In a bid to advance its biomedical diagnostic research and development efforts, Bigtec Private Limited has opened a state-of-the-art laboratory at the Society for Innovation & Development (SID) Entrepreneurship Centre in the Indian Institute of Science (IIsc) Campus, Bangalore at an investment of Rs. 10 crore.

The company which has funds for setting up the lab from internal accruals and internally generated debt is now in talks with venture capitalists to raise $ 10 million for market penetration of its much-sought after Micro Thermal Cycler Diagnostic Platform (MTCDP) to diagnose hepatitis B and C.

The lab will focus on advanced multidisciplinary research to develop simplified diagnostic kits utilizing the disciplines of MEMS, optics, molecular biology, bioinformatics and information technology. In this connection, it has started associating with scientists at IISc in the areas of infectious diseases and nanotechnology. The research team spearheaded by Prof. PV Subba Rao has 20 scientists which include four from the reverse brain drain sector who constitute post doctorates in MEMS, chemical biology, optics and microfludics.

Meanwhile, the company is all set for the clinical validation of its MTCDP to perform Hepatitis B and C tests at the Centre for Liver Research and Diagnostics (CLRD), Hyderabad. The study is classified as a non inferiority trial where the data is statistically being evaluated on the efficacy of the diagnostic chip BIOMEMS (Micro-Electro-Mechanical Systems) developed in-house. The study will be carried out on 150 patients to begin with. The results of the 150 samples are expected by July after which clearances will be sought from the appropriate regulatory authority in India for multi centric clinical trials in the country, stated GM Kini, managing director, Bigtec.

CLRD is a DCGI and CDC, Atlanta approved centre for liver diseases. For extended trials, the company is expected to carry out studies at AIIMS, New Delhi and PGI, Chandigarh, stated Prof. Rao.

The chip is based on BioMEMS and MEMS. The sensing element is a biomolecule which is Deoxyribonucleic acid (DNA) based. The company is in talks with an European manufacturer for the production of chips. The hand held diagnostic platform aimed at pricing around Rs 20,000 will be developed by a third party manufacturer in the country.

"The portable miniaturized detection system which is battery operated will revolutionize health care diagnostics as it can be used any where from a remotely located primary health centre to an advanced hospital. The platform could also be used to conduct epidemiology studies to control epidemics. The data can be transferred to a central location for health analysts to collate the information of the epidemic for various purposes," explained Kini.

Capitalizing on the multiple applications of BioMEMS, the company is also working towards replicating the chip for diagnosis of Chikungunya, dengue and malaria. Initial studies are underway, stated Prof. Rao.

It is also working on a quick and cost-effective detection system for biomarkers based on a simple hand held platform. This will allow rapid detection of certain chronic and acute diseases at doctor's clinic or primary health care centres.