Life Sciences informatics major, Bigtec Private Ltd has indigenously designed and developed a hand held point of care Micro Thermal Cycle Diagnostic Platform (MTCDP) to perform Hepatitis B and C tests. The platform is now undergoing clinical validation at the Centre for Liver Research and Diagnostics, Hyderabad. The validation will be complete next month after which the company will release the first prototype for custom manufacture. The company intends to license the technology for production and discussions are on with players in India and abroad.
The handheld diagnostic platform is for rapid pathogen detection of any disease and allows DNA amplification. But currently the company is validating the product specifically for Hepatitis B & C where with a single drop of blood the diagnosis can be made within 15 minutes. The diagnostic chip is based on BioMEMS and MEMS (Micro-Electro-Mechanical Systems). The sensing element is a bio-element which is Deoxyribonucleic acid (DNA) supported.
The product R&D took off under a soft loan grant from the Council of Scientific and Industrial Research's New Millennium India Technology Leadership Initiative (NMITLI) where a sum of Rs 6 crore was sanctioned for a 3-year-period. This tripartite research programme commenced in January 2006 with Bigtec supported by Indian Institute of Science and Indian Institute of Integrative Medicine, Jammu. A monitoring and advisory committee had the research scrutinized at every stage of progress.
A team of 16 scientists from the Bigtec Lab was responsible for the innovative research driven technology. The battery operated affordable device driven by mobile computing technology has a centralized access for data on diseases. It will revolutionize healthcare in the developed and developing world. While a company in Singapore is also developing a similar product based on the same technology for SARS virus detection, Bigtec's Micro Thermal Cycle Diagnostic Platform for Hepatitis B & C is a first-of-its-kind in the world, Chandrasekhar B Nair, director, Bigtec told Pharmabiz.
India has around 80 million Hepatitis B positive people and it is estimated that around 300 million tests are conducted annually. "Our platform is affordable for both healthcare providers and patients. A real time PCR platform costs Rs 25 lakh and a confirmatory Hepatitis test on PCR costs between Rs 5,000 and Rs 15,000. The Bigtec platform will be made available for approximately Rs 20,000 and a test would work out to only Rs 100," added Chandrasekhar.
As part of the future initiatives, Bigtec is working on their Micro Thermal Cycler Diagnostic Platform for various other infectious diseases.
The seven year-old Bigtec with a Rs 10 crore turnover has expertise in Bio-MEMS, biochemistry, immunology, molecular biology, portable electronics, synthetic chemistry and assay development. Its revenue streams are from phase I clinical trial software, and hospital information systems. Its value added assignments are in the areas of bio-therapeutics, hand held point of care, clinical trial Phase I software for quality labs and drug discovery and development. The company has a total strength of 250. Plans are underway to augment the team and it is also moving its lab from the present premises into the IISc campus in mid February. The company has also slated an investment of around Rs 15 crore for future product development efforts.