Bangalore-based Bigtec Labs which developed a novel Micro Thermal Cycler Diagnostic Platform (MTCDP) has now proposed to extend its use for H1N1 detection for the surveillance/diagnosis of swine flu. The company is now in the process of initiating talks with the Ministry of Health officials to impress upon them about the utility of this diagnostic platform as a front-line screening device for faster and easier method of detecting swine flu at a much lower cost.

Using the MTCDP for the confirmation of the swine flu virus is one among the most critical applications of the diagnostic device which has already been validated with positive results for hepatitis B, chickungunya, dengue, malaria and bacterial infections. Current cost of a conventional PCR test is around Rs 3000 to 4000 for any diagnosis including swine flu. The same can be performed at a modest cost of Rs 300 with the Bigtec's hand held device.

"We have extensive data to show that the MTCDP can be used for any infectious disease. If the Ministry of Health approves our diagnostic device for H1N1 detection, we will provide the devices along with all details of the procedure to the National Institute of Virology (NIV), Pune and The National Institute of Communicable Diseases (NICD), New Delhi which are the only two nationally recognized centers for detection and handling of the Swine Flu virus for validation. Both NIV and NICD could compare the hand held device with the existing conventional PCR for validation," professor P V Subba Rao, president, R&D, Bigtec Labs told Pharmabiz.

"The portable point-of-care and globally patented Micro-PCR device costs about Rs 1 lakh against 15 to 20 lakh a conventional PCR machine. We are confident that our device at a highly reduced cost can facilitate faster, sensitive, reliable and safe way of point-of-care diagnosis that does not require a highly trained technician," he added.

"If we get approval, we can make MTCDP available for the government to install at all the international airports in the country within a reasonable time to facilitate the speeding up process of H1N1 diagnosis from the current two to four days to sixty minutes. This could combat the fears of the Swine Flu which has been declared as a pandemic by the World Health Organization (WHO)," stated professor Rao.

"Fast, accurate and reliable diagnosis of infectious diseases can be made available both for India and the whole world," said G M Kini, managing director, Bigtec.

The company initiated the development of the Micro PCR in the last five years with the concerted efforts of a group of young inter-disciplinary scientists. It has received NMITLI assistance to the tune of Rs 6 crore, in addition to internal fund source for research, development and validation.

The clinical validation of MTCDP to diagnose hepatitis-B was successfully completed at the Center for Liver Research and Diagnostics (CLRD), Hyderabad. Bigtec is now working on validation of other infectious diseases at different hospitals.

In association of with the Institute of Animal Health and Veterinary Biologicals, Bangalore, Bigtec is working on the application of their hand-held Micro PCR Device for rapid diagnosis of various bacterial and viral diseases in farm animals.

For the future, Bigtec is aggressively working towards hand-held point-of-care diagnostic devices for major diseases inflicting the mankind based on their lab-on-chip concept.