The threat of a "silent" liver disease epidemic looms over India, with the problem compounded by the absence of safe, reliable and affordable diagnostics - especially biopsies.
Now IndioLabs (IL), a Bangalore-based start-up, has come up with 'BioScoop', a cutting-edge, cost-effective procedure that could revolutionise the way a biopsy is done.
A biopsy is done to diagnose the extent and type of damage to the liver caused by hepatitis, cirrhosis or cancer, by extracting a tissue sample with a needle, especially after a chronic or abnormal condition is indicated by blood tests, an X ray or ultrasound.
Although biopsy is a key tool and a "gold standard" in diagnostics, the risk of internal bleeding, contamination, or infection cannot be ruled out, which could lead to sudden death.
"BioScoop extracts tissue automatically, eliminating the possibility of contamination and other problems associated with conventional biopsy, all in three seconds," Siraj Bagwan, IndioLabs MD who co-invented the device, told IANS."Also in a conventional biopsy, the needle has to be inserted a second time, if the first attempt fails to extract a tissue sample. When the second attempt fails, doctors have to perform a laproscopy guided biopsy. But BioScoop overcomes these problems," added Bagwan. Bagwan worked on the project under the Stanford-India Biodesign (SIB), a flagship biomedical programme of the All India Institute of Medical Sciences (AIIMS), the Indian Institute of Technology, Delhi and Stanford University, US, sponsored by the Union Ministry of Science and Technology.
"The device consists of a multi-functional needle that pierces the skin and cuts soft liver tissue in one clean 'scooping' action. It is integrated with a 'BxSeal' system, which delivers a sealant directly to the spot from where the tissue is removed to prevent blood-loss and complications," Bagwan said.
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A WHO report said the "silent" epidemic is likely to affect one out of every 10 Indians over the next decade, even as the hepatitis B variant alone kills an estimated 100,000 people in the country every year.
IndioLabs, the research arm of the Bangalore-based Omya Healthcare Ltd., has filed Indian and international patents for both technologies through Biotech Consortium India Ltd. and is pursuing regulatory approval for marketing clearance by 2014.
This device is expected to sell at half the price of its current closest competitor, enabling a cost-effective and definitive diagnosis for Indian patients and hospitals to curtail the silent epidemic, according to Tetali Murali Krishna Reddy, chairman of Omya Healthcare.
"The conservative estimate of the market size is of Rs.300 crore to Rs.500 crore for liver biopsy in India alone, even though this device can easily be extended to breast, kidney, lungs and prostate soft-organ biopsies, among others," said Reddy.
"IndioLabs is likely to launch 'BioScoop' in India by March 2015, followed by a phased global launch in the Asia-Pacific region, Europe and the United States," added Reddy.
BioScoop co-inventor Jonathan Pillai, said: "We are actively pursuing regulatory approvals in Europe and the US in a phased manner, with an initial focus on CE (European Conformity) approval and then the US-FDA clearance."
Hepatitis A, B, C, D and E, is caused by a group of viruses known as hepatitis viruses. They are usually spread by eating food or drinking contaminated water, or through sex, blood transfusions or needle sharing by intravenous drug-users. Biopsy may be done in the case of Hepatitis B, C and D.
This technology was presented at the VIIth Medtech Summit in New Delhi Dec 7.