outside India as well, that may feature 'easy' countries like Singapore and Middle East. In the future, Acton will be focused on niche scientific advancements and will always work towards bringing genetic research to the common man.

sachin.jagdale@expressindia.com