the mantra of different strokes for different folks, new age diagnostic
companies can perhaps change the face of an industry that reels under
Aslight change in the tactics can pave the way for a radical
breakthrough, this is applicable to the Indian diagnostic market.
Growing at a rate of 15-20 percent, the market had been
facing myriad bottlenecks in its progress route and
was slammed by critics and market analysts as a highly
segmented market that sans regulation and parliamentary pathways. Now
that can be passé as the industry is heading for a complete
makeover. Backed by the spirit of entrepreneurship, rising
awareness among the Indian populace about the concept of
modern healthcare coupled with India being recognized as a genetically
heterogeneous country, the diagnostic market is now witnessing the
flourishing of new age diagnostic companies.
So what are these new age diagnostic companies and what distinguishes
them from the companies who had been dominating the scenario till date?
The terminology coined is ‘New Age’ because these
companies have taken the plunge to explore new territories and divert
their focus from the usual business models pursued by most of the
Indian companies till date. So today we have companies looking at core
businesses like diagnostic testing of patients at the genetic level in
order to prescribe medicines and drugs suited to the
patient’s metabolism rate and single-nucleotide polymorphism
(SNP), tests looking at gene mutations, manufacture
of antigens from natural and cell derived sources. The cost-effective
quotient of these methodologies are the icing on the cake. Though at an
initial stage of growth, these methodologies can fuel the growth for an
industry reeling under clogged growth.
BioSpectrum, has kept a close watch on market trends across the country
and has managed to bring those companies, who have adopted unique
business models to explore the untrodden path, to the limelight.
Yashraj Biotechnology Ltd
(YBL) is established in 1999. It is the brainchild of Arvind
K Bhanushali, the founder director of the company and his
brother Paresh B Bhanushali, the director of R&D and production
at Yashraj Biotechnology Ltd.
YBL deals with the business of manufacturing and supply of diagnostic
antigens, which are native, cell derived and antibodies, mainly
monoclonal, to kit manufacturers and distributors. The company had
received the FDA (India) license and ISO 90001:2000 certification in
2002 for the manufacture of these antigens and antibodies.
Dr Chander P Puri, CEO, YBL, who has in his kitty research projects in
molecular diagnostics, hormone-receptor interaction, pharmacokinetics,
pharmacodynamics and toxicology, said, “ We extract
these antigens from the human biomedical waste, especially the human
saliva. Usually these biomedical fluids are disposed off by hospitals
and so is left unused. YBL negotiates with these hospitals to have a
storage center for these biomedical waste which is subsequently
transported to our laboratories. This ultimately comes under affordable
diagnostics. Affordable because the ingredients which further
go into the diagnostic kits are indigenously produced. We were always
looking at methods which could be affordable to the people.”
“Currently we are manufacturing antigens of native human
origin, which can be used either as standards or calibrators in various
assay formats or immunogens for raising antibodies or for
laboratory-based research and development,” added Dr Puri.
The monoclonal antibody products will soon be available for use as
reagent in diagnostic kits.
At present, the company is focusing on diseases like tuberculosis,
malaria and sexually transmitted diseases like HIV/AIDS. YBL is also in
the process of coming out with a cell driven antigen for TB diagnosis
and one monoclonal antibody is under evaluation. Like for HIV/AIDS, YBL
is coming out with an antigen extracted from human saliva. YBL has
brought out 13 products into the market and nine products are in the
The research team also conducts a viral safety testing for all products
to be released. All source materials are tested for HbsAg, the surface
antigen of the Hepatitis-B-Virus (HBV), anti-HIV I/II and anti-HCV.
Only non-reactive material is used for processing. The non-reactive
released are tested for the absence of viral (HBV, HCV and HIV) genetic
material by PCR. HBV is not tested in
Yashraj is also in the business of contract manufacturing using the
company’s own or customer supplied raw material. In this
case, projects of antigens is taken up either through joint
R&D venture or exclusive technology transfer for buy back.
To augment its business, YBL has a scientific advisory board with
members like Prof. G Padmanabhan, who is the chairman of the
scientific advisory committee of Yashraj Biotechnology Ltd. The board
is responsible for brainstorming and hashing out ideas about
product manufacturing and accordingly charts a pathway for extraction
of antigens and antibodies from human biomedical fluids
YBL houses facility centers like the native antigen facility, cell
culture facility, quality control, R&D, experimental animal
facility. New business opportunities for YBL are in the areas
like supply of cell-derived antigens and antibodies, monoclonal
antibodies using hybridoma technology and polyclonal antibodies; cell
culture facility for expression of patented clones
(diagnostic and/or therapeutic) and the use of experimental animal
facility for drug development. YBL intends to come up with a 1,50,000
sq m facility, either for contract manufacturing or as a joint venture
Having achieved milestones and success in the indigenous production of
antigens and antibodies, YBL is now looking at diagnostic kits
manufacturing space. The company has already identified the
technologies, in talks with financiers and there are four buildings
already allotted for it. Also they are in talks with scientists from
all over the world.
The tagline of the company,
‘celebrating genetics’, best describes
Acton’s business model in a nutshell. Pune-based,
Acton Biotech, was founded on the scientific contention that different
people react differently to drugs because of their genetic structure.
This idea is well explained as four people represented in
red, blue, yellow and green. The person in red represents 60 percent of
the population, who respond positively to a drug; about 25 percent of
the population are fast metabolisers of the drug that means the drug
will get washed out of their body before it can have any positive
effect, this population is represented by the blue person; another 10
percent of the population are slow metabolisers, they are represented
by the yellow person, people in this population will have minor or
major side effects because of accumulation of the drug, as the drug
gets washed out very slowly and finally the green person represents the
remaining five percent of the population, which shows undetectable or
no enzyme activity and so all the drug taken in by the person keep
accumulating and this can cause severe side effects.
Throwing light on Acton’s business model Sandeep Saxena,
founder and CEO of the company said, “Nowadays, choosing a
drug for any complex disease like cancer is very difficult
because of the difference in the rates of efficacy of these drugs
amongst the Indian populace, as cancer drugs are inherently toxic to
some of them. This difference in efficacy is because of the variation
in metabolic rates of enzymes from person to person. Acton focuses on
the basic DNA code, checks for the enzymes that are responsible for the
metabolism, mutations in the genes and suggests drugs according to the
genetic structure of the person. This saves both cost and
Acton, an angel-funded company, has its genesis way back when
founder and chairman, Saxena was graduating with an MBA degree from
Nirma Labs affiliated with the Nirma University based in Gujarat.
“At the end of the course we are supposed to write
a business plan for our start-up company. If that plan would
be accepted then they would give us seed fund to initiate that
start-up. Our business plan finally got accepted for
incubation,” recollected Sandeep Saxena.
“We did a detailed study and got all the research
articles on pharmacogenomics and zeroed in on the important genes and
expressions and its functions. At that time we had no focus. We looked
into diseases like cancer, central nervous system (CNS) and depression.
Then we decided to focus on oncology as it is the most widely read and
researched field that boasts a huge market in India,” pointed
While commenting on the modus operandi of the company Sandeep Saxena
said, “We have a laboratory in Pune with the basic set of
equipments. We collect blood samples from all across the country, we
extract the genes while focusing on single points called single
nucleotide polymorphism (SNP). From our background research we got a
clear idea about the drug response in different patients.
Acton’s sales force educates doctors, update them on the
different drugs and the type of SNP they will positively
Acton now follows one gene-one drug correlation. Take for instance the
somatic KRAS gene mutation, which is responsible for therapy resistance
to tyrosine kinase inhibitors such as cetuximab, in the metastatic
colorectal cancer tissue. Around 40 percent of the population does not
show any response to the drug because of mutations in the KRAS gene.
Acton offers this KRAS gene mutation testing, which should be done
immediately after the diagnosis. According to the National
Comprehensive Cancer Network (NCCN), only patients with tumors of the
abnormal type of KRAS gene should receive treatment with the epidermal
growth factor receptor inhibitor cetuximab. For this type of genetic
testing already 30 patient samples have been analyzed by Acton and
tests have been repeated. Turnaround time for this test is 10 days and
tests are done after optimizing the DNA extraction from formalin fixed
paraffin embedded (FFPE) blocks and the polymerase chain reaction
“From January onwards we ramped up everything right from the
number of people, lab equipment and research by recruiting sales
managers and executives, we started opening up blood collection centers
in Mumbai, Hyderabad, Chennai, Baroda, Ahmedabad and Surat. We also
have tie-ups with hospitals in Delhi, Hyderabad, Bangalore and
Kolkata,” pointed out Saxena.
Acton intends to focus on areas like cardiology and diabetes.
“We are talking to cardiologists. This is a recent initiative
taken by the company. We believe that genetic tests will avoid severe
complications,” concluded Saxena.
Ch Srinivas Rao along with